Cleared Traditional

K971590 - TACTYLON CONDOM

K971590 is an FDA 510(k) clearance for TACTYLON CONDOM, manufactured by Sensicon Corp.. The device is a Class 2 Obstetrics & Gynecology device with product code MOL cleared through the Traditional 510(k) pathway after a 159-day FDA review.

K971590 · Sensicon Corp. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1997
Decision
159d
Days
Class 2
Risk

K971590 is an FDA 510(k) clearance for the TACTYLON CONDOM. Classified as Condom, Synthetic (product code MOL), Class II - Special Controls.

Submitted by Sensicon Corp. (Vista, US). The FDA issued a Cleared decision on October 7, 1997 after a review of 159 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 Sensicon Corp. devices

FDA 510(k) Submission Details - K971590

510(k) Number K971590 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 1997
Decision Date October 07, 1997
Days to Decision 159 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
1d faster than avg
Panel avg: 160d · This submission: 159d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MOL Device Classification - Class 2, Special Controls

Product Code MOL Condom, Synthetic
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 - MOL Condom, Synthetic

All 19
Devices cleared under the same product code (MOL) and FDA review panel - the closest regulatory comparables to K971590.
TROJAN SUPRA LUBRICATED POLYURETHANE MALE CONDOM
K050828 · Church & Dwight Co., Inc. · Feb 2006
EZ-ON CONDOM
K001974 · Mayer Laboratories · Oct 2001
LUBRICATED BAGGY TACTYLON CONDOM
K974121 · Sensicon Corp. · Jan 1998
SPERM PREPARATION MEDIA
K962816 · Intl., Inc. · Nov 1996
TROJAN POLYURETHANE CONDOM (MODIFICATION)
K955672 · Carter Products · Aug 1996
TROJAN POLYURETHANE CONDOM
K942697 · Carter Products · Jun 1995