Cleared Traditional

K974323 - LATEX CONDOMS NATURAL COLOUR WITH SILICONE OIL LUBRICANT

K974323 is an FDA 510(k) clearance for LATEX CONDOMS NATURAL COLOUR WITH SILIC..., manufactured by Reddy Medtech Health Products , Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K974323 · Reddy Medtech Health Products , Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1998
Decision
84d
Days
Class 2
Risk

K974323 is an FDA 510(k) clearance for the LATEX CONDOMS NATURAL COLOUR WITH SILICONE OIL LUBRICANT. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Reddy Medtech Health Products , Ltd. (Plainsboro, US). The FDA issued a Cleared decision on February 10, 1998 after a review of 84 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 Reddy Medtech Health Products , Ltd. devices

FDA 510(k) Submission Details - K974323

510(k) Number K974323 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 1997
Decision Date February 10, 1998
Days to Decision 84 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
77d faster than avg
Panel avg: 161d · This submission: 84d
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 257
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K974323.
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
PERSONAL LUBRICATING LIQUID
K973780 · Qualis, Inc. · Nov 1997
VERY PRIVATE INTIMATE MOISTURE
K971793 · Brandwynne Corp. · Nov 1997
KNIGHT LIGHT NONLUBRICATED CONDOM
K960552 · Global Protection Corp. · Nov 1997