Cleared Traditional

K991049 - CLIMAX

K991049 is an FDA 510(k) clearance for CLIMAX, manufactured by Medilatex Sdn. Bhd.. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K991049 · Medilatex Sdn. Bhd. · Obstetrics & Gynecology device
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Jun 1999
Decision
77d
Days
Class 2
Risk

K991049 is an FDA 510(k) clearance for the CLIMAX. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Medilatex Sdn. Bhd. (Kulai, Johor, MY). The FDA issued a Cleared decision on June 15, 1999 after a review of 77 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 Medilatex Sdn. Bhd. devices

FDA 510(k) Submission Details - K991049

510(k) Number K991049 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 1999
Decision Date June 15, 1999
Days to Decision 77 days
Submission Type Traditional
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
83d faster than avg
Panel avg: 160d · This submission: 77d
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 134
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K991049.
SUMMER'S EVE LUBRICATING JELLY
K990597 · C.B. Fleet Co., Inc. · Jul 1999
LIFESTYLES XTRA PLEASURE
K983518 · Ansell, Inc. · Jul 1999
MALE NATURAL RUBBER LATEX CONDOM (WITH LUBRICATION)
K990925 · Hardcover Products, Inc. · Jun 1999
INVIGRA
K991374 · Indus Medicare , Ltd. · Jun 1999
CVS PERSONAL LUBRICANT
K983216 · San-Mar Laboratories, Inc. · May 1999
MAXIMA, TRUSTEX, RIA AND PREMIUM CONDOMS
K980964 · Ls Rubber Sdn Bhd · Mar 1999