Cleared Abbreviated

K022614 - INVIGRA

K022614 is an FDA 510(k) clearance for INVIGRA, manufactured by Indus Medicare , Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Abbreviated 510(k) pathway after a 245-day FDA review.

K022614 · Indus Medicare , Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2003
Decision
245d
Days
Class 2
Risk

K022614 is an FDA 510(k) clearance for the INVIGRA. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Indus Medicare , Ltd. (Hyderabad Andhra Pradesh, IN). The FDA issued a Cleared decision on April 8, 2003 after a review of 245 days - an extended review 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.

FDA 510(k) Submission Details - K022614

510(k) Number K022614 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2002
Decision Date April 08, 2003
Days to Decision 245 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
84d slower than avg
Panel avg: 161d · This submission: 245d
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 364
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K022614.
MERCATOR HEALTHCARE MALE LATEX CONDOM
K031369 · Mercator Healthcare , Ltd. · Oct 2003
MULTIPLE, MALE LATEX CONDOM [52MM OR 56MM NOMINAL WIDTH WITH SMOOTH OR DOTTED OR RIBBED OR 3 IN 1 (DOTTED/RIBBED/CONTOUR
K023333 · Pleasure Latex Products Sdn. Bhd. · Jun 2003
LIFESTYLES, CONTEMPO OR PRIVATE LABEL-MALE LATEX CONDOM WITH DESENSITIZING LUBRICANT
K030176 · Suretex, Ltd. · Apr 2003
LATEX CONDOM AND LATEX CONDOM LUBRICATED WITH NONOXYNOL-9
K024324 · Global Protection Corp. · Mar 2003
NON-SPERMICIDAL LUBRICATED MALE LATEX CONDOM
K023128 · Secure Scientific Sdn Bhd · Jan 2003
TROJAN MINT TINGLE BRAND LATEX CONDOMS
K023405 · Armkel, LLC · Dec 2002
K022614 · INVIGRA
Download PDF Indus Medicare , Ltd.