Cleared Traditional

K942697 - TROJAN POLYURETHANE CONDOM

K942697 is an FDA 510(k) clearance for TROJAN POLYURETHANE CONDOM, manufactured by Carter Products. The device is a Class 2 Obstetrics & Gynecology device with product code MOL cleared through the Traditional 510(k) pathway after a 379-day FDA review.

K942697 · Carter Products · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1995
Decision
379d
Days
Class 2
Risk

K942697 is an FDA 510(k) clearance for the TROJAN POLYURETHANE CONDOM. Classified as Condom, Synthetic (product code MOL), Class II - Special Controls.

Submitted by Carter Products (Cranbury, US). The FDA issued a Cleared decision on June 22, 1995 after a review of 379 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5300 - the FDA obstetrics and gynecology 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Carter Products devices

FDA 510(k) Submission Details - K942697

510(k) Number K942697 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 1994
Decision Date June 22, 1995
Days to Decision 379 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
219d slower than avg
Panel avg: 160d · This submission: 379d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MOL Device Classification - Class 2, Special Controls

Product Code MOL Condom, Synthetic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.5300
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 Obstetrics & Gynecology devices follow this clearance model.