Cleared Traditional

K901202 - TROJAN NATURALAMB LUBRICATED NATURAL MO...

K901202 is an FDA 510(k) clearance for TROJAN NATURALAMB LUBRICATED NATURAL MO..., manufactured by Carter Products. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K901202 · Carter Products · Obstetrics & Gynecology device
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Jun 1990
Decision
99d
Days
Class 2
Risk

K901202 is an FDA 510(k) clearance for the TROJAN NATURALAMB LUBRICATED NATURAL MODIFIED. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Carter Products (Cranbury, US). The FDA issued a Cleared decision on June 19, 1990 after a review of 99 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 Carter Products devices

FDA 510(k) Submission Details - K901202

510(k) Number K901202 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 1990
Decision Date June 19, 1990
Days to Decision 99 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 160d · This submission: 99d
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 74
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K901202.
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
TROJANS LATEX CONDOMS (MODIFIED LABELING)
K901190 · Carter Products · Apr 1990
TROJAN-ENZ LATEX CONDOMS (MODIFIED LABELING)
K901191 · Carter Products · Apr 1990
TROJAN-ENZ LUBRI. CONDOMS (MODIFIED LABELING)
K901192 · Carter Products · Apr 1990