Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
DTL — Predicate Candidate Screening
137 FDA 510(k) clearances under this product code; the 50 most recent screened below.
78 daysmedian FDA review time
166 days90th percentile
137clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K152528 | Attachable Cath Lab Hemostasis Valve | Galt Medical Corp. | 2015-12-02 | 90 | 0 |
| K143429 | Passage Hemostasis Valve | Merit Medical Systems, Inc. | 2014-12-22 | 21 | 0 |
| K140475 | ROTATING ADAPTERS | Merit Medical Systems, Inc. | 2014-04-16 | 49 | 0 |
| K131124 | COLIGN | Jilin Coronado Medical , Ltd. | 2013-08-28 | 128 | 0 |
| K123448 | AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH BALANCE BIOSURFACE, | Medtronic, Inc. | 2012-12-13 | 35 | 0 |
| K122811 | CONNECTOR COMPONENTS WITH BALANCE BIOSURFACE | Medtronic, Inc. | 2012-10-12 | 29 | 1 |
| K122301 | GUARDIAN II HEMOSTASIS VALVE GUARDIAN II NC HEMOSTASIS VALVE | Vascular Solutions Zerusa , Ltd. | 2012-09-07 | 37 | 2 |
| K120069 | MEDLINE STOPCOCK AND MANIFOLD | Medline Industries, Inc. | 2012-04-03 | 85 | 0 |
| K113148 | E-PASS | Synexmed(Shenzhen)Company Limited | 2012-02-28 | 127 | 0 |
| K113845 | TUBING, CONMNECTORS, AND ACCESSORIES WIT BALANCE BIOSURFACE | Medtronic, Inc. | 2012-01-25 | 28 | 1 |
| K113132 | DISPOSABLE HEMOSTATIC Y-CONNECTORS | Coeur, Inc. | 2012-01-20 | 88 | 0 |
| K113667 | CARDIOPLEGIA DELIVERY SETS CARDIOPLEGIA DELIVERY SETS WITH D | Edwards Lifesciences, LLC | 2012-01-12 | 30 | 0 |
| K101113 | GUARDIAN II NC HEMOSTASIS VALVE | Zerusa Limited | 2010-05-21 | 30 | 2 |
| K093992 | TERUMO LAUER LOCK ADAPTER | Terumo Cardiovascular Systems Corporation | 2010-05-19 | 146 | 0 |
| K100319 | MERIT MANIFOLD WITH INTEGRATED TRANSDUCER, MODEL 203LTCHN-R; | Merit Medical Systems, Inc. | 2010-04-28 | 83 | 0 |
| K091634 | NMI FC | Navilyst Medical, Inc. | 2010-03-01 | 270 | 0 |
| K092563 | GATOR CLIPSEAL PLUG | Vascular Solutions, Inc. | 2009-11-04 | 76 | 0 |
| K092711 | GUARDIAN II HEMOSTASIS VALVE | Zerusa Limited | 2009-10-01 | 28 | 2 |
| K080472 | SEDAT MYSHELL LITE | Sedat | 2008-04-23 | 62 | 0 |
| K073260 | LIISA LEVER INTEGRATED INTERVENTIONAL SYSTEM ADAPTER, MODEL | Device Partners International | 2008-03-13 | 114 | 0 |
| K073474 | CAPIOX CIRCUIT CONNECTORS | Terumo Corp. | 2008-03-05 | 85 | 0 |
| K073620 | GUARDIAN HEMOSTASIS VALVE | Zerusa Limited | 2008-02-27 | 63 | 0 |
| K072745 | Y-GLIDE | Thomas Medical Products, Inc. | 2008-01-04 | 99 | 2 |
| K072556 | HEMOSTASIS VALVE | Merit Medical Systems, Inc. | 2007-11-20 | 71 | 0 |
| K060759 | Y-CLICK CONNECTOR | Elcam Medical Acal | 2006-06-29 | 100 | 0 |
| K052459 | 6248VAL ADJUSTABLE VALVE | Medtronic Vascular | 2006-01-11 | 126 | 1 |
| K052381 | GUARDIAN HEMOSTASIS VALVE WITH GUIDEWIRE INTRODUCER | Zerusa Limited | 2005-11-21 | 83 | 0 |
| K042060 | EASYPASS US Y-CONNECTOR HEMOSTATIC VALVE | Millimed A/S | 2004-10-06 | 68 | 0 |
| K041697 | TERUMO CIRCUIT CONNECTORS | Terumo Cardiovascular Systems Corporation | 2004-08-11 | 50 | 0 |
| K040498 | MYSHELL | Sedat S.A. | 2004-07-02 | 127 | 0 |
| K033328 | NOVOSCI TUBING AND CONNECTORS WITH NOVOCOAT TREATMENT | Novosci Corp. | 2004-01-16 | 92 | 0 |
| K031688 | RAPIDO CUT-A-WAY ROTATING HEMOSTASIS VALVE | Guidant Corporation | 2003-07-02 | 30 | 1 |
| K031398 | IS-1 HEMOSTASIS VALVE, MODEL 6799 | Guidant Corp. | 2003-05-20 | 15 | 0 |
| K030077 | GISH TUBING AND CONNECTORS WITH GBS COATING | Gish Biomedical, Inc. | 2003-03-14 | 65 | 0 |
| K022918 | ADAPTERS WITH X-COATING | Terumo Cardiovascular Systems Corporation | 2002-11-27 | 84 | 0 |
| K021282 | LV-1 HEMOSTASIS VALVE, MODEL #6789 | Guidant Corp. | 2002-05-02 | 14 | 0 |
| K003604 | ADAPTERS WITH X-COATING | Terumo Cardiovascular Systems Corp. | 2001-02-07 | 78 | 0 |
| K992906 | COMPONENTS FOR CARDIOVASCULAR PROCEDURE KIT | Olson Medical Sales, Inc. | 1999-11-10 | 72 | 0 |
| K993057 | MBA | Merit Medical Systems, Inc. | 1999-10-05 | 22 | 0 |
| K991102 | COPILOT BLEEDBACK CONTROL VALVE, MODEL 1003331 | Guidant Corp. | 1999-06-09 | 69 | 1 |
| K972654 | MANIFOLD | Medical Specialties Intl., Inc. | 1997-10-08 | 85 | 0 |
| K963749 | HIGH PRESSURE INJECTION LINES | Maxxim Medical | 1996-12-17 | 90 | 0 |
| K961181 | NMI VEIN GRAFT PERFUSION SET | Naltiac Medical, Inc. | 1996-06-21 | 87 | 0 |
| K955554 | HEMO-VALVE | North American Instrument Corp. | 1996-03-04 | 90 | 0 |
| K954284 | MEDI-PLAST 2 PORT MANIFOLD (RIGHT ON) | Medi-Plast Intl., Inc. | 1996-02-12 | 166 | 0 |
| K953564 | MEDTRONIC OVERPRESSURE/VACUUM RELIEF VALVE | Medtronic Cardiac Surgery, Medtronic, Inc. | 1996-02-02 | 186 | 0 |
| K952531 | QUEST VEIN GRAFT PERFUSION SET | Quest Medical, Inc. | 1995-08-24 | 84 | 0 |
| K942391 | BRAUN MANIFOLD | B.Braun Medical, Inc. | 1995-06-21 | 398 | 0 |
| K951089 | SCIMED GATEWAY PLUS | Scimed Life Systems, Inc. | 1995-05-31 | 83 | 0 |
| K945931 | RMI CIRKUIT-GUARD(TM) PRESSURE RELIEF VALVE | Research Industries Corp. | 1995-03-03 | 88 | 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