Cleared Traditional

K982924 - DUREX SENSIDOM LATEX CONDOM

K982924 is an FDA 510(k) clearance for DUREX SENSIDOM LATEX CONDOM, 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 88-day FDA review.

K982924 · London Intl., LLC · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1998
Decision
88d
Days
Class 2
Risk

K982924 is an FDA 510(k) clearance for the DUREX SENSIDOM LATEX CONDOM. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by London Intl., LLC (Dothan, US). The FDA issued a Cleared decision on November 16, 1998 after a review of 88 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all London Intl., LLC devices

FDA 510(k) Submission Details - K982924

510(k) Number K982924 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 1998
Decision Date November 16, 1998
Days to Decision 88 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 160d · This submission: 88d
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 K982924.
SHEER THIN
K984488 · Twe Companies, Inc. · Feb 1999
OASIS
K984218 · Glimex Corp. · Dec 1998
ROYALE BRAND LATEX CONDOMS SILICONE LUBRICANT COLORED-OR ASSORTED COLORS
K983320 · Suretex Prophylactics (India) , Ltd. · Dec 1998
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