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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 161d · 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 315
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K040085.
ASTROGLIDE BRAND WARMING LIQUID PERSONAL LUBRICANT
K041432 · Biofilm, Inc. · Nov 2004
INNOLATEX MALE LATEX CONDOMS COLORED AND SCENTED
K041837 · Innolatex Sdn. Bhd · Sep 2004
DUREX STUDDED/RIBBED LUBRICATED LATEX CONDOM
K040185 · Ssl Americas · Apr 2004
DUREX FLAVORED LATEX CONDOM
K032227 · Ssl Americas, Inc. · Mar 2004
DUREX PLAY LUBRICANT
K032124 · Ssl Americas, Inc. · Jan 2004
LONG LOVE CONDOM
K033541 · Unidus Corp. · Dec 2003
K040085 · PERSONAL WARMING LUBRICANT
Download PDF FDA Summary Qualis, Inc.