Cleared Traditional

K964354 - ARTOCOOL-S WATER CIRCULATING COLD PACK

K964354 is an FDA 510(k) clearance for ARTOCOOL-S WATER CIRCULATING COLD PACK, manufactured by Ormed GmbH. The device is a Class 2 Physical Medicine device with product code ILO cleared through the Traditional 510(k) pathway after a 302-day FDA review.

K964354 · Ormed GmbH · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1997
Decision
302d
Days
Class 2
Risk

K964354 is an FDA 510(k) clearance for the ARTOCOOL-S WATER CIRCULATING COLD PACK. Classified as Pack, Hot Or Cold, Water Circulating (product code ILO), Class II - Special Controls.

Submitted by Ormed GmbH (Concord, US). The FDA issued a Cleared decision on August 29, 1997 after a review of 302 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5720 - 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Ormed GmbH devices

FDA 510(k) Submission Details - K964354

510(k) Number K964354 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 1996
Decision Date August 29, 1997
Days to Decision 302 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
187d slower than avg
Panel avg: 115d · This submission: 302d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ILO Device Classification - Class 2, Special Controls

Product Code ILO Pack, Hot Or Cold, Water Circulating
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5720
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 Physical Medicine devices follow this clearance model.

Regulatory Peers - ILO Pack, Hot Or Cold, Water Circulating

All 34
Devices cleared under the same product code (ILO) and FDA review panel - the closest regulatory comparables to K964354.
MODIFICATION TO POLAR CARE 500
K070402 · Breg, Inc. · Mar 2007
INCARE HOT/ICE SYSTEM FOOT/ANKLE BLANKET
K973023 · Hollister, Inc. · Nov 1997
HTP-1500 LOCALIZED HEAT THERAPY PUMP
K970197 · Adroit Medical Systems, Inc. · Sep 1997
ARTROTHERM CRYOTHERAPY AND THERNOTHERAPY
K964799 · Ormed GmbH · Aug 1997
BLEDSOE COLD CONTROL
K964710 · Med Technology, Inc. · May 1997
MODEL 1100 COLD THERAPY DEVICE
K970533 · Smith & Nephew, Inc. · Apr 1997