Cleared Traditional

SPERMICIDAL LUBRICATED CONDOM (K931220) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K931220 · Monsys USA, Inc. · Obstetrics & Gynecology device
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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

Submission Details

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
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.

Device Classification

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.