Cleared Abbreviated

K993409 - REMED MALE TUTTI FRUTTI CONDOM (COCONUT) PREVENTOR, LUCKY BOY, SUMMIT

K993409 is an FDA 510(k) clearance for REMED MALE TUTTI FRUTTI CONDOM (COCONUT..., 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 315-day FDA review.

K993409 · Remed Pharma · Obstetrics & Gynecology device
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Aug 2000
Decision
315d
Days
Class 2
Risk

K993409 is an FDA 510(k) clearance for the REMED MALE TUTTI FRUTTI CONDOM (COCONUT) 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 August 18, 2000 after a review of 315 days - an unusually long review period, suggesting complex equivalence evaluation.

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.

FDA 510(k) Submission Details - K993409

510(k) Number K993409 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 1999
Decision Date August 18, 2000
Days to Decision 315 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
154d slower than avg
Panel avg: 161d · This submission: 315d
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 361
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K993409.
NATURAL ORDINARY RIBBED,DOTTED,AND CONTOURED (MALE RUBBER LATEX CONDOM, LUBRICATED W/SILICONE OIL
K002060 · Dongkuk Techco Rubber Industries · Sep 2000
REMED MALE TUTTI FRUTTI CONDOM (BANANA), PREVENTOR, LUCKY BOY, SUMMIT
K993389 · Remed Pharma · Aug 2000
REMED MALE TUTTI FRUTTI CONDOM (STRAWBERRY) PREVENTOR, LUCKY BOY, SUMMIT
K993403 · Remed Pharma · Aug 2000
OSMANTHUS, KONGFU, AND GOBON, NATURAL RUBBER LATEX CONDOMS
K994118 · Guilin Latex Factory · Aug 2000
LIFESTYLES, CONTEMPO OR PRIVATE LABEL LARGE CONDOM
K001883 · Ansell Healthcare, Inc. · Jul 2000
MALE LATEX COMDOM WITH DOTTED SURFACE
K001221 · Pleasure Latex Products Sdn. Bhd. · May 2000
K993409 · REMED MALE TUTTI FRUTTI CONDOM (COCONUT) PREVENTOR, LUCKY BOY, SUMMIT
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