Cleared Traditional

K974121 - LUBRICATED BAGGY TACTYLON CONDOM

K974121 is an FDA 510(k) clearance for LUBRICATED BAGGY 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 90-day FDA review.

K974121 · Sensicon Corp. · Obstetrics & Gynecology device
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Jan 1998
Decision
90d
Days
Class 2
Risk

K974121 is an FDA 510(k) clearance for the LUBRICATED BAGGY 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 January 29, 1998 after a review of 90 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.

View all Sensicon Corp. devices

FDA 510(k) Submission Details - K974121

510(k) Number K974121 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 1997
Decision Date January 29, 1998
Days to Decision 90 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
70d faster than avg
Panel avg: 160d · This submission: 90d
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 K974121.
LIFESTYLES LUBRICATED POLYISOPRENE LATEX MALE CONDOM
K070800 · Ansell Healthcare Products, LLC · Mar 2008
TROJAN SUPRA LUBRICATED POLYURETHANE MALE CONDOM
K050828 · Church & Dwight Co., Inc. · Feb 2006
EZ-ON CONDOM
K001974 · Mayer Laboratories · Oct 2001
TACTYLON CONDOM
K971590 · Sensicon Corp. · Oct 1997
SPERM PREPARATION MEDIA
K962816 · Intl., Inc. · Nov 1996
TROJAN POLYURETHANE CONDOM (MODIFICATION)
K955672 · Carter Products · Aug 1996