Cleared Traditional

K841789 - SECHRIST AIR-OXYGEN MIXER & ANCILLARY

K841789 is an FDA 510(k) clearance for SECHRIST AIR-OXYGEN MIXER & ANCILLARY, manufactured by Shiley, Inc.. The device is a Class 2 Anesthesiology device with product code BZR cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K841789 · Shiley, Inc. · Anesthesiology device
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Jul 1984
Decision
87d
Days
Class 2
Risk

K841789 is an FDA 510(k) clearance for the SECHRIST AIR-OXYGEN MIXER & ANCILLARY. Classified as Mixer, Breathing Gases, Anesthesia Inhalation (product code BZR), Class II - Special Controls.

Submitted by Shiley, Inc. (Walker, US). The FDA issued a Cleared decision on July 26, 1984 after a review of 87 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 Shiley, Inc. devices

FDA 510(k) Submission Details - K841789

510(k) Number K841789 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 1984
Decision Date July 26, 1984
Days to Decision 87 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
53d faster than avg
Panel avg: 140d · This submission: 87d
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 22
Devices cleared under the same product code (BZR) and FDA review panel - the closest regulatory comparables to K841789.
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
OHMEDA OXYGEN BLENDER
K853905 · Ohmeda Medical · Oct 1985
DOWNS CAP FLOW GENERATOR
K811393 · Vital Signs, Inc. · Jun 1981
SIEMENS-ELEMA AB O2-AIR MIXER 960
K800905 · Siemens Elema AB · May 1980
DRAGER ORMC
K800764 · Draeger Medical, Inc. · Apr 1980