Cleared Traditional

K922889 - CONDOOM SHELF LIFE -- MODIFICATIONS

K922889 is an FDA 510(k) clearance for CONDOOM SHELF LIFE -- MODIFICATIONS, manufactured by Safetex Corp.. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Traditional 510(k) pathway after a 467-day FDA review.

K922889 · Safetex Corp. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1993
Decision
467d
Days
Class 2
Risk

K922889 is an FDA 510(k) clearance for the CONDOOM SHELF LIFE -- MODIFICATIONS. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Safetex Corp. (Colonial Heights, US). The FDA issued a Cleared decision on September 1, 1993 after a review of 467 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Obstetrics & Gynecology submissions.

View all Safetex Corp. devices

FDA 510(k) Submission Details - K922889

510(k) Number K922889 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 1992
Decision Date September 01, 1993
Days to Decision 467 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
307d slower than avg
Panel avg: 160d · This submission: 467d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HIS Device Classification - Class 2, Special Controls

Product Code HIS Condom
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.

Regulatory Peers - HIS Condom

All 202
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K922889.
SAXON GOLD ULTRA SPERMICIDAL RAINBOW CONDOM
K943883 · Aladan Corp. · Apr 1995
CONDOM
K940045 · Ansell, Inc. · Jan 1995
NON-LUBRICATED CONDOM
K940046 · Ansell, Inc. · Jan 1995
TROJAN (TM-TBD) CONDOM
K912901 · Carter Products · Feb 1992
MCLAUGHLIN LAPAROSCOPIC GRASPER
K910578 · Marlo Surgical Technology · Apr 1991
TROJAN NATURALAMB NATURAL MEMBRANE CONDOM W/SPERM.
K902305 · Armkel, LLC · Mar 1991