Cleared Traditional

K103119 - BILLY BOY MALE LATEX CONDOM

K103119 is an FDA 510(k) clearance for BILLY BOY MALE LATEX CONDOM, manufactured by Sheila Pickering PHD. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K103119 · Sheila Pickering PHD · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2011
Decision
125d
Days
Class 2
Risk

K103119 is an FDA 510(k) clearance for the BILLY BOY MALE LATEX CONDOM. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Sheila Pickering PHD (Los Altos, US). The FDA issued a Cleared decision on February 24, 2011 after a review of 125 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.

FDA 510(k) Submission Details - K103119

510(k) Number K103119 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 2010
Decision Date February 24, 2011
Days to Decision 125 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 161d · This submission: 125d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Regulatory Technology Services, LLC
MARK JOB

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HIS Condom

All 390
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K103119.
KIMONO MICROTHIN WITH AQUA LUBE, REALITY ULTRA LUBRICATED
K113686 · Mayer Laboratories, Inc. · Mar 2012
LARGE/EXTRA LAGRE CONDOM
K113061 · Karex Industries Sdn. Bhd. · Dec 2011
BILLY BOY MALE LATEX CONDOM
K111093 · Mapa GmbH · Jun 2011
MALE LATEX CONDOM (STRAIGHT SIDE OR CONTOURED OR FLARED IN SHAPE, EITHER TEXTURED OR NON-TEXTURED , LUBRICATED OR NON-LU
K092586 · Innolatex (Thailand) Limited · May 2010
THAI NIPPON MALE LATEX CONDOM
K081265 · Thai Nippon Rubber Industry Co., Ltd. · Oct 2009
M. DIOR BRAND
K083817 · Suzhou Colour-Way Enterprise Development Co., Ltd. · Sep 2009

FDA 510(k) Resources - Obstetrics & Gynecology

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

K103119 · BILLY BOY MALE LATEX CONDOM
Download PDF FDA Summary Sheila Pickering PHD