Cleared Traditional

K963809 - COOL-ZONE

K963809 is an FDA 510(k) clearance for COOL-ZONE, manufactured by Kappler USA. The device is a Class 2 General Hospital device with product code FYA cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K963809 · Kappler USA · General Hospital
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K963809

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
Combination Product No
PCCP Authorized No
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.

FYA Device Classification - Class 2, Special Controls

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 211
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K963809.
ULTRASOUND TRANSDUCER DRAPE
K970893 · Protek Medical Products, Inc. · Oct 1997
BEMISS JASON-STERILE,NON-STERILE,REINFORCED STERILE,AND REINFORCED NON-STERILE SURGICAL GOWN
K962666 · Bemiss-Jason Corp., Triad Medical Div. · Feb 1997
P1OP2B OR P1O92T
K954674 · Kay Borch A/S · Jan 1997
CONVERTORS POLYOLEFIN FABRIC GOWNS
K961341 · Baxter Healthcare Corp · Oct 1996
DEPUY STERILE VIEW BARRIER HOOD/GOWN WITH HYTREL
K961239 · Depuy, Inc. · Sep 1996
ROBISON & SMITH SURGICAL PACKS
K955586 · Robison & Smith, Inc. · Aug 1996