Cleared Traditional

K851437 - PRIME AIRE O2 PLUS 2

K851437 is an FDA 510(k) clearance for PRIME AIRE O2 PLUS 2, manufactured by Invacare Corp.. The device is a Class 2 Anesthesiology device with product code CAW cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K851437 · Invacare Corp. · Anesthesiology device
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Jul 1985
Decision
110d
Days
Class 2
Risk

K851437 is an FDA 510(k) clearance for the PRIME AIRE O2 PLUS 2. 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 Invacare Corp. (Elyria, US). The FDA issued a Cleared decision on July 29, 1985 after a review of 110 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 Invacare Corp. devices

FDA 510(k) Submission Details - K851437

510(k) Number K851437 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 1985
Decision Date July 29, 1985
Days to Decision 110 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
30d faster than avg
Panel avg: 140d · This submission: 110d
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 K851437.
OXYGEN CONCENTRATOR, MODEL BX-5000
K854374 · Healthdyne, Inc. · Jan 1986
MOBILAIRE III P3 OXYGEN CONCENTRATOR
K851434 · Invacare Corp. · Jul 1985
PRIME AIRE O, MODEL PA02 2 O OXYGEN CONCENTRATOR
K851435 · Invacare Corp. · Jul 1985
MOBILAIRE II(P2A) OXYGEN CONCENTRATOR
K851438 · Invacare Corp. · Jul 1985
MOBILAIRE, PLA-01 OXYGEN CONCENTRATOR
K851439 · Invacare Corp. · Jul 1985
PREMIER O2 OXYGEN CONCENTRATOR
K844223 · Everest & Jennings, Inc. · Dec 1984