Cleared Traditional

K943797 - BABYCARE NEO2 OXYGEN CONCENTRATION CONT...

K943797 is an FDA 510(k) clearance for BABYCARE NEO2 OXYGEN CONCENTRATION CONT..., manufactured by Bpr Medical, Ltd.. The device is a Class 2 Anesthesiology device with product code BZR cleared through the Traditional 510(k) pathway after a 281-day FDA review.

K943797 · Bpr Medical, Ltd. · Anesthesiology device
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May 1995
Decision
281d
Days
Class 2
Risk

K943797 is an FDA 510(k) clearance for the BABYCARE NEO2 OXYGEN CONCENTRATION CONTROLLER. Classified as Mixer, Breathing Gases, Anesthesia Inhalation (product code BZR), Class II - Special Controls.

Submitted by Bpr Medical, Ltd. (Mansfield, Notts. England, GB). The FDA issued a Cleared decision on May 11, 1995 after a review of 281 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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 Bpr Medical, Ltd. devices

FDA 510(k) Submission Details - K943797

510(k) Number K943797 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 1994
Decision Date May 11, 1995
Days to Decision 281 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
141d slower than avg
Panel avg: 140d · This submission: 281d
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 27
Devices cleared under the same product code (BZR) and FDA review panel - the closest regulatory comparables to K943797.
BIRD SENTRY BLENDER/ ANALYZER / BIRD SENTRY LOW FLOW BLENDER/ANALYZER
K973646 · Bird Products Corp. · May 1998
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
BIRD SENTRY AIR/OXYGEN MICROBLENDER
K911962 · Bird Products Corp. · Oct 1991
LOW FLOW N2O/02O MICROBLENDER
K900722 · Bird Products Corp. · Jul 1990