Cleared Traditional

SHUR-LOCK ICE WRAP SYSTEM (K904819) - FDA 510(k) Clearance

Class I Physical Medicine device.

K904819 · Conco Medical Co. · Physical Medicine device
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Dec 1990
Decision
43d
Days
Class 1
Risk

K904819 is an FDA 510(k) clearance for the SHUR-LOCK ICE WRAP SYSTEM. Classified as Pack, Hot Or Cold, Disposable (product code IMD), Class I - General Controls.

Submitted by Conco Medical Co. (Bridgeport, US). The FDA issued a Cleared decision on December 6, 1990 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5710 - the FDA physical medicine 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 Conco Medical Co. devices

Submission Details

510(k) Number K904819 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 1990
Decision Date December 06, 1990
Days to Decision 43 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 115d · This submission: 43d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IMD Pack, Hot Or Cold, Disposable
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5710
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 - IMD Pack, Hot Or Cold, Disposable

All 81
Devices cleared under the same product code (IMD) and FDA review panel - the closest regulatory comparables to K904819.
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PERI-K PAD COLD PACK
K920760 · Baxter Healthcare Corp · Jul 1993
3M HEAT COMFORT PORTABLE SELF-HEATING PAD
K901778 · 3M Company · May 1990
EXOTHERMIC HEATING PAD
K850637 · Travenol Laboratories, S.A. · Apr 1985