Cleared Traditional

K955183 - SAFE KNIGHTS

K955183 is an FDA 510(k) clearance for SAFE KNIGHTS, manufactured by L & N Corp.. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Traditional 510(k) pathway after a 456-day FDA review.

K955183 · L & N Corp. · Obstetrics & Gynecology device
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Feb 1997
Decision
456d
Days
Class 2
Risk

K955183 is an FDA 510(k) clearance for the SAFE KNIGHTS. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by L & N Corp. (Brockton, US). The FDA issued a Cleared decision on February 11, 1997 after a review of 456 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Obstetrics & Gynecology submissions.

FDA 510(k) Submission Details - K955183

510(k) Number K955183 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1995
Decision Date February 11, 1997
Days to Decision 456 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
295d slower than avg
Panel avg: 161d · This submission: 456d
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 401
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K955183.
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
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
LOVING SMARTER - SAFER SEX
K963679 · Loving Smarter, Inc. · Dec 1996
K955183 · SAFE KNIGHTS
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