Cleared Traditional

K932983 - COLORED CONDOMS (ESSENTIALS

K932983 is an FDA 510(k) clearance for COLORED CONDOMS (ESSENTIALS, manufactured by Sime Health, Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Traditional 510(k) pathway after a 384-day FDA review.

K932983 · Sime Health, Ltd. · Obstetrics & Gynecology device
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Jul 1994
Decision
384d
Days
Class 2
Risk

K932983 is an FDA 510(k) clearance for the COLORED CONDOMS (ESSENTIALS, MI VIDA, JIFFI). Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Sime Health, Ltd. (Seattle, US). The FDA issued a Cleared decision on July 7, 1994 after a review of 384 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 Sime Health, Ltd. devices

FDA 510(k) Submission Details - K932983

510(k) Number K932983 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 1993
Decision Date July 07, 1994
Days to Decision 384 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
224d slower than avg
Panel avg: 160d · This submission: 384d
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 60
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K932983.
SPERMICIDALLY LUBRICATED CONDOM
K940047 · Ansell, Inc. · Dec 1995
CONDOM
K940045 · Ansell, Inc. · Jan 1995
NON-LUBRICATED CONDOM
K940046 · Ansell, Inc. · Jan 1995
MCLAUGHLIN LAPAROSCOPIC GRASPER
K910578 · Marlo Surgical Technology · Apr 1991
TROJAN NATURALAMB NATURAL MEMBRANE CONDOM W/SPERM.
K902305 · Armkel, LLC · Mar 1991
TROJAN(R) EXTRA STR LATEX CONDOM W/SPERM SILI LUBR
K904000 · Armkel, LLC · Feb 1991