Cleared Traditional

K880463 - CONDOM (PROPHYLACTIC)

K880463 is an FDA 510(k) clearance for CONDOM (PROPHYLACTIC), manufactured by Health Technologies Intl.. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Traditional 510(k) pathway after a 131-day FDA review.

K880463 · Health Technologies Intl. · Obstetrics & Gynecology device
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Jun 1988
Decision
131d
Days
Class 2
Risk

K880463 is an FDA 510(k) clearance for the CONDOM (PROPHYLACTIC). Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Health Technologies Intl. (Seattle, US). The FDA issued a Cleared decision on June 13, 1988 after a review of 131 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.

FDA 510(k) Submission Details - K880463

510(k) Number K880463 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 1988
Decision Date June 13, 1988
Days to Decision 131 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
30d faster than avg
Panel avg: 161d · This submission: 131d
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 347
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K880463.
SENSATIONS BRAND CONDOMS
K871358 · Apex Medical Technologies, Inc. · Mar 1989
TROJAN EXTRA STRENGTH LUBRICATED
K883413 · Carter Products · Dec 1988
KISS OF MINT(TM) NON-LUBRICATED CONDOM
K882389 · Ansell, Inc. · Oct 1988
BLAUSIEGEL TRANSPARENT CONDOMS
K871267 · Ticosan, Inc. · Apr 1988
CONDOMS (HOMBRE BLACK/BLACK SATIN/XT-12/ORION)
K872356 · Mayer Laboratories · Apr 1988
CONTATTO CONDOMS
K871744 · Razi Corp. · Mar 1988
K880463 · CONDOM (PROPHYLACTIC)
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