Cleared Traditional

K915381 - PORTABLE OXYGEN GENERATOR

K915381 is an FDA 510(k) clearance for PORTABLE OXYGEN GENERATOR, manufactured by Aequitron Medical, Inc.. 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.

K915381 · Aequitron Medical, Inc. · Anesthesiology device
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Mar 1992
Decision
103d
Days
Class 2
Risk

K915381 is an FDA 510(k) clearance for the PORTABLE OXYGEN GENERATOR. 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 Aequitron Medical, Inc. (Plymouth, US). The FDA issued a Cleared decision on March 11, 1992 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 Aequitron Medical, Inc. devices

FDA 510(k) Submission Details - K915381

510(k) Number K915381 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 1991
Decision Date March 11, 1992
Days to Decision 103 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
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 132
Devices cleared under the same product code (CAW) and FDA review panel - the closest regulatory comparables to K915381.
OH-500 OXYGEN CONCENTRATOR
K924146 · Healthdyne, Inc. · Jan 1993
ALPINE V
K914916 · Mountain Medical Equipment, Inc. · Sep 1992
MODELS: IRCRF5, IRCPF16 FLOWMETER ACCESSORY KITS
K914488 · Invacare Corp. · Sep 1992
MOBILAIRE III AND V MODEL IRC 301 AND 501 OXY. CON
K904087 · Invacare Corp. · Oct 1990
V-LINK
K903608 · GE Medical Systems · Oct 1990
ASPEN 3 OXYGEN CONCENTRATOR
K902890 · Mountain Medical Equipment, Inc. · Jul 1990