Cleared Abbreviated

K993405 - REMED MALE DOTTED CONDOM PREVENTOR, LUCKY BOY, SUMMIT

K993405 is an FDA 510(k) clearance for REMED MALE DOTTED CONDOM PREVENTOR, 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.

K993405 · Remed Pharma · Obstetrics & Gynecology device
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Feb 2000
Decision
130d
Days
Class 2
Risk

K993405 is an FDA 510(k) clearance for the REMED MALE DOTTED CONDOM PREVENTOR, LUCKY BOY, 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 - K993405

510(k) Number K993405 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 131
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K993405.
REMED MALE LATEX CONDOM (DOUBLE WHOOPER) PREVENTOR, LUCKY BOY AND SUMMIT
K993395 · Remed Pharma · Feb 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 RIBBED CONDOM PREVENTOR, LUCKY BOY SUMMIT
K993408 · Remed Pharma · Feb 2000
REMED MALE LATEX CONDOM (SUPER DUPER) PREVENTOR, LUCKY BOY, AND SUMMIT
K993390 · Remed Pharma · Feb 2000
SIMPLEX CONDOMS, LATEX CONDOMS-FLAVORED AND LUBRICATED
K993779 · P.T. Vonix Latexindo Condom (Rubber) Mfg. · Feb 2000