Cleared Traditional

K952878 - OXY/STAR LOW FLOW BLENDER

K952878 is an FDA 510(k) clearance for OXY/STAR LOW FLOW BLENDER, manufactured by Infrasonics Corp.. The device is a Class 2 Anesthesiology device with product code BZR cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K952878 · Infrasonics Corp. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 1995
Decision
94d
Days
Class 2
Risk

K952878 is an FDA 510(k) clearance for the OXY/STAR LOW FLOW BLENDER. Classified as Mixer, Breathing Gases, Anesthesia Inhalation (product code BZR), Class II - Special Controls.

Submitted by Infrasonics Corp. (San Diego, US). The FDA issued a Cleared decision on September 25, 1995 after a review of 94 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K952878

510(k) Number K952878 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 1995
Decision Date September 25, 1995
Days to Decision 94 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 140d · This submission: 94d
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 48
Devices cleared under the same product code (BZR) and FDA review panel - the closest regulatory comparables to K952878.
AIR OXYGE MIXER
K974372 · Sk Med · Feb 1998
ALADDIN MONITORING OXYGEN/AIR MIXER
K960359 · Hamilton Medical, Inc. · Apr 1996
AIR ENTRAINER 900RT008
K953711 · Fisher & Paykel Electronics , Ltd. · Nov 1995
PRIMA HYUPERINFLATION SYSTEM
K952021 · Prima, Inc. · May 1995
BABYCARE NEO2 OXYGEN CONCENTRATION CONTROLLER
K943797 · Bpr Medical, Ltd. · May 1995
BMD AIR/OXYGEN BLENDER
K925982 · Biomedical Devices, Inc. · Oct 1993
K952878 · OXY/STAR LOW FLOW BLENDER
Download PDF FDA Summary Infrasonics Corp.