Cleared Traditional

K980019 - HTL MALE CONDOM

K980019 is an FDA 510(k) clearance for HTL MALE CONDOM, 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 89-day FDA review.

K980019 · Reddy Medtech Health Products , Ltd. · Obstetrics & Gynecology device
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Apr 1998
Decision
89d
Days
Class 2
Risk

K980019 is an FDA 510(k) clearance for the HTL MALE CONDOM. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Reddy Medtech Health Products , Ltd. (Chennai, IN). The FDA issued a Cleared decision on April 1, 1998 after a review of 89 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 - K980019

510(k) Number K980019 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 1998
Decision Date April 01, 1998
Days to Decision 89 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 160d · This submission: 89d
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 60
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K980019.
TROJAN LATEX CONDOM WITH MALE GENITAL DESENSITIZER LUBRICANT
K000748 · Armkel, LLC · Apr 2000
ANSELL CONDOMS
K984392 · Ansell, Inc. · Jul 1999
LIFESTYLES XTRA PLEASURE
K983518 · Ansell, Inc. · Jul 1999
SPERMICIDALLY LUBRICATED CONDOM
K940047 · Ansell, Inc. · Dec 1995
CONDOM
K940045 · Ansell, Inc. · Jan 1995
NON-LUBRICATED CONDOM
K940046 · Ansell, Inc. · Jan 1995