Cleared Traditional

K963679 - LOVING SMARTER - SAFER SEX

K963679 is an FDA 510(k) clearance for LOVING SMARTER - SAFER SEX, manufactured by Loving Smarter, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K963679 · Loving Smarter, Inc. · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
Dec 1996
Decision
90d
Days
Class 2
Risk

K963679 is an FDA 510(k) clearance for the LOVING SMARTER - SAFER SEX. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Loving Smarter, Inc. (Winton, US). The FDA issued a Cleared decision on December 12, 1996 after a review of 90 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Loving Smarter, Inc. devices

FDA 510(k) Submission Details - K963679

510(k) Number K963679 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 1996
Decision Date December 12, 1996
Days to Decision 90 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 160d · This submission: 90d
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 186
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K963679.
SAFE KNIGHTS
K955183 · L & N Corp. · Feb 1997
OLYMPUS,JASMINE,JIMMY-O RAINCOAT,DRINK,ARES,APHRODIT,ZEUS,APOLLO,SELFCARE,CAREPLUS,TITAN
K963319 · Custom Services Intl., Inc. · Jan 1997
OLYMPUS,JASMINE,JIMMY-O RAINCOAT,DRINK,ARES,APHRODITE,ZEUS,APOLLO,SELFCARE,CAREPLUS,TITAN
K963321 · Custom Services Intl., Inc. · Jan 1997
CONDOM
K960710 · Polar Latex , Ltd. · Oct 1996
TRUSTEX FLAVOR CONDON IN COLORS
K946103 · Line One Laboratories & Trading Co. · Jul 1996
K-Y PERSONAL LUBRICANT
K955648 · Ortho Pharmaceutical Corp. · Jun 1996