Cleared Traditional

K122219 - THEYFIT MALE CONDOM (FDA 510(k) Clearance)

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K122219 · Theyfit · Obstetrics & Gynecology device
Download Printable Device Report (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.

View all Theyfit devices

Submission Details

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
Regulatory Context
Review time vs. panel average
269d slower than avg
Panel avg: 160d · This submission: 429d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 399
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K122219.
LifeStyles® HydraFeel Natural Rubber Latex Condom
K252521 · Suretex Limited · Nov 2025
Natural rubber latex male condom
K250034 · Shaoguan Regenex Pharmaceuticals Co., Ltd. · Jul 2025
Lelo Hex Lubricated Natural Rubber Latex Condom
K243421 · Lelo, Inc. · Mar 2025
Trojan™ Ultra Ribbed Ecstasy latex condom with lubricant (Trojan™ Ultra Ribbed Ecstasy)
K243640 · Church & Dwight Co., Inc. · Feb 2025
0.04 ZERO ZERO FOUR Male Latex Condom
K243584 · Okamoto USA, Inc. · Feb 2025
LifeStyles NRL Textured Condom
K232279 · Suretex Limited · Oct 2023