Cleared Traditional

K073242 - PORTABLE OXYGEN CONCENTRATOR

K073242 is an FDA 510(k) clearance for PORTABLE OXYGEN CONCENTRATOR, manufactured by Delphi Medical Systems. The device is a Class 2 Anesthesiology device with product code CAW cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K073242 · Delphi Medical Systems · Anesthesiology device
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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

FDA 510(k) Submission Details - K073242

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.

CAW Device Classification - Class 2, Special Controls

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 121
Devices cleared under the same product code (CAW) and FDA review panel - the closest regulatory comparables to K073242.
INVACARE TPOC PORTABLE CONCENTRATOR, MODEL TPOC100
K083751 · Invacare Corporation · May 2009
PRECISION OXYGEN CONCENTRATOR
K072348 · Precision Medical, Inc. · Oct 2008
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
MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS
K053230 · Merits Health Products Co., Ltd. · May 2006