Atlas FDA

FKX

83 FDA 510(k) clearances · Product code

81 daysmedian time to decision
223 days90th percentile
83clearances measured

FDA profile

Official device name
System, Peritoneal, Automatic Delivery
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5630
Medical specialty
Gastroenterology, Urology
Flags
Life-sustaining
Adverse events (MAUDE)
2021: 5,076 · 2022: 4,503 · 2023: 3,913 · 2024: 3,771 · 2025: 3,180 · 2026: 1,718
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Archimedes Pro Automated Peritoneal Dialysis Cycler (3014-00000-1); Archimedes Standard Automated Peritoneal Dialysis Cycler (3014-00000-3); Archimedes Pro Disposable Tubing Set (3014-50000-1); Archimedes Standard Disposable Tubing Set (3014-50000-3); Archimedes Pro Plus Disposable Tubing Set (3014-50000-5) (K250523)Simergent, LLC2025-10-02
Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1 (K243371)Byonyks Pvt, Ltd.2025-05-16
Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical Supervision Portal and IDA Smartphone App (K220935)Iren-Medical, Ltd.2022-12-29
Fresenius Liberty Select Cycler (K222318)Fresenius Medical Care Renal Therapies Group, LLC2022-10-31
Lilliput APD System (K212522)Fresenius Medical Care Renal Therapies Group, LLC2022-04-15
CloudCath Peritoneal Dialysis Drain Set Monitoring System (K212658)Cloudcath2022-02-09
Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD System (K201867)Baxter Healthcare Corporation2020-11-19
Fresenius Liberty Select Cycler (K181108)Fresenius Medical Care Renal Therapies Group, LLC2018-05-24
Liberty Cycler Set (K173718)Fresenius Medical Care Renal Therapies Group, LLC2018-05-01
Fresenius Liberty Select Cycler (K171652)Fresenius Medical Care Renal Therapies Group, LLC2017-09-15
Amia Automated PD System with Sharesource (K151525)Deka Research and Development2015-10-09
LIBERTY PDX CYCLER (K141145)Fresenius Medical Care Renal Therapies Group, LLC2014-07-30
FRESENIUS LIBERTY CYCLER (K123630)Fresenius Medical Care North America, Design Cente2013-09-09
AMIA AUTOMATED PD SYSTEM (K124018)Deka Research & Development Corp.2013-06-14
VOYAGER PERITONEAL DIALYSIS SYSTEM (K103220)Deka Research & Development Corp.2011-07-29
HOMECHOICE/HOMECHOICE PRO AUTOMATED PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM MODEL 5C4471, 5C8310, 5C4471R AND 5C8310R (K102936)Baxter Healthcare Corp2011-03-30
HOMECHOICE/HOMECHOICE PRO PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C4471 AND 5C8310 (K053512)Baxter Healthcare Corp2006-02-16
FRESENIUS LIBERTY CYCLER (K043363)Fresenius Medical Care North America2005-03-31
HOMECHOICE PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C8310, 5C8302, 5C4471, 5C4469 (K012988)Baxter Healthcare Corp2001-12-05
FRSENIUS PD IQCARD CYCLER (K002892)Fresenius Medical Care North America2001-04-05
EASY CARE AND TUBING SETS (K994218)Medionics International, Inc.2000-02-10
BAXTER NIGHT EXCH DEVICE(NXD) PERITONEAL DIALY SYST (K935659)Baxter Healthcare Corp1994-07-07
BAXTER PERSONAL CYCLER AUTOMMATED PERITONEAL DIAL (K923065)Baxter Healthcare Corp1994-03-04
R & D BATTERIES,INC. PART NUMBERS 5164, 5272, 5260 (K933687)R & D Batteries, Inc.1994-02-09
NMC CYCLER MACHINE (K905809)National Medical Care, Medical Products Div., Inc.1992-02-25
SELECTRA AND TUBING SETS (K910173)Medionics International , Ltd.1992-01-13
FRESENIUS/DELMED 90/2 PERITONEAL DIALYSIS SYSTEM (K902149)Fresenius/Delmed, Inc.1990-10-30
DELMED 80/2 DIALYSIS SYSTEM W/LAST BAG OPTION (K901478)Delmed, Inc.1990-07-27
DELMED 80/2 DIALYSIS SYSTEM W/ULTRAFILTRATION (K901477)Delmed, Inc.1990-07-27
MULTI-STRIP (K901228)Bellhouse Medical, Inc.1990-05-07
ABBOTT INPERSOL CYCLER 1000 (K895336)Abbott Laboratories1989-11-28
PERITONEAL CATHETER STABILIZATION DEVICE 5C4381 (K884554)Baxter Healthcare Corp1989-01-31
