Cleared Traditional

K872066 - STERICAP STOPCOCK

K872066 is an FDA 510(k) clearance for STERICAP STOPCOCK, manufactured by Stericap Systems. The device is a Class 2 General Hospital device with product code FMG cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K872066 · Stericap Systems · General Hospital
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Aug 1987
Decision
67d
Days
Class 2
Risk

K872066 is an FDA 510(k) clearance for the STERICAP STOPCOCK. Classified as Stopcock, I.v. Set (product code FMG), Class II - Special Controls.

Submitted by Stericap Systems (New Bern, US). The FDA issued a Cleared decision on August 4, 1987 after a review of 67 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Stericap Systems devices

FDA 510(k) Submission Details - K872066

510(k) Number K872066 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 1987
Decision Date August 04, 1987
Days to Decision 67 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 129d · This submission: 67d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMG Device Classification - Class 2, Special Controls

Product Code FMG Stopcock, I.v. Set
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FMG Stopcock, I.v. Set

All 59
Devices cleared under the same product code (FMG) and FDA review panel - the closest regulatory comparables to K872066.
ADVANCE DISPOSABLE STOPCOCK
K902724 · Advance Medical Designs, Inc. · Dec 1990
TERUFUSION THREE WAY STOPCOCK
K891234 · Terumo Medical Corp. · Sep 1989
CONNECTA MONOFLO & MULTIFLO INFUSION CONNECTORS
K884463 · Ohmeda Medical · Jan 1989
VIGGO EXACTA PRESSURE MONITORING KIT
K864900 · Ohmeda Medical · Apr 1987
VIGGO EXACTA PRESSURE MONITORING SYSTEM
K870261 · Ohmeda Medical · Apr 1987
CHURCHILL 3-WAY STOPCOCK
K864440 · Churchill Corp. · Jan 1987