Atlas FDA

STOPCOCKS

FDA 510(k) clearance K851986 · decided 1985-05-23

Clearance details

K-number
K851986
Device name
STOPCOCKS
Applicant
Transamerica Delaval, Inc.
Decision
Substantially Equivalent
Date received
1985-05-07
Decision date
1985-05-23
Days to decision
16 days
Clearance type
Traditional
Product code
FMG
Device class
2
Regulation number
880.5440
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Pasadena, CA, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Transamerica Delaval

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Qitexio® 4-Way Stopcock (QIT014) (K242255)Medex2025-04-29
Three Way Stop Cock (K223499)M/S Romsons International2023-07-21
lntravascular Administration Sets with Stopcock and Manifold (K223175)Baxter Healthcare Corporation2023-03-10
SafePort(TM) Manifold (or Stopcock) (K211204)Elcam Medical Acal2022-09-15
Clicky Cross (K210516)Yomura Technologies, Inc.2022-05-16
TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSignal Stopcocks with Manifolds Sterile, TurnSignal Stopcocks with Manifolds Bulk Non Sterile (K190539)Monumedical, LLC2019-10-22
Elcam Stopcocks and Manifolds (K190489)Elcam Medical Acal2019-04-23
Dynarex Three-Way Stopcock (K172266)Dynarex Corporation2018-03-14
ELCAM STOPCOCKS AND MANIFOLDS (K141254)Elcam Medical Acal2014-07-30
DISPOSABLE HIGH PRESSURE STOPCOCK/MANIFOLD MODEL HP STOPCOCK, MP STOPCOCK, HP MANIFOLD, PHP MANIFOLD (K123084)Elcam Medical Acal2013-05-23
LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE STOPCOCK WITH EXTENSION SET, GANG LARGE BORE STOPCOCK MANIFO (K130245)Baxter Healthcare Corp2013-03-01
DUAL SYRINGE HOLDER (K082110)Surgin Surgical Instrumentation, Inc.2009-06-17

Recalls involving this device

RecordFirmDate
Portex 3 Way Stopcock Catalog Number: T1102 recall (Z-0234-05)Smiths Medical ASD, Inc.2004-11-24
Portex 3 Way Stopcock Catalog Number: T1103 recall (Z-0235-05)Smiths Medical ASD, Inc.2004-11-24
Portex 3 Way Stopcock Catalog Number: T1202 recall (Z-0236-05)Smiths Medical ASD, Inc.2004-11-24
Portex 3 Way Stopcock Catalog Number: T1203 recall (Z-0237-05)Smiths Medical ASD, Inc.2004-11-24
Portex 4 Way ''T-Handle'' Stopcock Catalog Number: T1204 recall (Z-0238-05)Smiths Medical ASD, Inc.2004-11-24
Portex 4-Way Stopcock Catalog Number: T1206 recall (Z-0239-05)Smiths Medical ASD, Inc.2004-11-24
Portex ULTRA-FLO 4 - Way Stopcock Catalog Number: T1209 recall (Z-0240-05)Smiths Medical ASD, Inc.2004-11-24
Portex ULTRA-FLO 4 Way Stopcock Catalog Number: T1210 recall (Z-0241-05)Smiths Medical ASD, Inc.2004-11-24
Portex High Pressure 1 - Way Stopcock Catalog Number: T8200 recall (Z-0242-05)Smiths Medical ASD, Inc.2004-11-24
Portex High Pressure 4 - Way Stopcock Catalog Number: T8202 recall (Z-0243-05)Smiths Medical ASD, Inc.2004-11-24