Cleared Traditional

K973557 - LUBRIGLIDE

K973557 is an FDA 510(k) clearance for LUBRIGLIDE, manufactured by Qualis, Inc.. The device is a Class 1 General Hospital device with product code KMJ cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K973557 · Qualis, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 1997
Decision
21d
Days
Class 1
Risk

K973557 is an FDA 510(k) clearance for the LUBRIGLIDE. Classified as Lubricant, Patient (product code KMJ), Class I - General Controls.

Submitted by Qualis, Inc. (Des Moines, US). The FDA issued a Cleared decision on October 10, 1997 after a review of 21 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6375 - the FDA general hospital 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.

FDA 510(k) Submission Details - K973557

510(k) Number K973557 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 1997
Decision Date October 10, 1997
Days to Decision 21 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
108d faster than avg
Panel avg: 129d · This submission: 21d
Pathway characteristics
Predicate-based equivalence.

KMJ Device Classification - Class 1, General Controls

Product Code KMJ Lubricant, Patient
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6375
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KMJ Lubricant, Patient

All 41
Devices cleared under the same product code (KMJ) and FDA review panel - the closest regulatory comparables to K973557.
E-Z LUBRICATING JELLY
K041060 · Chester Labs, Inc. · May 2004
GOOD LUBRICATIONS
K020586 · Biofilm, Inc. · Jan 2003
PDI STERILE LUBRICATING JELLY
K974768 · Nice-Pak Products, Inc. · Jan 1998
LUBRICATING JELLY, LOW VISCOSITY
K961502 · Span-America Medical Systems, Inc. · Jul 1996
EVRON GEL
K961222 · Pharmaceutical Innovations, Inc. · Jun 1996
AQUAGEL LUBRICATING JELLY
K951431 · Depuy Healthcare · Jul 1995
K973557 · LUBRIGLIDE
Download PDF FDA Summary Qualis, Inc.