Cleared Traditional

K973780 - PERSONAL LUBRICATING LIQUID

K973780 is an FDA 510(k) clearance for PERSONAL LUBRICATING LIQUID, 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 54-day FDA review.

K973780 · Qualis, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1997
Decision
54d
Days
Class 2
Risk

K973780 is an FDA 510(k) clearance for the PERSONAL LUBRICATING LIQUID. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Qualis, Inc. (Des Moines, US). The FDA issued a Cleared decision on November 26, 1997 after a review of 54 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Qualis, Inc. devices

FDA 510(k) Submission Details - K973780

510(k) Number K973780 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 1997
Decision Date November 26, 1997
Days to Decision 54 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
106d faster than avg
Panel avg: 160d · This submission: 54d
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 96
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K973780.
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CLINIJEL
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ROYALE BRAND LATEX CONDOMS (SILICONE)-COLORED/ASSORTED COLORS
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