Cleared Traditional

K000653 - AERONOX UNIVERSAL, MODEL P/N 360000, AERONOX BEDSIDE, MODEL P/N 360001, AERONOX TRANSPORT TRANSPORT, MODEL P/N 360002

K000653 is an FDA 510(k) clearance for AERONOX UNIVERSAL, manufactured by Pulmonox Medical Corp.. The device is a Class 2 Anesthesiology device with product code MRN cleared through the Traditional 510(k) pathway after a 158-day FDA review.

K000653 · Pulmonox Medical Corp. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2000
Decision
158d
Days
Class 2
Risk

K000653 is an FDA 510(k) clearance for the AERONOX UNIVERSAL, MODEL P/N 360000, AERONOX BEDSIDE, MODEL P/N 360001, AERON.... Classified as Apparatus, Nitric Oxide Delivery (product code MRN), Class II - Special Controls.

Submitted by Pulmonox Medical Corp. (Tofield, Alberta, CA). The FDA issued a Cleared decision on August 4, 2000 after a review of 158 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5165 - the FDA anesthesiology and respiratory 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 Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Pulmonox Medical Corp. devices

FDA 510(k) Submission Details - K000653

510(k) Number K000653 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 2000
Decision Date August 04, 2000
Days to Decision 158 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d slower than avg
Panel avg: 140d · This submission: 158d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MRN Device Classification - Class 2, Special Controls

Product Code MRN Apparatus, Nitric Oxide Delivery
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5165
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 Anesthesiology devices follow this clearance model.

Regulatory Peers - MRN Apparatus, Nitric Oxide Delivery

All 23
Devices cleared under the same product code (MRN) and FDA review panel - the closest regulatory comparables to K000653.
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INOMAX DSIR (DELIVERY SYSTEM)
K110344 · Ino Therapeutics · Jun 2011
INOMAX DS(IR) (DELIVERY SYSTEM)
K110635 · Ino Therapeutics, LLC/Dba Ikaria · Jun 2011
DATEX-OHMEDA INOVENT DELIVERY SYSTEM
K000186 · Datex-Ohmeda · Feb 2000
OHMEDA INOVENT DELIVERY SYSTEM
DEN000001 · Ohmeda Medical · Jan 2000