Cleared Traditional

PORTABLE OXYGEN CONCENTRATOR, MODEL RS-00400 (K073242) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K073242 · Delphi Medical Systems · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2008
Decision
45d
Days
Class 2
Risk

K073242 is an FDA 510(k) clearance for the PORTABLE OXYGEN CONCENTRATOR, MODEL RS-00400. Classified as Generator, Oxygen, Portable within the CAW classification (a category for home-use oxygen therapy and respiratory devices), Class II - Special Controls.

Submitted by Delphi Medical Systems (Troy, US). The FDA issued a Cleared decision on January 3, 2008 after a review of 45 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5440 - 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: 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 Delphi Medical Systems devices

Submission Details

510(k) Number K073242 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 2007
Decision Date January 03, 2008
Days to Decision 45 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 140d · This submission: 45d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code CAW Generator, Oxygen, Portable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5440
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 - CAW Generator, Oxygen, Portable

All 67
Devices cleared under the same product code (CAW) and FDA review panel - the closest regulatory comparables to K073242.
SIMPLYGO PORTABLE OXYGEN CONCENTRATOR
K111885 · Respironics, Inc. · Nov 2011
OMNI 5 TOTAL O2 DELIVERY SYSTEM
K091028 · Respironics, Inc. · Jul 2009
HOMELOX
K081206 · Respironics, Inc. · Jul 2008
THE INVACARE FLYER, MODEL IPC 100
K071928 · Invacare Corp. · Dec 2007
L4 OXYGEN CONCENTRATOR
K061261 · Respironics, Inc. · Jun 2006
MILLENNIUM M10 OXYGEN CONCENTRATOR, MODEL M10600
K043006 · Respironics, Inc. · Feb 2005