Cleared Traditional

K980319 - DUREX ULTRA COMFORT

K980319 is an FDA 510(k) clearance for DUREX ULTRA COMFORT, manufactured by London Intl., LLC. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K980319 · London Intl., LLC · Obstetrics & Gynecology device
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May 1998
Decision
113d
Days
Class 2
Risk

K980319 is an FDA 510(k) clearance for the DUREX ULTRA COMFORT. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by London Intl., LLC (Dothan, US). The FDA issued a Cleared decision on May 20, 1998 after a review of 113 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 London Intl., LLC devices

FDA 510(k) Submission Details - K980319

510(k) Number K980319 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 1998
Decision Date May 20, 1998
Days to Decision 113 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
47d faster than avg
Panel avg: 160d · This submission: 113d
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 109
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K980319.
DUREX LUBRAGEL LATEX CONDOM
K983380 · London Intl., LLC · Nov 1998
JUST BETWEEN US, PERSONAL LUBRICANT & CONDOM
K982673 · Key West Fragrance & Cosmetic · Oct 1998
DUREX COLORS AND SCENTS
K980174 · London Intl., LLC · Aug 1998
DUREX LATEX CONDOMS
K980204 · London Intl., LLC · Apr 1998
HTL MALE CONDOM
K980019 · Reddy Medtech Health Products , Ltd. · Apr 1998
WORLDS BEST BRAND NON-LUBRICATED, WORLDS BEST BRAND LUBRICATED
K971028 · Worlds-Best Gummivarefabrik A/S · Mar 1998