Cleared Traditional

K960309 - AIRSEP NEWLIFE DUAL SIX OXYGEN CONCENTRATOR (MODIFICATION)

K960309 is an FDA 510(k) clearance for AIRSEP NEWLIFE DUAL SIX OXYGEN CONCENTR..., manufactured by Airsep Corp.. The device is a Class 2 Anesthesiology device with product code CAW cleared through the Traditional 510(k) pathway after a 420-day FDA review.

K960309 · Airsep Corp. · Anesthesiology device
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Feb 1997
Decision
420d
Days
Class 2
Risk

K960309 is an FDA 510(k) clearance for the AIRSEP NEWLIFE DUAL SIX OXYGEN CONCENTRATOR (MODIFICATION). 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 Airsep Corp. (Buffalo, US). The FDA issued a Cleared decision on February 28, 1997 after a review of 420 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Airsep Corp. devices

FDA 510(k) Submission Details - K960309

510(k) Number K960309 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 1996
Decision Date February 28, 1997
Days to Decision 420 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
280d slower than avg
Panel avg: 140d · This submission: 420d
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 214
Devices cleared under the same product code (CAW) and FDA review panel - the closest regulatory comparables to K960309.
INNOSAN TRAVELAIR S PLUS PORTABLE OXYGEN CONCENTRATOR, CODE NO. M407001853 (WITH AC POWER SUPPLY ACCESSORY)
K971947 · Sim Italia S.R.L. · Oct 1997
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K971964 · Oxlife, Inc. · Aug 1997
OXYPURE PORTABLE OXYGEN GENERATOR
K971129 · Arbor Research Corp. · Jun 1997
INNOSAN TRAVELAIR S PORTABLE OXYGEN CONCENTRATOR, CODE NO. M407001853
K963042 · Sim Italia S.R.L. · Nov 1996
EMOX
K954506 · Medtrak Intl., Inc. · Apr 1996
OXLIFE OXYGEN CONCENTRATORS
K955549 · Oxlife, Inc. · Mar 1996