Cleared Traditional

K864400 - EXTRA STRONG CONDOM

K864400 is an FDA 510(k) clearance for EXTRA STRONG CONDOM, manufactured by Ansell, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K864400 · Ansell, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1987
Decision
88d
Days
Class 2
Risk

K864400 is an FDA 510(k) clearance for the EXTRA STRONG CONDOM. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Ansell, Inc. (Dothan, US). The FDA issued a Cleared decision on February 2, 1987 after a review of 88 days - a notably fast clearance cycle.

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: 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 Ansell, Inc. devices

FDA 510(k) Submission Details - K864400

510(k) Number K864400 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 1986
Decision Date February 02, 1987
Days to Decision 88 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 160d · This submission: 88d
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 196
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K864400.
TROJAN EXTRA STRENGTH LUBRICATED
K883413 · Carter Products · Dec 1988
KISS OF MINT(TM) NON-LUBRICATED CONDOM
K882389 · Ansell, Inc. · Oct 1988
LIFESTYLES EXTRA STRENGTH CONDOMS W/NONOXYNOL-9
K871304 · Ansell, Inc. · Jun 1987
PRIME
K830691 · Ansell, Inc. · Mar 1983
NUDA-PLUS CONDOM W/SPERMICIDAL LUBRICANT
K822792 · Ansell, Inc. · Sep 1982