Cleared Traditional

K842173 - DISPOSABLE STOPCOCKS

K842173 is the FDA 510(k) clearance for DISPOSABLE STOPCOCKS by Procedure Products, Inc.. It is a Class 2 General Hospital device (product code FMG) cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K842173 · Procedure Products, Inc. · General Hospital
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Sep 1984
Decision
113d
Days
Class 2
Risk

K842173 is an FDA 510(k) clearance for the DISPOSABLE STOPCOCKS. Classified as Stopcock, I.v. Set (product code FMG), Class II - Special Controls.

Submitted by Procedure Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 5, 1984 after a review of 113 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Procedure Products, Inc. devices

Submission Details

510(k) Number K842173 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 1984
Decision Date September 05, 1984
Days to Decision 113 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
16d faster than avg
Panel avg: 129d · This submission: 113d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 31
Devices cleared under the same product code (FMG) and FDA review panel - the closest regulatory comparables to K842173.
VIGGO EXACTA PRESSURE MONITORING KIT
K864900 · Ohmeda Medical · Apr 1987
VIGGO EXACTA PRESSURE MONITORING SYSTEM
K870261 · Ohmeda Medical · Apr 1987
CLICK LOCK MULTI-VAS INFECTION CONTROL MANIFOLD
K853275 · Icu Medical, Inc. · Aug 1985
STOPCOCKS & EXTENSION TUBES
K840394 · American Pharmaseal Div. Ahsc · Mar 1984
PEDIATRIC EXTEN. SET FOR SECOND-DRUG
K830198 · Travenol Laboratories, S.A. · Feb 1983
TERUFUSION THREE-WAY STOPCOCK
K823469 · Terumo Medical Corp. · Dec 1982