Cleared Traditional

K760951 - DEVON COOL FACE (FDA 510(k) Clearance)

Class I General Hospital device.

K760951 · Devon Industries, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1976
Decision
59d
Days
Class 1
Risk

K760951 is an FDA 510(k) clearance for the DEVON COOL FACE. Classified as Bag, Ice (product code KYR), Class I - General Controls.

Submitted by Devon Industries, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 30, 1976 after a review of 59 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6050 - 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 Devon Industries, Inc. devices

Submission Details

510(k) Number K760951 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 1976
Decision Date December 30, 1976
Days to Decision 59 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
69d faster than avg
Panel avg: 128d · This submission: 59d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KYR Bag, Ice
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6050
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.