Cleared Traditional

K103317 - RESUSCITATION UNIT 105

K103317 is an FDA 510(k) clearance for RESUSCITATION UNIT 105, manufactured by Atom Medical Corporation. The device is a Class 2 Anesthesiology device with product code BZR cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K103317 · Atom Medical Corporation · Anesthesiology device
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Apr 2011
Decision
161d
Days
Class 2
Risk

K103317 is an FDA 510(k) clearance for the RESUSCITATION UNIT 105. Classified as Mixer, Breathing Gases, Anesthesia Inhalation (product code BZR), Class II - Special Controls.

Submitted by Atom Medical Corporation (Bonita Springs, US). The FDA issued a Cleared decision on April 20, 2011 after a review of 161 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 Atom Medical Corporation devices

FDA 510(k) Submission Details - K103317

510(k) Number K103317 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 10, 2010
Decision Date April 20, 2011
Days to Decision 161 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d slower than avg
Panel avg: 140d · This submission: 161d
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 K103317.
Quality Mix Blender, Oxymixer
K221494 · Dehas Medical Systems GmbH · Jan 2023
Nitronox Plus 0-70, Nitronox 0-50, Nitronox Plus 50/50
K202480 · Parker Hannifin · Apr 2021
Equinox Advantage
K173205 · O-Two Medical Technologies, Inc. · Aug 2018
HELIO2 BLENDER
K090781 · Precision Medical, Inc. · Aug 2009
PRECISION BLENDER
K053232 · Precision Medical, Inc. · Jan 2006
SECHRIST AIR-OXYGEN MIXER, 3500/3500HL SERIES
K992503 · Sechrist Industries, Inc. · Aug 1999