Cleared Traditional

K952415 - DUREX, RAMSES, SHEIK

K952415 is an FDA 510(k) clearance for DUREX, manufactured by London International U.S. Holdings, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code LTZ cleared through the Traditional 510(k) pathway after a 419-day FDA review.

K952415 · London International U.S. Holdings, Inc. · Obstetrics & Gynecology device
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Jul 1996
Decision
419d
Days
Class 2
Risk

K952415 is an FDA 510(k) clearance for the DUREX, RAMSES, SHEIK. Classified as Condom With Nonoxynol-9 (product code LTZ), Class II - Special Controls.

Submitted by London International U.S. Holdings, Inc. (Sarasota, US). The FDA issued a Cleared decision on July 15, 1996 after a review of 419 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 London International U.S. Holdings, Inc. devices

FDA 510(k) Submission Details - K952415

510(k) Number K952415 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 1995
Decision Date July 15, 1996
Days to Decision 419 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
259d slower than avg
Panel avg: 160d · This submission: 419d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LTZ Device Classification - Class 2, Special Controls

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.

Regulatory Peers - LTZ Condom With Nonoxynol-9

All 15
Devices cleared under the same product code (LTZ) and FDA review panel - the closest regulatory comparables to K952415.
INNERWEAR/EXTRAWEAR/JIMMY-O RAINCOAT/ZEUS/GENTLEMEN'S CHOICE/JASMINE/DRINK/NAUGHTY
K970791 · Custom Services Intl., Inc. · Jun 1997
OLYMPUS,JASMINE,JIMMY-O RAINCOAT,DRINK,ARES,APHRODITE,ZEUS,APOLLO,SELFCARE,CAREPLUS,TITAN
K963322 · Custom Services Intl., Inc. · Jan 1997
LONDON ROYAL CONSUMER PRODUCTS LATEX CONDOMS
K953813 · London International U.S. Holdings, Inc. · Jul 1996
SPERMICIDAL LUBRICATED CONDOM
K931220 · Monsys USA, Inc. · May 1996
MAGNUM PLUS LATEX CONDOMS WITH SPERMICIDAL LUB.
K904273 · Carter Products · Oct 1990