Cleared Traditional

K953815 - 5 LPM OXYGEN CONCENTRATOR

K953815 is an FDA 510(k) clearance for 5 LPM OXYGEN CONCENTRATOR, manufactured by Devilbiss Health Care, Inc.. The device is a Class 2 Anesthesiology device with product code CAW cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K953815 · Devilbiss Health Care, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1995
Decision
87d
Days
Class 2
Risk

K953815 is an FDA 510(k) clearance for the 5 LPM OXYGEN CONCENTRATOR. 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 Devilbiss Health Care, Inc. (Somerset, US). The FDA issued a Cleared decision on November 9, 1995 after a review of 87 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 Devilbiss Health Care, Inc. devices

FDA 510(k) Submission Details - K953815

510(k) Number K953815 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 1995
Decision Date November 09, 1995
Days to Decision 87 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 140d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 133
Devices cleared under the same product code (CAW) and FDA review panel - the closest regulatory comparables to K953815.
MODIFICATION TO VENTURE IHO 100 COMPLETE HOME OXYGEN SYSTEM
K983777 · Invacare Corp. · Dec 1998
CHAD TOTAL O2 DELIVERY SYSTEM
K971889 · Chad Therapeutics, Inc. · Nov 1997
AIRSEP NEWLIFE DUAL SIX OXYGEN CONCENTRATOR (MODIFICATION)
K960309 · Airsep Corp. · Feb 1997
ECO CHECK (ECOVALVE AND OXYGEN MONITOR)
K951882 · Airsep Corp. · Oct 1995
HUMIDIFIER & ACCESSORIES
K953949 · Fisher & Paykel Electronics , Ltd. · Oct 1995
3 LPM OXYGEN CONCENTRATOR
K952037 · Devilbiss Health Care, Inc. · Sep 1995