Cleared Traditional

K945467 - BABYTHERM 8000 WB

K945467 is an FDA 510(k) clearance for BABYTHERM 8000 WB, manufactured by Drager, Inc.. The device is a Class 2 Physical Medicine device with product code ILO cleared through the Traditional 510(k) pathway after a 172-day FDA review.

K945467 · Drager, Inc. · Physical Medicine device
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Apr 1995
Decision
172d
Days
Class 2
Risk

K945467 is an FDA 510(k) clearance for the BABYTHERM 8000 WB. Classified as Pack, Hot Or Cold, Water Circulating (product code ILO), Class II - Special Controls.

Submitted by Drager, Inc. (Chantilly, US). The FDA issued a Cleared decision on April 28, 1995 after a review of 172 days - an extended review cycle.

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. Standard predicate reliance. 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 Drager, Inc. devices

FDA 510(k) Submission Details - K945467

510(k) Number K945467 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 1994
Decision Date April 28, 1995
Days to Decision 172 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
57d slower than avg
Panel avg: 115d · This submission: 172d
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 26
Devices cleared under the same product code (ILO) and FDA review panel - the closest regulatory comparables to K945467.
EBI THERMAL THERAPY SYSTEM
K963261 · Electro-Biology, Inc. · Sep 1996
EBICE
K953532 · Electro-Biology, Inc. · Oct 1995
THERMOCOOL SYSTEM
K950395 · Zimmer, Inc. · Aug 1995
EBICE
K945067 · Electro-Biology, Inc. · Feb 1995
INCARE HOT/ICE COLD THERAPY COOLER
K944971 · Hollister, Inc. · Jan 1995
HOT/ICE SYSTEM STERILE CONFORMABLE/DISP. BLANKETS
K931843 · Hollister, Inc. · Feb 1994