Cleared Traditional

K991722 - DEVILBISS 5 LITER OXYGEN CONCENTRATOR

K991722 is an FDA 510(k) clearance for DEVILBISS 5 LITER OXYGEN CONCENTRATOR, manufactured by Sunrise Medical Hhg, Inc.. The device is a Class 2 Anesthesiology device with product code CAW cleared through the Traditional 510(k) pathway after a 167-day FDA review.

K991722 · Sunrise Medical Hhg, Inc. · Anesthesiology device
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Nov 1999
Decision
167d
Days
Class 2
Risk

K991722 is an FDA 510(k) clearance for the DEVILBISS 5 LITER 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 Sunrise Medical Hhg, Inc. (Somerset, US). The FDA issued a Cleared decision on November 3, 1999 after a review of 167 days - an extended review 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: 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 Sunrise Medical Hhg, Inc. devices

FDA 510(k) Submission Details - K991722

510(k) Number K991722 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 1999
Decision Date November 03, 1999
Days to Decision 167 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
27d slower than avg
Panel avg: 140d · This submission: 167d
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 143
Devices cleared under the same product code (CAW) and FDA review panel - the closest regulatory comparables to K991722.
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TOTAL O2
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VENTURE IHO 100 HOME FILL COMPLETE HOME OXYGEN SYSTEM
K983627 · Invacare Corp. · Oct 1999
PURITAN-BENNETT AERIS 590 OXYGEN CONCENTRATOR WITH OCI
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FRESH AIR
K981047 · Colorado Medtech, Inc. · Sep 1999