Atlas FDA

KDJ

113 FDA 510(k) clearances · Product code

77 daysmedian time to decision
224 days90th percentile
113clearances measured

FDA profile

Official device name
Set, Administration, For Peritoneal Dialysis, Disposable
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5630
Medical specialty
Gastroenterology, Urology
Flags
Life-sustaining
Adverse events (MAUDE)
2021: 3,167 · 2022: 2,927 · 2023: 2,947 · 2024: 3,113 · 2025: 2,491 · 2026: 1,049
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
stay•safe® catheter extension set with Safe- Lock, 12 inch; stay•safe® catheter extension set with Luer-Lock, 6 inch; stay•safe® catheter extension set with Luer-Lock, 12 inch; stay•safe® catheter extension set with Luer-Lock, 18 inch; stay•safe® to Luer-Lock Adapter, 4 inch (K250404)Fresenius Medical Care Renal Therapies Group, LLC2025-04-03
MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A; MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short - Code 5C4483 (K231849)Baxter Healthcare2024-03-12
15L Cycler Drainage Bag (K214016)Baxter Healthcare Corporation2022-03-18
MiniCap Extended Life PD Transfer Sets (K192705)Baxter Healthcare2019-10-25
stay•safe catheter extension set with Safe-Lock, 12 inch, stay•safe catheter extension set with Luer-Lock, 6 inch, stay•safe catheter extension set with Luer-Lock, 12 inch, stay•safe catheter extension set with Luer-Lock, 18 inch, stay•safe to Luer-Lock adapter, 4 inch (K173593)Fresenius Medical Care Renal Therapies Group, LLC2018-05-21
Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set (K173651)Fresenius Medical Care Renal Therapies Group, LLC2018-02-14
Cycler Drain Bag Set (K173363)Fresenius Medical Care Renal Therapies Group, LLC2018-01-24
Firefly Peritoneal Dialysis Connector Disinfection System (K151620)Puracath Medical, Inc.2016-01-20
FlexiCap Disconnect Cap with Povidone-Iodine Solution, MiniCap with Povidone-Iodine Solution (K152129)Baxter Healthcare Corporation2015-10-29
EXTENDED LIFE CAPD TRANSFER SET, PERITONEAL DIALYSIS TITANIUM CATHETER ADAPTER AND LOCKING CAP FOR TITANIUM CATHETER ADAPTER (K152675)Baxter Healthcare2015-10-29
APD LUER-LOCK ADAPTER (K124024)Fresensius Medical Care North America2013-09-19
FRESENIUS STERILE STAY SAFE CAP (K083542)Fresenius Medical Care North America2008-12-29
K.E.P. CONNECTOR AND CLIP (K042900)K.E.P., LLC2004-11-05
FRESENIUS STAYSAFE PATIENT CONNECTORS, MODEL 050-87211 (K041792)Fresenius Medical Care North America2004-09-24
HOMECHOICE APD SET WITH LINEO CONNECTOR, MODELS 5C4469Q, 5C4468Q, 5C4531Q, 5C8302Q, 5C4599Q (K031676)Baxter Healthcare Corp2003-11-20
FRESENIUS CAPD STAY.SAFE DISPOSABLE ADMINISTRATION SETS WITH STAY.SAFE CONNECTOR (K022412)Fresenius Medical Care North America2003-03-05
PDM3 DISINFECTION SYSTEM FOR PERITONEAL DIALYSIS EXCHANGES, PATIENT TRANSFER SET PTS102, CAP, HIGH TEMPERATURE (K974387)Microwave Medical Systems, Inc.1999-09-01
HIGH DOSE DISCONNECT CAP AND MINICAP WITH POVIDONE-IODINE, HIGH DOSE DISCONNECT CAP WITH POVIDONE-IODINE (K972579)Baxter Healthcare Corp1997-10-01
NEO-CARE PERITONEAL DIALYSIS ADMINISTRATION SET (K972731)Klein-Baker Medical, Inc.1997-09-29
MEDISYSTEMS PERITONEAL DIALYSIS SETS (K963668)Medisystems Corp.1997-08-15
ULTRASET/3L CAPD DISPOSABLE DISCONNECT Y-SET MODELS 5C4366 & 5C4493 (K961825)Baxter Healthcare Corp1996-08-06
QC CAP (K945567)Medionics International, Inc.1995-02-07
RAPID DISCONNECT Y-SET, CAT. NO. 48-7000 (K930843)National Medical Care, Medical Products Div., Inc.1994-08-31
ABBOTT SMART CAP (K921818)Abbott Laboratories1994-03-28
