Cleared Traditional

K970633 - TUSTEX FLAVORED CONDOMS

K970633 is an FDA 510(k) clearance for TUSTEX FLAVORED CONDOMS, manufactured by Line One Laboratories. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K970633 · Line One Laboratories · Obstetrics & Gynecology device
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Mar 1997
Decision
29d
Days
Class 2
Risk

K970633 is an FDA 510(k) clearance for the TUSTEX FLAVORED CONDOMS. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Line One Laboratories (Los Angeles, US). The FDA issued a Cleared decision on March 21, 1997 after a review of 29 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 Line One Laboratories devices

FDA 510(k) Submission Details - K970633

510(k) Number K970633 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 1997
Decision Date March 21, 1997
Days to Decision 29 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
131d faster than avg
Panel avg: 160d · This submission: 29d
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 96
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K970633.
INNERWEAR, JIMMY-O RAINCOAT, RAINCOAT, JASMINE, DRINK
K972427 · Custom Services Intl., Inc. · Aug 1997
CONDOM (RUBBER), LUBRICATED, EXTRA STRENGTH
K970767 · Custom Services Intl., Inc. · Jun 1997
INNERWEAR/EXTRAWEAR/JIMMY-O RAINCOAT/ZEUS/GENTLEMEN'S CHOICE
K970792 · Titan Condoms · Jun 1997
TRUSTEX COLA FLAVORD CONDOM
K964598 · Line One Laboratories · Feb 1997
TRUSTEX CHOCOLATE FLAVORED CONDOM IN BLACK COLOR
K964599 · Line One Laboratories · Feb 1997
TRUSTEX GRAPE FLAVORED CONDOM IN PURPLE COLOR
K964591 · Line One Laboratories · Feb 1997