Cleared Abbreviated

K131866 - SUSTAIN

K131866 is an FDA 510(k) clearance for SUSTAIN, manufactured by Hollender Sustainable Brands, LLC. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Abbreviated 510(k) pathway after a 311-day FDA review.

K131866 · Hollender Sustainable Brands, LLC · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2014
Decision
311d
Days
Class 2
Risk

K131866 is an FDA 510(k) clearance for the SUSTAIN. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Hollender Sustainable Brands, LLC (Crofton, US). The FDA issued a Cleared decision on May 1, 2014 after a review of 311 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K131866

510(k) Number K131866 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 2013
Decision Date May 01, 2014
Days to Decision 311 days
Submission Type Abbreviated
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
150d slower than avg
Panel avg: 161d · This submission: 311d
Pathway characteristics
Standards-based clearance path.

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 360
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K131866.
NATURAL RUBBER LATEX MALE CONDOMS
K141059 · Karex Industries Sdn. Bhd. · Aug 2014
OKAMOTO STUDDED CONDOM
K141256 · Okamoto USA, Inc. · Jul 2014
MEGA BIG BOY CONDOM
K140379 · Okamoto USA, Inc. · Jul 2014
INSTINCT
K132390 · Profilatex, S.A. DE C.V. · Apr 2014
MALE LATEX CONDOM
K132107 · Nulatex Sdn. Bhd. · Mar 2014
BLACK COLOURED CONDOM
K132597 · Karex Industries Sdn. Bhd. · Nov 2013
K131866 · SUSTAIN
Download PDF FDA Summary Hollender Sustainable…