Cleared Traditional

K902664 - HOSPITAL/HOME ENVIRONMENTAL CONTROL SYST/HECS-1

K902664 is an FDA 510(k) clearance for HOSPITAL/HOME ENVIRONMENTAL CONTROL SYS..., manufactured by Prentke Romich Co.. The device is a Class 2 Physical Medicine device with product code IQA cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K902664 · Prentke Romich Co. · Physical Medicine device
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Jul 1990
Decision
37d
Days
Class 2
Risk

K902664 is an FDA 510(k) clearance for the HOSPITAL/HOME ENVIRONMENTAL CONTROL SYST/HECS-1. Classified as System, Environmental Control, Powered (product code IQA), Class II - Special Controls.

Submitted by Prentke Romich Co. (Wooster, US). The FDA issued a Cleared decision on July 25, 1990 after a review of 37 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3725 - 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: 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 Prentke Romich Co. devices

FDA 510(k) Submission Details - K902664

510(k) Number K902664 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 1990
Decision Date July 25, 1990
Days to Decision 37 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
78d faster than avg
Panel avg: 115d · This submission: 37d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IQA Device Classification - Class 2, Special Controls

Product Code IQA System, Environmental Control, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.3725
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.