Cleared Traditional

K842173 - DISPOSABLE STOPCOCKS

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

K842173 · Procedure Products, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K842173

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.

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 54
Devices cleared under the same product code (FMG) and FDA review panel - the closest regulatory comparables to K842173.
EXEL THREE-WAY STOPCOCK
K862492 · Exel Intl. · Sep 1986
CHURCHILL 3-WAY STOPCOCK SET
K854348 · Churchill Corp. · Nov 1985
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