Cleared Traditional

K925982 - BMD AIR/OXYGEN BLENDER

K925982 is an FDA 510(k) clearance for BMD AIR/OXYGEN BLENDER, manufactured by Biomedical Devices, Inc.. The device is a Class 2 Anesthesiology device with product code BZR cleared through the Traditional 510(k) pathway after a 316-day FDA review.

K925982 · Biomedical Devices, Inc. · Anesthesiology device
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Oct 1993
Decision
316d
Days
Class 2
Risk

K925982 is an FDA 510(k) clearance for the BMD AIR/OXYGEN BLENDER. Classified as Mixer, Breathing Gases, Anesthesia Inhalation (product code BZR), Class II - Special Controls.

Submitted by Biomedical Devices, Inc. (Madison, US). The FDA issued a Cleared decision on October 7, 1993 after a review of 316 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Biomedical Devices, Inc. devices

FDA 510(k) Submission Details - K925982

510(k) Number K925982 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 1992
Decision Date October 07, 1993
Days to Decision 316 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
176d slower than avg
Panel avg: 140d · This submission: 316d
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 43
Devices cleared under the same product code (BZR) and FDA review panel - the closest regulatory comparables to K925982.
AIR ENTRAINER 900RT008
K953711 · Fisher & Paykel Electronics , Ltd. · Nov 1995
OXY/STAR LOW FLOW BLENDER
K952878 · Infrasonics Corp. · Sep 1995
PRIMA HYUPERINFLATION SYSTEM
K952021 · Prima, Inc. · May 1995
MERIDIAN MEDICAL SYSTEMS HYPER INFLATION BAY SYST
K925591 · Merit Medical Systems, Inc. · Sep 1993
PRECISION MED PRODUCTS LTD HYPERINFLATION SYSTEM
K932709 · Precision Med Products, Ltd. · Jul 1993
HYPERINFLATION SYSTEM
K932557 · Life Shield Healthcare Products, Inc. · Jul 1993