Cleared Traditional

K934262 - HPRH HOSPITAL PATIENT RADIANT HEATER

K934262 is an FDA 510(k) clearance for HPRH HOSPITAL PATIENT RADIANT HEATER, manufactured by Marley Electric Heating Co.. The device is a Class 2 Physical Medicine device with product code ILO cleared through the Traditional 510(k) pathway after a 595-day FDA review.

K934262 · Marley Electric Heating Co. · Physical Medicine device
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Apr 1995
Decision
595d
Days
Class 2
Risk

K934262 is an FDA 510(k) clearance for the HPRH HOSPITAL PATIENT RADIANT HEATER. Classified as Pack, Hot Or Cold, Water Circulating (product code ILO), Class II - Special Controls.

Submitted by Marley Electric Heating Co. (Bennettsville, US). The FDA issued a Cleared decision on April 18, 1995 after a review of 595 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Physical Medicine submissions.

View all Marley Electric Heating Co. devices

FDA 510(k) Submission Details - K934262

510(k) Number K934262 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received August 31, 1993
Decision Date April 18, 1995
Days to Decision 595 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
480d slower than avg
Panel avg: 115d · This submission: 595d
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 43
Devices cleared under the same product code (ILO) and FDA review panel - the closest regulatory comparables to K934262.
EBICE
K953532 · Electro-Biology, Inc. · Oct 1995
THERMOCOOL SYSTEM
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BABYTHERM 8000 WB
K945467 · Drager, Inc. · Apr 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