Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FMG — Predicate Candidate Screening
89 FDA 510(k) clearances under this product code; the 50 most recent screened below.
68 daysmedian FDA review time
232 days90th percentile
89clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K242255 | Qitexio® 4-Way Stopcock (QIT014) | Medex | 2025-04-29 | 272 | 0 |
| K223499 | Three Way Stop Cock | M/S Romsons International | 2023-07-21 | 242 | 0 |
| K223175 | lntravascular Administration Sets with Stopcock and Manifold | Baxter Healthcare Corporation | 2023-03-10 | 150 | 0 |
| K211204 | SafePort(TM) Manifold (or Stopcock) | Elcam Medical Acal | 2022-09-15 | 511 | 0 |
| K210516 | Clicky Cross | Yomura Technologies, Inc. | 2022-05-16 | 447 | 0 |
| K190539 | TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non | Monumedical, LLC | 2019-10-22 | 232 | 0 |
| K190489 | Elcam Stopcocks and Manifolds | Elcam Medical Acal | 2019-04-23 | 54 | 0 |
| K172266 | Dynarex Three-Way Stopcock | Dynarex Corporation | 2018-03-14 | 230 | 0 |
| K141254 | ELCAM STOPCOCKS AND MANIFOLDS | Elcam Medical Acal | 2014-07-30 | 77 | 0 |
| K123084 | DISPOSABLE HIGH PRESSURE STOPCOCK/MANIFOLD MODEL HP STOPCOCK | Elcam Medical Acal | 2013-05-23 | 234 | 0 |
| K130245 | LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE | Baxter Healthcare Corp | 2013-03-01 | 29 | 1 |
| K082110 | DUAL SYRINGE HOLDER | Surgin Surgical Instrumentation, Inc. | 2009-06-17 | 324 | 0 |
| K082836 | ICU MEDICAL UNIVERSAL SINGLE-USE SPIKES | Icu Medical, Inc. | 2009-02-25 | 152 | 0 |
| K082106 | ELCAM ANTIMICROBIAL CLOSED STOPCOCKS (DSS AND TSS) | Elcam Medical Acal | 2008-10-02 | 69 | 0 |
| K080077 | CLAVE STOPCOCK | Icu Medical, Inc. | 2008-02-13 | 33 | 0 |
| K071400 | SMARTSITE STOPCOCK | Cardinal Health, Alaris Products | 2007-12-14 | 207 | 0 |
| K070143 | JMS PLANECTA STOPCOCK | Jms North America Corp. | 2007-04-10 | 84 | 0 |
| K053405 | BACSTOP | Elcam Medical Acal | 2006-05-11 | 155 | 0 |
| K061143 | ROBERTSITE STOPCOCK | Halkey-Roberts Corp. | 2006-05-10 | 15 | 0 |
| K060231 | CLOSED SWABABLE STOPCOCK AND MINIMAL RESIDUAL VOLUME LUER-AC | Elcam Medical Acal | 2006-04-13 | 73 | 17 |
| K052330 | TRU-SWAB STOCOCK | Medegen Medical Manufacturing Services | 2005-09-09 | 14 | 0 |
| K041779 | NIPRO DISPOSABLE STOPCOCKS, MODELS 3W-RC. NCN-3, 3W-R, 3W-L | Nipro Medical Corp. | 2004-09-21 | 82 | 0 |
| K032393 | INDUCTION AND SAMPLING MANIFOLD (OR STOPCOCK) | Elcam Medical Acal | 2003-09-12 | 39 | 2 |
| K022895 | ELCAM STOPCOCKS AND MANIFOLDS | Medical Device Consultants, Inc. | 2002-10-18 | 45 | 12 |
| K012157 | CHURCHILL MEDICAL SYSTEMS STOPCOCK | Churchill Medical Systems, Inc. | 2001-09-11 | 62 | 0 |
| K010217 | 4 PORT, 4 WAY STOPCOCK | George Loo, MD | 2001-03-18 | 53 | 0 |
| K982368 | MANIFOLD WITH EXTENSION SET | Interpore Cross Intl. | 1998-07-31 | 24 | 0 |
| K974083 | CONNECTA PLUS 1 AND CONNECTA PLUS 3 2-WAY AND 3-WAY STOPCOCK | Ohmeda Medical | 1998-01-13 | 76 | 2 |
| K964435 | PRIMARY IV SET | Icu Medical, Inc. | 1997-04-02 | 148 | 25 |
| K961982 | TRI-FLOW THREE WAY STOPCOCK | North, Inc. | 1997-02-21 | 277 | 0 |
| K962581 | STOPCOCK MANIFOLD GANGS | Baxter Healthcare Corp | 1996-08-28 | 58 | 14 |
| K954970 | STOPCOCK & LUER LOCK PLUG | Medex, Inc. | 1996-04-22 | 175 | 1 |
| K955782 | MED-NET STOPCOCKS | Mednet, Inc. | 1996-02-21 | 62 | 0 |
| K954984 | MINIBORE STOPCOCK SET | Distronic Sterile Products, Inc. | 1996-01-23 | 84 | 0 |
| K953573 | ICU STOPCOK WITH EXTENSION TUBING | Icu Medical, Inc. | 1995-10-07 | 68 | 0 |
| K940070 | STOPCOCK INTRAVENOUS THERAPY | Puritas Health Care, Inc. | 1994-04-04 | 88 | 0 |
| K932512 | MULTI-PORT MANIFOLD | Baxter Healthcare Corp | 1994-02-22 | 273 | 3 |
| K913560 | STOPCOCK | Graham Medical Products | 1991-12-31 | 144 | 0 |
| K911415 | TRUMPET VALVE | B. Braun of America, Inc. | 1991-06-03 | 63 | 0 |
| K902724 | ADVANCE DISPOSABLE STOPCOCK | Advance Medical Designs, Inc. | 1990-12-05 | 167 | 0 |
| K891234 | TERUFUSION THREE WAY STOPCOCK | Terumo Medical Corp. | 1989-09-19 | 196 | 0 |
| K884463 | CONNECTA MONOFLO & MULTIFLO INFUSION CONNECTORS | Ohmeda Medical | 1989-01-09 | 77 | 0 |
| K884435 | RESUBMITTED 1,3 & 4 WAY STOPCOCKS, VARIOUS PARTS | Clinical Connections, Inc. | 1988-11-08 | 26 | 0 |
| K881805 | TU STOPCOCK | Tulan Corp. C/O Richard Hamer Assoc. | 1988-10-04 | 159 | 0 |
| K872067 | STERICAP ASSEMBLY AND REPLACEMENT TRAY | Stericap Systems | 1987-08-04 | 67 | 0 |
| K872066 | STERICAP STOPCOCK | Stericap Systems | 1987-08-04 | 67 | 0 |
| K864900 | VIGGO EXACTA PRESSURE MONITORING KIT | Ohmeda Medical | 1987-04-01 | 107 | 0 |
| K870261 | VIGGO EXACTA PRESSURE MONITORING SYSTEM | Ohmeda Medical | 1987-04-01 | 107 | 0 |
| K870324 | #014460-120 3-WAY & #014461-120 4-WAY STOPCOCK | Clinical Connections, Inc. | 1987-03-13 | 44 | 0 |
| K864440 | CHURCHILL 3-WAY STOPCOCK | Churchill Corp. | 1987-01-20 | 69 | 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