Cleared Abbreviated

K993733 - LOVE LOCKERS

K993733 is an FDA 510(k) clearance for LOVE LOCKERS, manufactured by Medtech Products , Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Abbreviated 510(k) pathway after a 137-day FDA review.

K993733 · Medtech Products , Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2000
Decision
137d
Days
Class 2
Risk

K993733 is an FDA 510(k) clearance for the LOVE LOCKERS. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Medtech Products , Ltd. (Chennai, IN). The FDA issued a Cleared decision on March 20, 2000 after a review of 137 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Medtech Products , Ltd. devices

FDA 510(k) Submission Details - K993733

510(k) Number K993733 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 1999
Decision Date March 20, 2000
Days to Decision 137 days
Submission Type Abbreviated
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
23d faster than avg
Panel avg: 160d · This submission: 137d
Pathway characteristics
Standards-based clearance path.

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 131
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K993733.
REMED MALE TUTTI FRUTTI CONDOM (COCONUT) PREVENTOR, LUCKY BOY, SUMMIT
K993409 · Remed Pharma · Aug 2000
TROJAN EXTRA LARGE LATEX CONDOM
K001212 · Armkel, LLC · May 2000
TROJAN LATEX CONDOM WITH MALE GENITAL DESENSITIZER LUBRICANT
K000748 · Armkel, LLC · Apr 2000
DOUBLE SPRINGERS
K993735 · Medtech Products , Ltd. · Mar 2000
MIGHTY MAN (DYNAMIC LINKERS)
K993737 · Medtech Products , Ltd. · Mar 2000
REMED MALE LATEX CONDOM (DOUBLE WHOOPER) PREVENTOR, LUCKY BOY AND SUMMIT
K993395 · Remed Pharma · Feb 2000