Cleared Traditional

K910550 - CONDOMS/SAXON, GOLD CIRCLE COIN, EMBRACE & RAINBOW

K910550 is an FDA 510(k) clearance for CONDOMS/SAXON, 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 116-day FDA review.

K910550 · Safetex Corp. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1991
Decision
116d
Days
Class 2
Risk

K910550 is an FDA 510(k) clearance for the CONDOMS/SAXON, GOLD CIRCLE COIN, EMBRACE & RAINBOW. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Safetex Corp. (Colonial Heights, US). The FDA issued a Cleared decision on June 3, 1991 after a review of 116 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 Safetex Corp. devices

FDA 510(k) Submission Details - K910550

510(k) Number K910550 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 1991
Decision Date June 03, 1991
Days to Decision 116 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 160d · This submission: 116d
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 K910550.
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
TROJAN(R) EXTRA STR LATEX CONDOM W/SPERM SILI LUBR
K904000 · Armkel, LLC · Feb 1991