Cleared Traditional

K955648 - K-Y PERSONAL LUBRICANT

K955648 is an FDA 510(k) clearance for K-Y PERSONAL LUBRICANT, manufactured by Ortho Pharmaceutical Corp.. The device is a Class 2 Obstetrics & Gynecology device with 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

FDA 510(k) Submission Details - K955648

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
Combination Product No
PCCP Authorized No
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.

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 197
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K955648.
LOVING SMARTER - SAFER SEX
K963679 · Loving Smarter, Inc. · Dec 1996
CONDOM
K960710 · Polar Latex , Ltd. · Oct 1996
TRUSTEX FLAVOR CONDON IN COLORS
K946103 · Line One Laboratories & Trading Co. · Jul 1996
RIA LATEX CONDOM, NONOXYNOL-9
K945145 · Mbf Personal Care Sdn. Bhd. · Feb 1996
RIA LATEX CONDOM
K943880 · Mbf Personal Care Sdn. Bhd. · Feb 1996
LUBRICATED CONDOM
K953583 · Tactyl Technologies, Inc. · Jan 1996