Cleared Traditional

K810049 - PEDICAT*

K810049 is the FDA 510(k) clearance for PEDICAT* by Pollak (Intl.), Ltd.. It is a Class 1 General Hospital device (product code KMJ) cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K810049 · Pollak (Intl.), Ltd. · General Hospital
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Apr 1981
Decision
98d
Days
Class 1
Risk

K810049 is an FDA 510(k) clearance for the PEDICAT*. Classified as Lubricant, Patient (product code KMJ), Class I - General Controls.

Submitted by Pollak (Intl.), Ltd. (Mchenry, US). The FDA issued a Cleared decision on April 21, 1981 after a review of 98 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Pollak (Intl.), Ltd. devices

Submission Details

510(k) Number K810049 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 1981
Decision Date April 21, 1981
Days to Decision 98 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
31d faster than avg
Panel avg: 129d · This submission: 98d
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

All 8
Devices cleared under the same product code (KMJ) and FDA review panel - the closest regulatory comparables to K810049.
STERILE SALINE SOLUTION
K854155 · I M, Inc. · Dec 1985
TOMAC LUBRICATING JELLY
K822143 · American Medical Systems, Inc. · Jul 1982
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