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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
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 47
Devices cleared under the same product code (BZR) and FDA review panel - the closest regulatory comparables to K103317.
EQUINOX RELIEVE
K113687 · O-Two Medical Technologies, Inc. · Apr 2012
MAXMIXING BLOCK
K113232 · Maxtec, Inc. · Mar 2012
SEDARA GAS MIXER, SEDARA SCAVENGER MODEL: 03, 04
K101286 · Linde Healthcare AB · Oct 2011
HELIOX LOW FLOW SENTRY BLENDER
K092484 · Cardinal Health 207, Inc. · Apr 2010
HELIO2 BLENDER
K090781 · Precision Medical, Inc. · Aug 2009
TENACORE OXYGEN BLENDER, MODEL TB-2000
K081335 · Tenacore Holdings, Inc. · Nov 2008