Cleared Traditional

K910788 - CMI TENDER TOUCH VE #303TT AND 404TT

K910788 is an FDA 510(k) clearance for CMI TENDER TOUCH VE #303TT AND 404TT, manufactured by Challenge Mfg., Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K910788 · Challenge Mfg., Inc. · Obstetrics & Gynecology device
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May 1991
Decision
73d
Days
Class 2
Risk

K910788 is an FDA 510(k) clearance for the CMI TENDER TOUCH VE #303TT AND 404TT. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Challenge Mfg., Inc. (Bend, US). The FDA issued a Cleared decision on May 9, 1991 after a review of 73 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 Challenge Mfg., Inc. devices

FDA 510(k) Submission Details - K910788

510(k) Number K910788 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 1991
Decision Date May 09, 1991
Days to Decision 73 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 160d · This submission: 73d
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 202
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K910788.
CONDOM
K940045 · Ansell, Inc. · Jan 1995
NON-LUBRICATED CONDOM
K940046 · Ansell, Inc. · Jan 1995
TROJAN (TM-TBD) CONDOM
K912901 · Carter Products · Feb 1992
MCLAUGHLIN LAPAROSCOPIC GRASPER
K910578 · Marlo Surgical Technology · Apr 1991
TROJAN NATURALAMB NATURAL MEMBRANE CONDOM W/SPERM.
K902305 · Armkel, LLC · Mar 1991
TROJAN(R) EXTRA STR LATEX CONDOM W/SPERM SILI LUBR
K904000 · Armkel, LLC · Feb 1991