Cleared Traditional

K040085 - PERSONAL WARMING LUBRICANT

K040085 is an FDA 510(k) clearance for PERSONAL WARMING LUBRICANT, manufactured by Qualis, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K040085 · Qualis, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2004
Decision
95d
Days
Class 2
Risk

K040085 is an FDA 510(k) clearance for the PERSONAL WARMING LUBRICANT. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Qualis, Inc. (Des Moines, US). The FDA issued a Cleared decision on April 20, 2004 after a review of 95 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.

View all Qualis, Inc. devices

FDA 510(k) Submission Details - K040085

510(k) Number K040085 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 2004
Decision Date April 20, 2004
Days to Decision 95 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
65d faster than avg
Panel avg: 160d · This submission: 95d
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 97
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K040085.
TROJAN-ENZ BRAND
K071313 · Church & Dwight Co., Inc. · Oct 2007
TROJAN THINTENSITY BRAND MALE LATEX CONDOM
K071272 · Church & Dwight Co., Inc. · Sep 2007
ASTROGLIDE BRAND WARMING LIQUID PERSONAL LUBRICANT
K041432 · Biofilm, Inc. · Nov 2004
TROJAN MINT TINGLE BRAND LATEX CONDOMS
K023405 · Armkel, LLC · Dec 2002
TROJAN EXTRA LARGE LATEX CONDOM
K001212 · Armkel, LLC · May 2000
TROJAN LATEX CONDOM WITH MALE GENITAL DESENSITIZER LUBRICANT
K000748 · Armkel, LLC · Apr 2000