Cleared Traditional

K090781 - HELIO2 BLENDER

K090781 is an FDA 510(k) clearance for HELIO2 BLENDER, manufactured by Precision Medical, Inc.. The device is a Class 2 Anesthesiology device with product code BZR cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K090781 · Precision Medical, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2009
Decision
143d
Days
Class 2
Risk

K090781 is an FDA 510(k) clearance for the HELIO2 BLENDER. Classified as Mixer, Breathing Gases, Anesthesia Inhalation (product code BZR), Class II - Special Controls.

Submitted by Precision Medical, Inc. (Northampton, US). The FDA issued a Cleared decision on August 13, 2009 after a review of 143 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.

View all Precision Medical, Inc. devices

FDA 510(k) Submission Details - K090781

510(k) Number K090781 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 2009
Decision Date August 13, 2009
Days to Decision 143 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
3d slower than avg
Panel avg: 140d · This submission: 143d
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 K090781.
SEDARA GAS MIXER, SEDARA SCAVENGER MODEL: 03, 04
K101286 · Linde Healthcare AB · Oct 2011
RESUSCITATION UNIT 105
K103317 · Atom Medical Corporation · Apr 2011
HELIOX LOW FLOW SENTRY BLENDER
K092484 · Cardinal Health 207, Inc. · Apr 2010
TENACORE OXYGEN BLENDER, MODEL TB-2000
K081335 · Tenacore Holdings, Inc. · Nov 2008
PRECISION BLENDER
K053232 · Precision Medical, Inc. · Jan 2006
PRAXAIR MEDICAL AIR MIXER
K051192 · Praxair, Inc. · Sep 2005