BENT NECK CURLCATH PERITONEAL DIALYSIS KIT (K874632)Quinton, Inc.1987-12-29
UPGRADED AUTO PERITONEAL DIALYSIS CYCLER SYSTEM (K872652)Travenol Laboratories, S.A.1987-09-30
AMUKIN-50% FOR CAPD Y-SET (K862928)Amuchina Intl., Inc.1987-03-09
ABBOTT INPERSOL CYCLER 1000 (K845042)Abbott Laboratories1985-03-19
ROPE SYSTEM REVERSE OSMOSIS PERITONEAL SYSTEM (K844630)Organon Teknika Corp.1985-03-12
AUTOMATIC PERITONEAL DIALYSIS CYCLER SYSTEM (K850406)Travenol Laboratories, S.A.1985-02-21
RENAL SYSTEMS PERITONEAL ACCESS SYSTEM (K844108)Renal Systems, Inc.1985-01-07
SCD STERILE CONNECTION DEVICE (K844144)E.I. Dupont DE Nemours & Co., Inc.1984-11-16
EXTENDED LIFE CAPD SOLUTION TRANSFER (K842885)Travenol Laboratories, S.A.1984-10-18
LIFEMED LIFECOIL CATHETERS (K841929)Lifemed of California1984-08-08
C.A.P.D. AUTOMATIC HEATER PDH 200 (K842305)Medionics International , Ltd.1984-06-25
EXTENDED LIFE CAPD SOLUTION TRANSFER (K840224)Travenol Laboratories, S.A.1984-02-21
PERITONEAL CATHETER-CHANGES- (K833749)Quinton, Inc.1983-12-27
CAPD ULTRAVIOLET GERMICIDAL EXCHANGE (K833595)Travenol Laboratories, S.A.1983-11-29
AUTOMATIC PERITONEAL DIALYSIS CYCLER (K833065)Travenol Laboratories, S.A.1983-11-28
MICROSTAR VCI (K831766)Medionics International , Ltd.1983-10-14
MICROSTAR VC1 VOLUMETRIC CYCLER (K832141)Medionics International , Ltd.1983-10-14
CAPD - CATHETER ADAPTER (K831716)American Mcgaw1983-06-24
AMPERCIDE DISINFECTANT ACCESSORY TO - (K830881)American Medical Products, Inc.1983-06-02
EMPTY DIALYSATE CONTAINER BB-69 (K830689)Delmed, Inc.1983-03-29
ABBOTT PATIENT ASSIST DEVICE (K830766)Abbott Laboratories1983-03-29
AMP 80/2 OUTFLOW MONITOR MODIFICATION (K823827)American Medical Products, Inc.1983-03-17
BETA-CAP D ADAPTER (K830208)Quinton, Inc.1983-03-07
NON-STERILE PERITONEAL ACCESS CATHET- (K830257)Evermed, Inc.1983-02-24
IMPRA PERITONEAL CATHETER (K823857)Impra, Inc.1983-01-26
PC 201A LOCKING SLEEVE (K823390)Medigroup1983-01-26
PC-204 TUNNELOR (K823331)Medigroup1983-01-26
QUILL CATHETER GUIDE (K823303)Medigroup1983-01-26
PC-205 TENCKHOFF CATHETER ROD OBTURATOR (K823296)Medigroup1983-01-26
DIALATORS PC-203 & 202 (K823330)Medigroup1983-01-26
STERILE, DISPOS. SPIKE PROTECTOR-5C4138 (K823777)Travenol Laboratories, S.A.1983-01-07
INPERSOL PERITONEAL DIALSIS CYCLER SET (K823217)Abbott Laboratories1982-11-30
INPERSOL-CAPD ADMINIS. SET TYPE DP (K822712)Abbott Laboratories1982-10-21
EXTENSION SET TYPE DP (K822658)Abbott Laboratories1982-10-21
CCPD CYCLER SET W/5 PRONGED CONNECTOR (K822545)American Medical Products, Inc.1982-10-13
SAFE LOCK TITANIUM ADAPTER SET (K822550)American Medical Products, Inc.1982-10-13
CAPD SAFE LOCK TRANSFER SET (K822543)American Medical Products, Inc.1982-10-13
SAFE LOCK CATHETER S-3 (K822548)American Medical Products, Inc.1982-10-13
CCPD CYCLER SET W/5 PRONGED SAFE LOCK (K822549)American Medical Products, Inc.1982-10-13
SAFE LOCK SEALING CAP L (K822544)American Medical Products, Inc.1982-10-13
SAFE LOCK SEALING CAPS (K822546)American Medical Products, Inc.1982-10-13
AUTOMATIC SPLICING DEVICE (K822025)E.I. Dupont DE Nemours & Co., Inc.1982-09-09
CAPD BELT (K822547)American Medical Products, Inc.1982-09-09
DIANEAL SOLUTION EXCHANGE DEVICE #5C4193 (K822361)Travenol Laboratories, S.A.1982-08-16
ERIKA CAPD PREP KIT #30-9501-5 (K820179)Erika, Inc.1982-02-19
CATHETER BUBBLE STAND (K813487)Accurate Surgical Instruments Co.1981-12-31
THE AMP 80/2 PEDIATRIC CYCLER SYSTEM (K811986)American Medical Products, Inc.1981-08-31
CAPD CATHETER ADAPTER (K810683)American Mcgaw1981-05-08
ADR-10600(ADR 400),10601 (ADR 300) (K791342)Physio-Control Corp.1979-11-16
DIALYSIS DRAINAGE UNIT, PERITONEAL (K772150)C.R. Bard, Inc.1977-11-28
RINSE BLOCK ASSEM, D-W PERI. DIALYSIS (K771484)Quinton, Inc.1977-10-25

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