Cleared Special

K010616 - DEFENDER ROOM AIR CLEANER, MODEL RAC-4000A

K010616 is an FDA 510(k) clearance for DEFENDER ROOM AIR CLEANER, manufactured by Hmi Industries, Inc.. The device is a Class 2 General Hospital device with product code FRF cleared through the Special 510(k) pathway after a 27-day FDA review.

K010616 · Hmi Industries, Inc. · General Hospital
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Mar 2001
Decision
27d
Days
Class 2
Risk

K010616 is an FDA 510(k) clearance for the DEFENDER ROOM AIR CLEANER, MODEL RAC-4000A. Classified as Cleaner, Air, Medical Recirculating (product code FRF), Class II - Special Controls.

Submitted by Hmi Industries, Inc. (Strongville, US). The FDA issued a Cleared decision on March 28, 2001 after a review of 27 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5045 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K010616

510(k) Number K010616 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2001
Decision Date March 28, 2001
Days to Decision 27 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 129d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

FRF Device Classification - Class 2, Special Controls

Product Code FRF Cleaner, Air, Medical Recirculating
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5045
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 - FRF Cleaner, Air, Medical Recirculating

All 52
Devices cleared under the same product code (FRF) and FDA review panel - the closest regulatory comparables to K010616.
PLASMAIR, MODEL T2006
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K023693 · Airex, Inc. · Mar 2003
ADVANCED AIR PURIFICATION SYSTEM
K012549 · Healthway Products, Inc. · Feb 2002
DEFENDER ROOM AIR CLEANER, MODEL RAC-3000A
K002692 · Hmi Industries, Inc. · Nov 2000
HEPA-CARE AIR CLEANER AMERICAN AIR FILTER AIR FILTRATION SYSTEM MODELS HC800F, HFS800F, HC800C/ HFS800C, HC400C/HFS400C
K984116 · Abatement Technologies, Inc. · Jun 1999
BREATHE EASY, MODELS AD AND CD
K981841 · Respiraid , Ltd. · Oct 1998
K010616 · DEFENDER ROOM AIR CLEANER, MODEL RAC-4000A
Download PDF Hmi Industries, Inc.