Cleared Traditional

K946374 - KIMONO MICROTHIN

K946374 is an FDA 510(k) clearance for KIMONO MICROTHIN, manufactured by Mayer Laboratories. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Traditional 510(k) pathway after a 329-day FDA review.

K946374 · Mayer Laboratories · Obstetrics & Gynecology device
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Nov 1995
Decision
329d
Days
Class 2
Risk

K946374 is an FDA 510(k) clearance for the KIMONO MICROTHIN. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Mayer Laboratories (Oakland, US). The FDA issued a Cleared decision on November 8, 1995 after a review of 329 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5300 - 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. Elevated predicate reliance profile. 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 Mayer Laboratories devices

FDA 510(k) Submission Details - K946374

510(k) Number K946374 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 1994
Decision Date November 08, 1995
Days to Decision 329 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
169d slower than avg
Panel avg: 160d · This submission: 329d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HIS Device Classification - Class 2, Special Controls

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.

Regulatory Peers - HIS Condom

All 82
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K946374.
ANSELL CONDOMS
K984392 · Ansell, Inc. · Jul 1999
LIFESTYLES XTRA PLEASURE
K983518 · Ansell, Inc. · Jul 1999
SPERMICIDALLY LUBRICATED CONDOM
K940047 · Ansell, Inc. · Dec 1995
KIMONO (CONDOMS)
K943064 · Mayer Laboratories · Sep 1995
MAXX
K946376 · Mayer Laboratories · Sep 1995
SAXON GOLD ULTRA SPERMICIDAL RAINBOW CONDOM
K943933 · Aladan Corp. · Jun 1995