Cleared Traditional

K953583 - LUBRICATED CONDOM

K953583 is an FDA 510(k) clearance for LUBRICATED CONDOM, manufactured by Tactyl Technologies, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Traditional 510(k) pathway after a 178-day FDA review.

K953583 · Tactyl Technologies, Inc. · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
Jan 1996
Decision
178d
Days
Class 2
Risk

K953583 is an FDA 510(k) clearance for the LUBRICATED CONDOM. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Tactyl Technologies, Inc. (Vista, US). The FDA issued a Cleared decision on January 26, 1996 after a review of 178 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 Tactyl Technologies, Inc. devices

FDA 510(k) Submission Details - K953583

510(k) Number K953583 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 1995
Decision Date January 26, 1996
Days to Decision 178 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
18d slower than avg
Panel avg: 160d · This submission: 178d
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 146
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K953583.
K-Y PERSONAL LUBRICANT
K955648 · Ortho Pharmaceutical Corp. · Jun 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
CONQUEROR, RUMBA AND TEMPTATION
K946207 · Frontline Latex Products Pvt. , Ltd. · Jan 1996
SEMINAL FLUID COLLECTION KIT II
K954791 · Apex Medical Technologies, Inc. · Jan 1996
SPERMICIDALLY LUBRICATED CONDOM
K940047 · Ansell, Inc. · Dec 1995