Cleared Traditional

COOL-ZONE (K963809) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K963809 · Kappler USA · General Hospital
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Optimized for regulatory review, auditing and printing
Nov 1996
Decision
58d
Days
Class 2
Risk

K963809 is an FDA 510(k) clearance for the COOL-ZONE. Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Kappler USA (Guntersville, US). The FDA issued a Cleared decision on November 20, 1996 after a review of 58 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4040 - 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 Kappler USA devices

Submission Details

510(k) Number K963809 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 1996
Decision Date November 20, 1996
Days to Decision 58 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 129d · This submission: 58d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FYA Gown, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4040
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FYA Gown, Surgical

All 104
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K963809.
MEDLINE MEDCREST SURGICAL GOWNS AND SURGICAL DRAPES
K982694 · Medline Industries, Inc. · Dec 1998
MEDINE DISPOSABLE STERILE ZONED IMPERVIOUS SURGICAL GOWNS
K982693 · Medline Industries, Inc. · Oct 1998
PROVISION SURGICAL HELMET SYSTEM
K972832 · Depuy, Inc. · Oct 1997
CONVERTORS POLYOLEFIN FABRIC GOWNS
K961341 · Baxter Healthcare Corp · Oct 1996
DEPUY STERILE VIEW BARRIER HOOD/GOWN WITH HYTREL
K961239 · Depuy, Inc. · Sep 1996
INTERWOVEN(TM) REUSABLE SURGICAL GOWN
K945658 · Baxter Healthcare Corp · Mar 1995