Cleared Traditional

K880820 - OKAMOTO CONDOMS SPERMICIDALLY LUBRICATED

K880820 is the FDA 510(k) clearance for OKAMOTO CONDOMS SPERMICIDALLY LUBRICATED by Schmid Laboratories, Inc.. It is a Class 2 Obstetrics & Gynecology device (product code HIS) cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K880820 · Schmid Laboratories, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1988
Decision
112d
Days
Class 2
Risk

K880820 is an FDA 510(k) clearance for the OKAMOTO CONDOMS SPERMICIDALLY LUBRICATED. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Schmid Laboratories, Inc. (Little Falls, US). The FDA issued a Cleared decision on June 21, 1988 after a review of 112 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 Schmid Laboratories, Inc. devices

Submission Details

510(k) Number K880820 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 1988
Decision Date June 21, 1988
Days to Decision 112 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 160d · This submission: 112d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.