Cleared Traditional

K822143 - TOMAC LUBRICATING JELLY

K822143 is an FDA 510(k) clearance for TOMAC LUBRICATING JELLY, manufactured by American Medical Systems, Inc.. The device is a Class 1 General Hospital device with product code KMJ cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K822143 · American Medical Systems, Inc. · General Hospital
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Jul 1982
Decision
9d
Days
Class 1
Risk

K822143 is an FDA 510(k) clearance for the TOMAC LUBRICATING JELLY. Classified as Lubricant, Patient (product code KMJ), Class I - General Controls.

Submitted by American Medical Systems, Inc. (Walker, US). The FDA issued a Cleared decision on July 30, 1982 after a review of 9 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 American Medical Systems, Inc. devices

FDA 510(k) Submission Details - K822143

510(k) Number K822143 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 1982
Decision Date July 30, 1982
Days to Decision 9 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
120d faster than avg
Panel avg: 129d · This submission: 9d
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 26
Devices cleared under the same product code (KMJ) and FDA review panel - the closest regulatory comparables to K822143.
AMERICAN LUBRICATING JELLY STERILE 2.7G & 5G
K870742 · Span-America Medical Systems, Inc. · Jun 1987
AQUALUBE(TM)
K864556 · Parker Laboratories, Inc. · Dec 1986
STERILE SALINE SOLUTION
K854155 · I M, Inc. · Dec 1985
WET PACK LINE OF PRODUCTS
K820587 · Abco Dealers, Inc. · Mar 1982
A.D.T. PROCEDURES TRAY
K812297 · A.D.T. Lab Industries · Sep 1981
PEDICAT*
K810049 · Pollak (Intl.), Ltd. · Apr 1981