Atlas FDA

FPK

64 FDA 510(k) clearances · Product code

61 daysmedian time to decision
207 days90th percentile
64clearances measured

FDA profile

Official device name
Tubing, Fluid Delivery
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5440
Medical specialty
General Hospital
Flags
Third-party review eligible
Adverse events (MAUDE)
2015: 15 · 2016: 12 · 2017: 15 · 2023: 15 · 2025: 30 · 2026: 24
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
MEDRAD TWIST & GO HIGH PRESSURE CONNECTOR TUBING (K131517)Medrad, Inc. / Bayer Medical Care, Inc.2013-08-02
DISPOSABLE TRANSFER SETS WITH AND WITHOUT SWABBABLE VALVES AND/OR CHECK VALVES (K063114)Coeur, Inc.2007-02-09
LIFESHIELD LATEX-FREE GRAVITECH FLOW CONTROLLER I.V. SETS, MODELS 17528, 17527, 17525 & 17526 (K063239)Hospira, Inc.2006-12-11
MEDTRONIC MINIMED LEAPFROG II INFUSION SET, MODELS MMT-801S1, MMT-801L1, MMT-801S2, MMT-801L2, MMT-803S1 (K052431)Medtronic Minimed2005-11-29
EMPOWER TRANSFER SET, (CAT. NO. 7725) (K041178)E-Z-Em, Inc.2004-07-16
MEDRAD SWABBABLE VALVE TRANSFER SET (K031808)Medrad, Inc.2003-07-11
MEDRAD TRANSFER SET (K022431)Medrad, Inc.2002-09-05
POLYFIN EXTENSION SET, MODELS 126 AND 128 (K965208)Medtronic Minimed1997-02-26
SILCLEAR TUBING (MODIFICATION) (K953864)Degania Silicone , Ltd.1995-11-06
SYSMEX SF-3000 (K950508)Sysmex Corp.1995-11-03
EXTENSION SET/I.V. SET (K952243)Coast Medical, Inc.1995-07-26
60 MICRO VOLUME EXTENSION SET W/.22 MICRON FILTER, 21 EXTENSION SET W/1.2 MIVTON GILYRT, INJ. SITE, CLAMP (K952663)Distronic Sterile Products, Inc.1995-07-14
RECONSTITUTION ACCESSOREIS (K950861)Organon, Inc.1995-05-26
EXTENTION SET (K933524)Mediziv Medical Products 1987 , Ltd.1995-05-23
IVID (K950200)Scott/Ross Designs, Inc.1995-03-24
SILCLEAR TUBING (K943992)Degania Silicone , Ltd.1995-03-16
VARIOUS TUBING (K943206)Prn Services, Inc.1995-03-09
INTRAVASCULAR ADMINISTRATION SET (K945184)Distronic Sterile Products, Inc.1995-02-08
LIFESHIELD EXTENSION SET (K941214)Abbott Mfg., Inc.1994-10-03
EVANS MEDICAL EXTENSION SETS (K935642)Evans Medical, Inc.1994-01-28
NON-INVASIVE TUBING (K921450)Specialty Medical Sales, Inc.1993-02-05
OPHTHALMIC FLUID DISTRIBUTION SETS (K923972)Visitec Co.1992-11-04
LO-PROFILE EXTENSION SET (K915560)Douglas Medical Products Corp.1992-05-14
LIFESHIELD EXTENSION SET (K912103)Abbott Laboratories1991-12-13
CENTURION KLEEN-NEEDLE SYSTEM I.V. EXTENSION SETS (K910906)Tri-State Hospital Supply Corp.1991-04-01
INTRAVASCULAR ADMINISTRATION SET MODEL 60040 (K891009)3M Company1989-05-16
INTRAVASCULAR ADMINI. SET MODELS 60030 & 60050 (K891005)3M Company1989-05-11
MERIT HI-FLEX(TM) (K883718)Merit Medical Systems, Inc.1989-01-30
HYPERBARIC INTRAVENOUS INFUSION EXTENSION SET (K884156)Sechrist Industries, Inc.1988-11-14
CMS IV EXTENSION SETS (K884370)Churchill Medical Systems, Inc.1988-11-07
IV EXTENSION SET (K875186)Marquette Medical, Inc.1988-02-16
VAN DELLEN BACTERIA FILTER (K873465)Van Dellen, Ltd.1988-01-20
INFUSION MANIFOLD (K873852)Advanced Surgical Products, Inc.1987-11-23
PLASTIC TUBING CONNECTOR (K874360)American Medical Technology, Inc.1987-11-17
EXTENSION TUBE PUMP SET (K871085)Churchill Corp.1987-06-15
SWIVEL CONNECTORS #014452/#014453/#014459-120 (K871540)Clinical Connections, Inc.1987-04-30
LP EXTENSION SETS (K870416)North Coast Medi-Tek1987-04-06
T-CONNECTORS 014500/014501/014502/014503-120 (K870912)Clinical Connections, Inc.1987-03-17
VARIOUS LUER AND TUBING FITTINGS (K870326)Clinical Connections, Inc.1987-02-10
EXTENSION SETS (K864692)Salt Creek Medical Technologies1986-12-18
LOW VOLUME EXTENSION SET (K864395)Panamedix, Inc.1986-12-16
CHURCHILL EXTENSION TUBE (K861626)Churchill Corp.1986-06-02
CHURCHILL-H EXTENSION TUBE (K854629)Churchill Corp.1985-12-10
SPINAL NEEDLES & ACCESSORY (K834164)Elfa Trading Co.1983-12-13
IV EXTENSION SET (K833659)Dna Medical, Inc.1983-11-29
C-FLEX MEDICAL GRADE TUBING (K833076)Concept, Inc.1983-11-21
RED COLOR-TINTED TUBING (K832758)Custom Medical, Inc.1983-09-12
ANESTHESIA EXTENSION TUBES (K820527)David Simmonds Co., Inc.1982-03-18
FLUVEN SETS (EXT-1, EXT-2, EXT-3, EXT-4) (K812981)Venusa , Ltd.1981-11-06
SEA MEDICAL PRODUCTS LO-VOL (K811847)Sea Medical Products, Inc.1981-07-13
SAFEED EXTENSION TUBES (K810005)Terumo Medical Corp.1981-02-05
CLEAR PLASTIC CONNECTING TUBES (K800879)Harvard Laboratories1980-06-17
ANESTHESIA EXTENSION TUBES (K800877)Harvard Laboratories1980-06-17
EXTENSION SET QUEST CODE #3000 (K800825)Quest Medical, Inc.1980-05-14
MEDICAL GRADE SILICONE ELASTOMER TUBING (K781087)Mcghan Medical Corp.1978-11-22
CENTRAL CATHETER KIT (K780673)Argon Medical Corp.1978-05-16
NASAL GASTRIC TUBE RETAINER (K780396)Mor-Mac, Inc.1978-03-22
TIME WATCH (K772119)Akzona, Inc.1977-11-14
BLOOD COLLECTION SET TYPE H (K771269)Berman, Pcp & Consultants, Inc.1977-09-12
MONITORING LINES & FLUID ADMIN. (K771387)Norton Performance Plastics Corp.1977-08-22
POUCH, TYVEK-POLYMYLON (K770945)Medical Disposables Intl., Inc.1977-06-29
CONNECTORS (K770596)Abco Dealers, Inc.1977-06-20
LUER-LOCK EXTENSION SET (K770174)American Viggo1977-03-30
TUBE HOLDING DEVICE (K770108)Pharmaseal Div., Baxter Healthcare Corp.1977-03-10

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