Cleared Traditional

K890150 - H-3000 OXYGEN CONCENTRATOR

K890150 is the FDA 510(k) clearance for H-3000 OXYGEN CONCENTRATOR by Healthdyne, Inc.. It is a Class 2 Anesthesiology device (product code CAW) cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K890150 · Healthdyne, Inc. · Anesthesiology device

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Jan 1989

Decision

18d

Days

Class 2

Risk

K890150 is an FDA 510(k) clearance for the H-3000 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 Healthdyne, Inc. (Marietta, US). The FDA issued a Cleared decision on January 31, 1989 after a review of 18 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 Healthdyne, Inc. devices

Submission Details

510(k) Number	K890150 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 13, 1989
Decision Date	January 31, 1989
Days to Decision	18 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	-
Third-party Review	No - reviewed directly by FDA

Regulatory Context

Review time vs. panel average

122d faster than avg

Panel avg: 140d · This submission: 18d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

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 67

Devices cleared under the same product code (CAW) and FDA review panel - the closest regulatory comparables to K890150.

PURITAN-BENNETT OXYGEN CONCENTRATION INDICATOR

K895177 · Puritan Bennett Corp. · Nov 1989

MODEL 590 OXYGEN CONCENTRATOR

K895141 · Puritan Bennett Corp. · Oct 1989

MOBILAIRE V OXYGEN CONCENTRATOR

K891488 · Invacare Corp. · May 1989

MOBILAIRE III P3 OXYGEN CONCENTRATOR

K851434 · Invacare Corp. · Jul 1985

PRIME AIRE O, MODEL PA02 2 O OXYGEN CONCENTRATOR

K851435 · Invacare Corp. · Jul 1985

PRIME AIRE O2 PLUS 2

K851437 · Invacare Corp. · Jul 1985

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K890150

Healthdyne, Inc.

Marietta, GA · US

TIM COWART

Regulatory profile

35 submissions 35 cleared

100% clearance rate · Active in Anesthesiology

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Sourced from FDA 510(k) public files . Updated monthly.

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