Cleared Traditional

K895177 - PURITAN-BENNETT OXYGEN CONCENTRATION IN...

K895177 is an FDA 510(k) clearance for PURITAN-BENNETT OXYGEN CONCENTRATION IN..., manufactured by Puritan Bennett Corp.. The device is a Class 2 Anesthesiology device with product code CAW cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K895177 · Puritan Bennett Corp. · Anesthesiology device
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Nov 1989
Decision
103d
Days
Class 2
Risk

K895177 is an FDA 510(k) clearance for the PURITAN-BENNETT OXYGEN CONCENTRATION INDICATOR. 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. (Overland Park, US). The FDA issued a Cleared decision on November 21, 1989 after a review of 103 days - within the typical 510(k) review window.

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 Puritan Bennett Corp. devices

FDA 510(k) Submission Details - K895177

510(k) Number K895177 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 1989
Decision Date November 21, 1989
Days to Decision 103 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 140d · This submission: 103d
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 91
Devices cleared under the same product code (CAW) and FDA review panel - the closest regulatory comparables to K895177.
MOBILAIRE III AND V MODEL IRC 301 AND 501 OXY. CON
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K896457 · Devilbiss Health Care, Inc. · Feb 1990
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K895141 · Puritan Bennett Corp. · Oct 1989
MOBILAIRE V OXYGEN CONCENTRATOR
K891488 · Invacare Corp. · May 1989
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K890150 · Healthdyne, Inc. · Jan 1989