Cleared Traditional

K872278 - SIEMENS O2-AIR MIXER 965

K872278 is an FDA 510(k) clearance for SIEMENS O2-AIR MIXER 965, manufactured by Siemens Elema AB. The device is a Class 2 Anesthesiology device with product code BZR cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K872278 · Siemens Elema AB · Anesthesiology device
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Sep 1987
Decision
80d
Days
Class 2
Risk

K872278 is an FDA 510(k) clearance for the SIEMENS O2-AIR MIXER 965. Classified as Mixer, Breathing Gases, Anesthesia Inhalation (product code BZR), Class II - Special Controls.

Submitted by Siemens Elema AB (Schaumburg, US). The FDA issued a Cleared decision on September 3, 1987 after a review of 80 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 Siemens Elema AB devices

FDA 510(k) Submission Details - K872278

510(k) Number K872278 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 1987
Decision Date September 03, 1987
Days to Decision 80 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
60d faster than avg
Panel avg: 140d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZR Device Classification - Class 2, Special Controls

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 21
Devices cleared under the same product code (BZR) and FDA review panel - the closest regulatory comparables to K872278.
LOW FLOW N2O/02O MICROBLENDER
K900722 · Bird Products Corp. · Jul 1990
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
OHMEDA OXYGEN BLENDER
K853905 · Ohmeda Medical · Oct 1985
SECHRIST AIR-OXYGEN MIXER & ANCILLARY
K841789 · Shiley, Inc. · Jul 1984
DOWNS CAP FLOW GENERATOR
K811393 · Vital Signs, Inc. · Jun 1981