Cleared Abbreviated

K984218 - OASIS

K984218 is an FDA 510(k) clearance for OASIS, manufactured by Glimex Corp.. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Abbreviated 510(k) pathway after a 23-day FDA review.

K984218 · Glimex Corp. · Obstetrics & Gynecology device
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Dec 1998
Decision
23d
Days
Class 2
Risk

K984218 is an FDA 510(k) clearance for the OASIS. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Glimex Corp. (Folsom, US). The FDA issued a Cleared decision on December 17, 1998 after a review of 23 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 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 Glimex Corp. devices

FDA 510(k) Submission Details - K984218

510(k) Number K984218 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 1998
Decision Date December 17, 1998
Days to Decision 23 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
137d faster than avg
Panel avg: 160d · This submission: 23d
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 109
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K984218.
MAXIMA, TRUSTEX, RIA AND PREMIUM CONDOMS
K980964 · Ls Rubber Sdn Bhd · Mar 1999
SURE
K982380 · Pleasure Latex Products Sdn. Bhd. · Feb 1999
SHEER THIN
K984488 · Twe Companies, Inc. · Feb 1999
ROYALE BRAND LATEX CONDOMS SILICONE LUBRICANT COLORED-OR ASSORTED COLORS
K983320 · Suretex Prophylactics (India) , Ltd. · Dec 1998
DUREX SENSIDOM LATEX CONDOM
K982924 · London Intl., LLC · Nov 1998
DUREX LUBRAGEL LATEX CONDOM
K983380 · London Intl., LLC · Nov 1998