Cleared Special

K993088 - PURITAN-BENNETT AERIS 590 OXYGEN CONCEN...

K993088 is an FDA 510(k) clearance for PURITAN-BENNETT AERIS 590 OXYGEN CONCEN..., manufactured by Puritan Bennett Corp.. The device is a Class 2 Anesthesiology device with product code CAW cleared through the Special 510(k) pathway after a 22-day FDA review.

K993088 · Puritan Bennett Corp. · Anesthesiology device
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Oct 1999
Decision
22d
Days
Class 2
Risk

K993088 is an FDA 510(k) clearance for the PURITAN-BENNETT AERIS 590 OXYGEN CONCENTRATOR WITH OCI. 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 Puritan Bennett Corp. (Carlsbad, US). The FDA issued a Cleared decision on October 8, 1999 after a review of 22 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Puritan Bennett Corp. devices

FDA 510(k) Submission Details - K993088

510(k) Number K993088 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 1999
Decision Date October 08, 1999
Days to Decision 22 days
Submission Type Special
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
118d faster than avg
Panel avg: 140d · This submission: 22d
Pathway characteristics
Modification to existing cleared device.

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 91
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