Cleared Traditional

K853905 - OHMEDA OXYGEN BLENDER

K853905 is the FDA 510(k) clearance for OHMEDA OXYGEN BLENDER by Ohmeda Medical. It is a Class 2 Anesthesiology device (product code BZR) cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K853905 · Ohmeda Medical · Anesthesiology device

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Oct 1985

Decision

26d

Days

Class 2

Risk

K853905 is an FDA 510(k) clearance for the OHMEDA OXYGEN BLENDER. Classified as Mixer, Breathing Gases, Anesthesia Inhalation (product code BZR), Class II - Special Controls.

Submitted by Ohmeda Medical (Madison, US). The FDA issued a Cleared decision on October 16, 1985 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5330 - 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 Ohmeda Medical devices

Submission Details

510(k) Number	K853905 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 20, 1985
Decision Date	October 16, 1985
Days to Decision	26 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

114d faster than avg

Panel avg: 140d · This submission: 26d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code	BZR Mixer, Breathing Gases, Anesthesia Inhalation
Device Class	Class 2 - Special Controls
CFR Regulation	21 CFR 868.5330

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 - BZR Mixer, Breathing Gases, Anesthesia Inhalation

All 19

Devices cleared under the same product code (BZR) and FDA review panel - the closest regulatory comparables to K853905.

BIRD MICROBLENDER M.R.I.

K895695 · Bird Products Corp. · Jul 1990

P/N 9320 LOW FLOW AIR/OXYGEN MICROBLENDER

K883038 · Bird Products Corp. · Nov 1988

SIEMENS O2-AIR MIXER 965

K872278 · Siemens Elema AB · Sep 1987

SECHRIST AIR-OXYGEN MIXER & ANCILLARY

K841789 · Shiley, Inc. · Jul 1984

DOWNS CAP FLOW GENERATOR

K811393 · Vital Signs, Inc. · Jun 1981

SIEMENS-ELEMA AB O2-AIR MIXER 960

K800905 · Siemens Elema AB · May 1980

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 K853905

Ohmeda Medical

Madison, WI · US

RAYMOND T RIDDLE

Regulatory profile

120 submissions 118 cleared

98% clearance rate · Active in Anesthesiology

Data Intelligence Layer

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

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