Cleared Traditional

K122223 - NEW: INTELLIVUE CL RESPIRATION POD NEW: SPECIALIZED ASSESSORY: MOBILE CL RESP ATTACHMENT MODIFIED: INTELLIVUE PATIENT MO

K122223 is an FDA 510(k) clearance for NEW: INTELLIVUE CL RESPIRATION POD NEW:..., manufactured by Philips Medizin Systeme Boeblingen GmbH. The device is a Class 2 Anesthesiology device with product code BZQ cleared through the Traditional 510(k) pathway after a 261-day FDA review.

K122223 · Philips Medizin Systeme Boeblingen GmbH · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2013
Decision
261d
Days
Class 2
Risk

K122223 is an FDA 510(k) clearance for the NEW: INTELLIVUE CL RESPIRATION POD NEW: SPECIALIZED ASSESSORY: MOBILE CL RESP.... Classified as Monitor, Breathing Frequency (product code BZQ), Class II - Special Controls.

Submitted by Philips Medizin Systeme Boeblingen GmbH (Boeblingen, DE). The FDA issued a Cleared decision on April 12, 2013 after a review of 261 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2375 - 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 Philips Medizin Systeme Boeblingen GmbH devices

FDA 510(k) Submission Details - K122223

510(k) Number K122223 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2012
Decision Date April 12, 2013
Days to Decision 261 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
121d slower than avg
Panel avg: 140d · This submission: 261d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZQ Device Classification - Class 2, Special Controls

Product Code BZQ Monitor, Breathing Frequency
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2375
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 - BZQ Monitor, Breathing Frequency

All 104
Devices cleared under the same product code (BZQ) and FDA review panel - the closest regulatory comparables to K122223.
INTELLIVUE CL RESPIRATION POD
K132320 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · Mar 2014
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EARLYSENSE
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EARLYSENSE (EVERON) SYSTEM
K120465 · Earlysense, Ltd. · Jun 2012
COVIDIEN NELLCOR RESPIRATION RATE SOFTWARE APPLICATION, VERSION 1.0
K111933 · Covidien · Mar 2012
SLEEPMINDER BREATHING FREQUENCY INDICATOR
K103631 · Biancamed Limited · Jul 2011