Cleared Traditional

K023693 - MOBILE PARTICULATE CONTAMINATION CONTROL SYSTEM, MODEL M-100

K023693 is an FDA 510(k) clearance for MOBILE PARTICULATE CONTAMINATION CONTRO..., manufactured by Airex, Inc.. The device is a Class 2 General Hospital device with product code FRF cleared through the Traditional 510(k) pathway after a 131-day FDA review.

K023693 · Airex, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2003
Decision
131d
Days
Class 2
Risk

K023693 is an FDA 510(k) clearance for the MOBILE PARTICULATE CONTAMINATION CONTROL SYSTEM, MODEL M-100. Classified as Cleaner, Air, Medical Recirculating (product code FRF), Class II - Special Controls.

Submitted by Airex, Inc. (Bellevue, US). The FDA issued a Cleared decision on March 12, 2003 after a review of 131 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5045 - the FDA general hospital 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K023693

510(k) Number K023693 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2002
Decision Date March 12, 2003
Days to Decision 131 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
2d slower than avg
Panel avg: 129d · This submission: 131d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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
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K023693 · MOBILE PARTICULATE CONTAMINATION CONTROL SYSTEM, MODEL M-100
Download PDF FDA Summary Airex, Inc.