Cleared Traditional

K844328 - OXYGEN CONCENTRATOR

K844328 is an FDA 510(k) clearance for OXYGEN CONCENTRATOR, manufactured by Hospitak, Inc.. The device is a Class 2 Anesthesiology device with product code CAW cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K844328 · Hospitak, Inc. · Anesthesiology device
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Dec 1984
Decision
27d
Days
Class 2
Risk

K844328 is an FDA 510(k) clearance for the OXYGEN CONCENTRATOR. 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 Hospitak, Inc. (Lindenhurst, US). The FDA issued a Cleared decision on December 4, 1984 after a review of 27 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Hospitak, Inc. devices

FDA 510(k) Submission Details - K844328

510(k) Number K844328 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 1984
Decision Date December 04, 1984
Days to Decision 27 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
113d faster than avg
Panel avg: 140d · This submission: 27d
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 K844328.
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
COMPANION 492 OXYGEN CONCENTRATOR
K843243 · Puritan Bennett Corp. · Aug 1984
CRITERION I
K834274 · Timeter Instrument Corp. · Apr 1984
CATALOG 6400 OXYGEN CONCENTRATOR
K833938 · Hudson Oxygen Therapy Sales Co. · Dec 1983