Cleared Traditional

K122219 - THEYFIT MALE CONDOM

K122219 is an FDA 510(k) clearance for THEYFIT MALE CONDOM, manufactured by Theyfit. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Traditional 510(k) pathway after a 429-day FDA review.

K122219 · Theyfit · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2013
Decision
429d
Days
Class 2
Risk

K122219 is an FDA 510(k) clearance for the THEYFIT MALE CONDOM. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Theyfit (Swanee, US). The FDA issued a Cleared decision on September 27, 2013 after a review of 429 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 - K122219

510(k) Number K122219 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2012
Decision Date September 27, 2013
Days to Decision 429 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
268d slower than avg
Panel avg: 161d · This submission: 429d
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 357
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K122219.
MALE LATEX CONDOM
K132107 · Nulatex Sdn. Bhd. · Mar 2014
BLACK COLOURED CONDOM
K132597 · Karex Industries Sdn. Bhd. · Nov 2013
TROJAN JAGUAR MALE NATURAL RUBBER LATEX CONDOM WITH WARMING AND TINGLING LUBRICANT
K131887 · Church & Dwight Co., Inc. · Oct 2013
MALE LATEX CONDOM
K121241 · Nulatex Sdn. Bhd. · Feb 2013
LATEX MALE CONDOM (SMOOTH SURFACE) LATEX MALE CONDOM (TEXTURED SURFACE)
K120555 · Medical-Latex (Dua) Sdn. Bhd · Nov 2012
ORANGE COLORED CONDOMS ORANGE SCENT
K113056 · Karex Industries Sdn. Bhd. · Jul 2012
K122219 · THEYFIT MALE CONDOM
Download PDF FDA Summary Theyfit