Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FPK — Predicate Candidate Screening
64 FDA 510(k) clearances under this product code; the 50 most recent screened below.
61 daysmedian FDA review time
207 days90th percentile
64clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K131517 | MEDRAD TWIST & GO HIGH PRESSURE CONNECTOR TUBING | Medrad, Inc. / Bayer Medical Care, Inc. | 2013-08-02 | 66 | 0 |
| K063114 | DISPOSABLE TRANSFER SETS WITH AND WITHOUT SWABBABLE VALVES A | Coeur, Inc. | 2007-02-09 | 121 | 0 |
| K063239 | LIFESHIELD LATEX-FREE GRAVITECH FLOW CONTROLLER I.V. SETS, M | Hospira, Inc. | 2006-12-11 | 46 | 7 |
| K052431 | MEDTRONIC MINIMED LEAPFROG II INFUSION SET, MODELS MMT-801S1 | Medtronic Minimed | 2005-11-29 | 84 | 0 |
| K041178 | EMPOWER TRANSFER SET, (CAT. NO. 7725) | E-Z-Em, Inc. | 2004-07-16 | 72 | 0 |
| K031808 | MEDRAD SWABBABLE VALVE TRANSFER SET | Medrad, Inc. | 2003-07-11 | 29 | 0 |
| K022431 | MEDRAD TRANSFER SET | Medrad, Inc. | 2002-09-05 | 42 | 0 |
| K965208 | POLYFIN EXTENSION SET, MODELS 126 AND 128 | Medtronic Minimed | 1997-02-26 | 61 | 0 |
| K953864 | SILCLEAR TUBING (MODIFICATION) | Degania Silicone , Ltd. | 1995-11-06 | 91 | 0 |
| K950508 | SYSMEX SF-3000 | Sysmex Corp. | 1995-11-03 | 270 | 0 |
| K952243 | EXTENSION SET/I.V. SET | Coast Medical, Inc. | 1995-07-26 | 75 | 0 |
| K952663 | 60 MICRO VOLUME EXTENSION SET W/.22 MICRON FILTER, 21 EXTENS | Distronic Sterile Products, Inc. | 1995-07-14 | 32 | 0 |
| K950861 | RECONSTITUTION ACCESSOREIS | Organon, Inc. | 1995-05-26 | 88 | 0 |
| K933524 | EXTENTION SET | Mediziv Medical Products 1987 , Ltd. | 1995-05-23 | 672 | 0 |
| K950200 | IVID | Scott/Ross Designs, Inc. | 1995-03-24 | 65 | 0 |
| K943992 | SILCLEAR TUBING | Degania Silicone , Ltd. | 1995-03-16 | 212 | 0 |
| K943206 | VARIOUS TUBING | Prn Services, Inc. | 1995-03-09 | 247 | 0 |
| K945184 | INTRAVASCULAR ADMINISTRATION SET | Distronic Sterile Products, Inc. | 1995-02-08 | 107 | 0 |
| K941214 | LIFESHIELD EXTENSION SET | Abbott Mfg., Inc. | 1994-10-03 | 207 | 10 |
| K935642 | EVANS MEDICAL EXTENSION SETS | Evans Medical, Inc. | 1994-01-28 | 67 | 1 |
| K921450 | NON-INVASIVE TUBING | Specialty Medical Sales, Inc. | 1993-02-05 | 316 | 0 |
| K923972 | OPHTHALMIC FLUID DISTRIBUTION SETS | Visitec Co. | 1992-11-04 | 89 | 0 |
| K915560 | LO-PROFILE EXTENSION SET | Douglas Medical Products Corp. | 1992-05-14 | 155 | 0 |
| K912103 | LIFESHIELD EXTENSION SET | Abbott Laboratories | 1991-12-13 | 214 | 2 |
| K910906 | CENTURION KLEEN-NEEDLE SYSTEM I.V. EXTENSION SETS | Tri-State Hospital Supply Corp. | 1991-04-01 | 27 | 0 |
| K891009 | INTRAVASCULAR ADMINISTRATION SET MODEL 60040 | 3M Company | 1989-05-16 | 77 | 0 |
| K891005 | INTRAVASCULAR ADMINI. SET MODELS 60030 & 60050 | 3M Company | 1989-05-11 | 72 | 0 |
| K883718 | MERIT HI-FLEX(TM) | Merit Medical Systems, Inc. | 1989-01-30 | 152 | 5 |
| K884156 | HYPERBARIC INTRAVENOUS INFUSION EXTENSION SET | Sechrist Industries, Inc. | 1988-11-14 | 41 | 0 |
| K884370 | CMS IV EXTENSION SETS | Churchill Medical Systems, Inc. | 1988-11-07 | 20 | 0 |
| K875186 | IV EXTENSION SET | Marquette Medical, Inc. | 1988-02-16 | 56 | 0 |
| K873465 | VAN DELLEN BACTERIA FILTER | Van Dellen, Ltd. | 1988-01-20 | 145 | 0 |
| K873852 | INFUSION MANIFOLD | Advanced Surgical Products, Inc. | 1987-11-23 | 62 | 0 |
| K874360 | PLASTIC TUBING CONNECTOR | American Medical Technology, Inc. | 1987-11-17 | 25 | 0 |
| K871085 | EXTENSION TUBE PUMP SET | Churchill Corp. | 1987-06-15 | 89 | 0 |
| K871540 | SWIVEL CONNECTORS #014452/#014453/#014459-120 | Clinical Connections, Inc. | 1987-04-30 | 23 | 0 |
| K870416 | LP EXTENSION SETS | North Coast Medi-Tek | 1987-04-06 | 62 | 0 |
| K870912 | T-CONNECTORS 014500/014501/014502/014503-120 | Clinical Connections, Inc. | 1987-03-17 | 11 | 0 |
| K870326 | VARIOUS LUER AND TUBING FITTINGS | Clinical Connections, Inc. | 1987-02-10 | 13 | 0 |
| K864692 | EXTENSION SETS | Salt Creek Medical Technologies | 1986-12-18 | 16 | 0 |
| K864395 | LOW VOLUME EXTENSION SET | Panamedix, Inc. | 1986-12-16 | 40 | 0 |
| K861626 | CHURCHILL EXTENSION TUBE | Churchill Corp. | 1986-06-02 | 41 | 0 |
| K854629 | CHURCHILL-H EXTENSION TUBE | Churchill Corp. | 1985-12-10 | 22 | 0 |
| K834164 | SPINAL NEEDLES & ACCESSORY | Elfa Trading Co. | 1983-12-13 | 12 | 0 |
| K833659 | IV EXTENSION SET | Dna Medical, Inc. | 1983-11-29 | 42 | 0 |
| K833076 | C-FLEX MEDICAL GRADE TUBING | Concept, Inc. | 1983-11-21 | 73 | 0 |
| K832758 | RED COLOR-TINTED TUBING | Custom Medical, Inc. | 1983-09-12 | 24 | 0 |
| K820527 | ANESTHESIA EXTENSION TUBES | David Simmonds Co., Inc. | 1982-03-18 | 17 | 0 |
| K812981 | FLUVEN SETS (EXT-1, EXT-2, EXT-3, EXT-4) | Venusa , Ltd. | 1981-11-06 | 14 | 0 |
| K811847 | SEA MEDICAL PRODUCTS LO-VOL | Sea Medical Products, Inc. | 1981-07-13 | 12 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda