Cleared Traditional

K954337 - GENOTROPIN MIXER

K954337 is the FDA 510(k) clearance for GENOTROPIN MIXER by Pharmacia, Inc.. It is a Class 2 General Hospital device (product code FMF) cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K954337 · Pharmacia, Inc. · General Hospital
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Optimized for regulatory review, auditing and printing
Nov 1995
Decision
56d
Days
Class 2
Risk

K954337 is an FDA 510(k) clearance for the GENOTROPIN MIXER. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Pharmacia, Inc. (Columbus, US). The FDA issued a Cleared decision on November 13, 1995 after a review of 56 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - 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 Pharmacia, Inc. devices

Submission Details

510(k) Number K954337 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 1995
Decision Date November 13, 1995
Days to Decision 56 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
73d faster than avg
Panel avg: 129d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FMF Syringe, Piston
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
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 - FMF Syringe, Piston

All 285
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K954337.
B-D E ML PEN
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TERUMO RETRACTABLE NEEDLE (RN) SYRINGE
K953940 · Terumo Medical Corp. · May 1996
BECTON DICKINSON SYRINGSE
K954064 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Nov 1995
B-D PEN ULTRA
K951919 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1995
PISTON SYRINGE
K951025 · Pharmacia, Inc. · Oct 1995
PTFE SYRINGE FILTER
K952918 · B.Braun Medical, Inc. · Sep 1995