Cleared Traditional

K-GEL (K872128) - FDA 510(k) Clearance

Class I General Hospital device.

K872128 · Taro Pharmaceuticals, Inc. · General Hospital
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Jun 1987
Decision
10d
Days
Class 1
Risk

K872128 is an FDA 510(k) clearance for the K-GEL. Classified as Lubricant, Patient (product code KMJ), Class I - General Controls.

Submitted by Taro Pharmaceuticals, Inc. (Downsview, Ont., CA). The FDA issued a Cleared decision on June 12, 1987 after a review of 10 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.

View all Taro Pharmaceuticals, Inc. devices

Submission Details

510(k) Number K872128 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 1987
Decision Date June 12, 1987
Days to Decision 10 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
119d faster than avg
Panel avg: 129d · This submission: 10d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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

Devices cleared under the same product code (KMJ) and FDA review panel - the closest regulatory comparables to K872128.
DYNACOR LUBRICATION GEL
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WET PACK LINE OF PRODUCTS
K820587 · Abco Dealers, Inc. · Mar 1982
K-Y LUBRICATING JELLY
K810310 · Johnson & Johnson Professionals, Inc. · Apr 1981
LUBRICATING JELLY
K791243 · Abco Dealers, Inc. · Aug 1979
PRESERVE LUBRICANT CODE NO. 43=4035
K770498 · Codman & Shurtleff, Inc. · Jun 1977