Cleared Traditional

K810049 - PEDICAT*

K810049 is an FDA 510(k) clearance for PEDICAT*, manufactured by Pollak (Intl.), Ltd.. The device is a Class 1 General Hospital device with 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

FDA 510(k) Submission Details - K810049

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.

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 K810049.
TOMAC LUBRICATING JELLY
K822143 · American Medical Systems, Inc. · Jul 1982
WET PACK LINE OF PRODUCTS
K820587 · Abco Dealers, Inc. · Mar 1982
A.D.T. PROCEDURES TRAY
K812297 · A.D.T. Lab Industries · Sep 1981
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