Cleared Traditional

K931220 - SPERMICIDAL LUBRICATED CONDOM

K931220 is an FDA 510(k) clearance for SPERMICIDAL LUBRICATED CONDOM, manufactured by Monsys USA, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code LTZ cleared through the Traditional 510(k) pathway after a 1169-day FDA review.

K931220 · Monsys USA, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1996
Decision
1169d
Days
Class 2
Risk

K931220 is an FDA 510(k) clearance for the SPERMICIDAL LUBRICATED CONDOM. Classified as Condom With Nonoxynol-9 (product code LTZ), Class II - Special Controls.

Submitted by Monsys USA, Inc. (Philippi, US). The FDA issued a Cleared decision on May 22, 1996 after a review of 1169 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5310 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Obstetrics & Gynecology submissions.

View all Monsys USA, Inc. devices

FDA 510(k) Submission Details - K931220

510(k) Number K931220 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1993
Decision Date May 22, 1996
Days to Decision 1169 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
1009d slower than avg
Panel avg: 160d · This submission: 1169d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LTZ Device Classification - Class 2, Special Controls

Product Code LTZ Condom With Nonoxynol-9
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.5310
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 - LTZ Condom With Nonoxynol-9

All 15
Devices cleared under the same product code (LTZ) and FDA review panel - the closest regulatory comparables to K931220.
OLYMPUS,JASMINE,JIMMY-O RAINCOAT,DRINK,ARES,APHRODITE,ZEUS,APOLLO,SELFCARE,CAREPLUS,TITAN
K963322 · Custom Services Intl., Inc. · Jan 1997
LONDON ROYAL CONSUMER PRODUCTS LATEX CONDOMS
K953813 · London International U.S. Holdings, Inc. · Jul 1996
DUREX, RAMSES, SHEIK
K952415 · London International U.S. Holdings, Inc. · Jul 1996
MAGNUM PLUS LATEX CONDOMS WITH SPERMICIDAL LUB.
K904273 · Carter Products · Oct 1990