BAXTER APD 12' EXTENSION LINE (K925403)Baxter Healthcare Corp1994-02-22
FRESENIUS VARIABLE FILL MONITOR (K921052)Fresenius USA, Inc.1993-02-25
DEXTROLYTE II PERITONEAL DIALYSIS ADMIN. SET (K920586)National Medical Care, Medical Products Div., Inc.1992-09-21
DEXTROLYTE II CAPD TRNSFER SET (K920029)National Medical Care, Medical Products Div., Inc.1992-09-21
DEXTROLYTE II PERITONEAL DIALYSIS PUMP (K915628)National Medical Care, Medical Products Div., Inc.1992-03-16
ABBOTT SMART CAP (K915304)Abbott Laboratories1992-02-19
FRESENIUS SAFE-CONNECT CAPD MANUAL ASSIST DEVICE (K912208)Fresenius USA, Inc.1991-07-24
CAPD SAFELOCK TRANSFER SET W/PRE-FILLED CONNECTOR (K904806)Fresenius USA, Inc.1991-01-11
PERITONEAL DIALYSIS STYSTEM AND ACCESSORIES (K900295)Microwave Medical Systems, Inc.1990-11-21
CAPD DISPOSABLE DISCONNECT Y-SET CODE: 5C4481 (K902526)Baxter Healthcare Corp1990-11-20
90/2 PERITONEAL DIALYSIS SYSTEM DISPOS CYCLER SET (K903869)Fresenius/Delmed, Inc.1990-11-20
LONG-LIFE Y-SET CAT. NO. 48-6366-8 (K902451)National Medical Care, Medical Products Div., Inc.1990-08-14
CLOSED DISCONNECT SYSTEM (K900106)Delmed, Inc.1990-07-16
CATHETER EXTENSION SET CAT. NO. 48-3027-9 (K895992)National Medical Care, Medical Products Div., Inc.1990-03-23
DEXTROLYTE II CAPD TRANSFER SET - NO. 48-4009-6 (K895792)National Medical Care, Medical Products Div., Inc.1990-03-23
PERITONEAL DIALYSIS CYCLER SET (K900323)National Medical Care, Medical Products Div., Inc.1990-03-22
DEXTROLYTE II, PERITONEAL DIALYSIS CYCLER SET -(8) (K896599)National Medical Care, Medical Products Div., Inc.1990-03-22
DEXTROLYTE II, PERITONEAL DIALYSIS NO. 48-1015-6 (K900243)National Medical Care, Medical Products Div., Inc.1990-03-22
DEXTROLYTE II, W/5 PRONG MANIFOLD NO. 48-1100-6 (K900141)National Medical Care, Medical Products Div., Inc.1990-03-22
DEXTROLYTE II PERITONEAL DIALYSIS CYCLER SET (K895990)National Medical Care, Medical Products Div., Inc.1990-03-22
DEXTROLYTE II, PERITONEAL DIALYSIS CYCLER SET (K900012)National Medical Care, Medical Products Div., Inc.1990-03-22
DEXTROLYTE II, PERITONEAL DIALYSIS CYCLER SET (K900008)National Medical Care, Medical Products Div., Inc.1990-03-22
DEXTROLYTE II, PERITONEAL DIALYSIS NO. 48-1031-3 (K900242)National Medical Care, Medical Products Div., Inc.1990-03-22
PERITONEAL DIALYSIS DRAINAGE SET NO. 48-0025-6 (K895991)National Medical Care, Medical Products Div., Inc.1990-03-22
DEXTROLYTE II, SINGLE USE Y SET NO. 48-6360-1 (K896600)National Medical Care, Medical Products Div., Inc.1990-03-22
DEXTROLYTE II, W/5 PRONG MANIFOLD NO. 48-1003-2 (K900142)National Medical Care, Medical Products Div., Inc.1990-03-22
DEXTROLYTE II, PERITONEAL DIALYSIS CYCLER SET W/3 (K900140)National Medical Care, Medical Products Div., Inc.1990-03-22
DEXTROLYTE II, PERITONEAL DIALYSIS NO. 48-1001-6 (K900226)National Medical Care, Medical Products Div., Inc.1990-03-22
DEXTROLYTE II, MANUAL ADMINISTRATION SET 48-1032-1 (K900005)National Medical Care, Medical Products Div., Inc.1990-03-02
CATHETER ADAPTER SEALING CAP NO. 48-1028-9 (K900006)National Medical Care, Medical Products Div., Inc.1990-02-27
CONVERTIBLE ADAPTER CATALOG NO. 48-4039-3 (K900004)National Medical Care, Medical Products Div., Inc.1990-02-27
QUICK DISCONNECT CLAMP CATALOG NO. 48-0300-3 (K896956)National Medical Care, Medical Products Div., Inc.1990-02-27
TRANSFER SET SEALING CAP, CAT. NO. 48-1027-1 (K896761)National Medical Care, Medical Products Div., Inc.1990-02-26
CATHETER ADAPTER CO-PAK CATALOG NO. 48-0122-1 (K896763)National Medical Care, Medical Products Div., Inc.1990-02-26
