Cleared Traditional

K955782 - MED-NET STOPCOCKS

K955782 is an FDA 510(k) clearance for MED-NET STOPCOCKS, manufactured by Mednet, Inc.. The device is a Class 2 General Hospital device with product code FMG cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K955782 · Mednet, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1996
Decision
62d
Days
Class 2
Risk

K955782 is an FDA 510(k) clearance for the MED-NET STOPCOCKS. Classified as Stopcock, I.v. Set (product code FMG), Class II - Special Controls.

Submitted by Mednet, Inc. (Sunland, US). The FDA issued a Cleared decision on February 21, 1996 after a review of 62 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 Mednet, Inc. devices

FDA 510(k) Submission Details - K955782

510(k) Number K955782 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 1995
Decision Date February 21, 1996
Days to Decision 62 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 129d · This submission: 62d
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 57
Devices cleared under the same product code (FMG) and FDA review panel - the closest regulatory comparables to K955782.
TRI-FLOW THREE WAY STOPCOCK
K961982 · North, Inc. · Feb 1997
STOPCOCK MANIFOLD GANGS
K962581 · Baxter Healthcare Corp · Aug 1996
STOPCOCK & LUER LOCK PLUG
K954970 · Medex, Inc. · Apr 1996
MINIBORE STOPCOCK SET
K954984 · Distronic Sterile Products, Inc. · Jan 1996
ICU STOPCOK WITH EXTENSION TUBING
K953573 · Icu Medical, Inc. · Oct 1995
STOPCOCK INTRAVENOUS THERAPY
K940070 · Puritas Health Care, Inc. · Apr 1994