Cleared Traditional

K872326 - GONOSTAT MALE SPECIMEN COLLECTION & TRANSPORT

K872326 is an FDA 510(k) clearance for GONOSTAT MALE SPECIMEN COLLECTION & TRA..., manufactured by Technology Management & Marketing, Inc.. The device is a Class 1 Microbiology device with product code JTW cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K872326 · Technology Management & Marketing, Inc. · Microbiology device
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Aug 1987
Decision
55d
Days
Class 1
Risk

K872326 is an FDA 510(k) clearance for the GONOSTAT MALE SPECIMEN COLLECTION & TRANSPORT. Classified as System, Transport, Aerobic (product code JTW), Class I - General Controls.

Submitted by Technology Management & Marketing, Inc. (Chicago, US). The FDA issued a Cleared decision on August 11, 1987 after a review of 55 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2900 - the FDA microbiology 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 Technology Management & Marketing, Inc. devices

FDA 510(k) Submission Details - K872326

510(k) Number K872326 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 1987
Decision Date August 11, 1987
Days to Decision 55 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 102d · This submission: 55d
Pathway characteristics
Predicate-based equivalence.

JTW Device Classification - Class 1, General Controls

Product Code JTW System, Transport, Aerobic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2900
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JTW System, Transport, Aerobic

All 30
Devices cleared under the same product code (JTW) and FDA review panel - the closest regulatory comparables to K872326.
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