UNIVERSAL CONNECTOR CATALOG NO. 48-1025-5 (K896764)National Medical Care, Medical Products Div., Inc.1990-02-26
CONNECTION SHIELDS CODES 5C4213 AND 5C4215 (K895673)Baxter Healthcare Corp1990-01-29
DISCONNECT CAPS PRODUCT CODES 5C4212 AND 5C4466 (K895631)Baxter Healthcare Corp1990-01-29
PERITONEAL DIAL. TITA. CATH ADAPTER & LOCKING CAP (K894783)Baxter Healthcare Corp1989-09-07
PERITONEAL DIALYSIS SYSTEM AND ACCESS. (K893712)Delmed, Inc.1989-07-24
DELCLAMP (K893231)Delmed, Inc.1989-06-08
PERITONEAL DIALYSIS CYCLER SET W/12 PRONG MANIFOLD (K892872)National Medical Care, Medical Products Div., Inc.1989-05-18
PERITONEAL DIALYSIS CYCLER SET, W/5 PRONG MANIFOLD (K892870)National Medical Care, Medical Products Div., Inc.1989-05-18
PERITONEAL DIALYSIS CYCLER SET, W/8 PRONG MANIFOLD (K892871)National Medical Care, Medical Products Div., Inc.1989-05-18
CAPD DISPOSABLE Y SYSTEM - DY SET (K883393)Medionics International , Ltd.1988-11-03
CAPD ULTRAVIOLET(U.V.) GERMICIDAL EXCHANGE DEV SYS (K883239)Baxter Healthcare Corp1988-10-21
EXTENDED LIFE CAPD TRANSFER SET 5C4444 (K882498)Baxter Healthcare Corp1988-07-13
EXTENDED LIFE CAPD SOLUTION TRANSFER SET IC4373 (K882455)Baxter Healthcare Corp1988-07-13
AUTOMATIC PERITONEAL DIALYSIS CYCLER SET (5C4437) (K873984)Travenol Laboratories, S.A.1987-10-20
DELFLEX RIGID DRAIN CONTAINER (K871155)Delmed, Inc.1987-07-16
MODIFIED LABELING FOR AMUKIN-50% (K871583)Amuchina Intl., Inc.1987-07-09
FREEDOM SET II WITH TRIFLEX VALVE (K870626)Delmed, Inc.1987-06-03
DELFLEX SAFE LOCK CAPD PATIENT ASSIST DEVICE (K871154)Delmed, Inc.1987-04-30
CAPD Y-ADMIN. SET USED W/INPERSOL BIOCAP ADMIN. (K871049)Abbott Laboratories1987-04-10
CAPD ADMIN. SET USED W/INPERSOL CAPD BIOCAP Y-ADM. (K871050)Abbott Laboratories1987-04-10
EXTERNAL Y VALVE 5C4198 (K870145)Travenol Laboratories, S.A.1987-03-10
CAPD DISCONNECT SYSTEM 5C4182, 5C4183, 5C4186 (K860700)Travenol Laboratories, S.A.1986-04-07
CAPD TRANSFER SET SPIKE 5C4363 (K860230)Travenol Laboratories, S.A.1986-02-05
TRAVENOL CAPD Y SET 5C4354 (K853550)Travenol Laboratories, S.A.1985-10-04
CAPD TRANSFER SET FOR REDUCED FILL VOLUMES 5C4353 (K852678)Travenol Laboratories, S.A.1985-07-29
COMPACT EXCHANGE DEVICE 5C4197 (K851208)Travenol Laboratories, S.A.1985-04-08
EXTENDED LIFE CAPD SOLUTION TRANSFER SET 5C4153 (K851207)Travenol Laboratories, S.A.1985-04-08
CARD U.V. GERMICIDAL CHAMBER II (K820546)Travenol Laboratories, S.A.1982-06-30
CAPD U.V. GERMICIDAL CONNECTION SYSTEM (K812802)Travenol Laboratories, S.A.1982-03-02
PERITONEAL DIALYSIS CYCLER SET (K813069)American Medical Products, Inc.1981-11-16
PERITONEAL DIALYSIS CYCLER SET (8UNIT) (K812772)Dravon Medical, Inc.1981-10-19
PERITONEAL DIALYSIS DRAINAGE (K812771)Dravon Medical, Inc.1981-10-19
STERI-TRACT (K811863)Rogo Ent.1981-09-21
SPIKE GUARD (K812130)Clinipad Corp.1981-09-09
GAMBRO PERITONEAL DIALYSIS FLUID LINES (K811294)Gambro, Inc.1981-06-12
AMP PERITONEAL DIALYSIS PREP KIT (K810840)American Medical Products, Inc.1981-04-29
CCPD 3 LITER DRAINAGE SET (K810671)American Medical Products, Inc.1981-03-24
CCPD CYCLER SET (K810670)American Medical Products, Inc.1981-03-24
CAPD EXCHANGE SET (K810600)American Mcgaw1981-03-24
INPERSOL CAPD BAG PORT CLAMP (K803300)Abbott Laboratories1981-01-29
INPERSOL-CAPD ADMINISTRATION SET (K801881)Abbott Laboratories1980-10-10
INPERSOL CAPD ADMIN. SET & CATHETER ADAP (K800993)Abbott Laboratories1980-08-12
Next →

Track KDJ automatically

Every clearance here is in the API, with alerts when new ones post.