Cleared Abbreviated

K993395 - REMED MALE LATEX CONDOM (DOUBLE WHOOPER) PREVENTOR, LUCKY BOY AND SUMMIT

K993395 is an FDA 510(k) clearance for REMED MALE LATEX CONDOM (DOUBLE WHOOPER..., manufactured by Remed Pharma. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Abbreviated 510(k) pathway after a 130-day FDA review.

K993395 · Remed Pharma · Obstetrics & Gynecology device
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Feb 2000
Decision
130d
Days
Class 2
Risk

K993395 is an FDA 510(k) clearance for the REMED MALE LATEX CONDOM (DOUBLE WHOOPER) PREVENTOR, LUCKY BOY AND SUMMIT. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Remed Pharma (Crofton, US). The FDA issued a Cleared decision on February 15, 2000 after a review of 130 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 Remed Pharma devices

FDA 510(k) Submission Details - K993395

510(k) Number K993395 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 1999
Decision Date February 15, 2000
Days to Decision 130 days
Submission Type Abbreviated
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
30d faster than avg
Panel avg: 160d · This submission: 130d
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 128
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K993395.
LOVE LOCKERS
K993733 · Medtech Products , Ltd. · Mar 2000
DOUBLE SPRINGERS
K993735 · Medtech Products , Ltd. · Mar 2000
MIGHTY MAN (DYNAMIC LINKERS)
K993737 · Medtech Products , Ltd. · Mar 2000
REMED MALE EXTRA STRENGTH CONDOM PREVENTOR, LUCKY BOY, SUMMIT
K993396 · Remed Pharma · Feb 2000
REMED MALE LATEX CONDOM (CLASSIC) PREVENTOR, LUCKY BOY, AND SUMMIT
K993404 · Remed Pharma · Feb 2000
REMED MALE DOTTED CONDOM PREVENTOR, LUCKY BOY, SUMMIT
K993405 · Remed Pharma · Feb 2000