Cleared Traditional

K103631 - SLEEPMINDER BREATHING FREQUENCY INDICATOR

K103631 is an FDA 510(k) clearance for SLEEPMINDER BREATHING FREQUENCY INDICATOR, manufactured by Biancamed Limited. The device is a Class 2 Anesthesiology device with product code BZQ cleared through the Traditional 510(k) pathway after a 220-day FDA review.

K103631 · Biancamed Limited · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2011
Decision
220d
Days
Class 2
Risk

K103631 is an FDA 510(k) clearance for the SLEEPMINDER BREATHING FREQUENCY INDICATOR. Classified as Monitor, Breathing Frequency (product code BZQ), Class II - Special Controls.

Submitted by Biancamed Limited (Belfield, Dublin, IE). The FDA issued a Cleared decision on July 21, 2011 after a review of 220 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.

FDA 510(k) Submission Details - K103631

510(k) Number K103631 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 2010
Decision Date July 21, 2011
Days to Decision 220 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
80d slower than avg
Panel avg: 140d · This submission: 220d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Anesthesiology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT01319396 Completed Observational Industry-sponsored

Performance Validation of a Non-contact Breathing Frequency Monitor (Model BM07)

24
Patients (actual)
1
Site
Condition studied Unspecified Threat to Breathing
Eligibility All sexes · 10 Years+ · Healthy volunteers accepted
Principal investigator Paul D Phillips, MSc, MA
Sponsor ResMed (industry)
Started 2010-10-01 → Primary completion 2010-12-01 → Completed 2011-03-01
Primary outcome
Respiration Rate Accuracy - Mean Difference in Breaths Per Minute Between the BM07 5GHz Sensor and SomnoScreen Devices
View full study on ClinicalTrials.gov

Regulatory Peers - BZQ Monitor, Breathing Frequency

All 119
Devices cleared under the same product code (BZQ) and FDA review panel - the closest regulatory comparables to K103631.
NEW: INTELLIVUE CL RESPIRATION POD NEW: SPECIALIZED ASSESSORY: MOBILE CL RESP ATTACHMENT MODIFIED: INTELLIVUE PATIENT MO
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EARLYSENSE (EVERON) SYSTEM
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COVIDIEN NELLCOR RESPIRATION RATE SOFTWARE APPLICATION, VERSION 1.0
K111933 · Covidien · Mar 2012
KAI SPOT MODEL KMS 200
K100773 · Kai Medical, Inc. · Jun 2010
EVERON 1.0
K092062 · Earlysense, Ltd. · May 2010
PNEUMOTHERML, MODEL: 5800
K092685 · Salter Labs · Nov 2009
K103631 · SLEEPMINDER BREATHING FREQUENCY INDICATOR
Download PDF FDA Summary Biancamed Limited