Cleared Traditional

K955648 - K-Y PERSONAL LUBRICANT

K955648 is the FDA 510(k) clearance for K-Y PERSONAL LUBRICANT by Ortho Pharmaceutical Corp.. It is a Class 2 Obstetrics & Gynecology device (product code HIS) cleared through the Traditional 510(k) pathway after a 192-day FDA review.

K955648 · Ortho Pharmaceutical Corp. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1996
Decision
192d
Days
Class 2
Risk

K955648 is an FDA 510(k) clearance for the K-Y PERSONAL LUBRICANT. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Ortho Pharmaceutical Corp. (Raritan, US). The FDA issued a Cleared decision on June 21, 1996 after a review of 192 days - an extended review 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: 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 Ortho Pharmaceutical Corp. devices

Submission Details

510(k) Number K955648 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 1995
Decision Date June 21, 1996
Days to Decision 192 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d slower than avg
Panel avg: 160d · This submission: 192d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 37
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K955648.
TROJAN MINT TINGLE BRAND LATEX CONDOMS
K023405 · Armkel, LLC · Dec 2002
TROJAN EXTRA LARGE LATEX CONDOM
K001212 · Armkel, LLC · May 2000
TROJAN LATEX CONDOM WITH MALE GENITAL DESENSITIZER LUBRICANT
K000748 · Armkel, LLC · Apr 2000
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
MAGNUM PLUS LATEX CONDOM W/SPERMICIDAL LUBRICANT
K895640 · Armkel, LLC · Jan 1990