Cleared Traditional

K131586 - CANARY BREATHING SYSTEM

K131586 is an FDA 510(k) clearance for CANARY BREATHING SYSTEM, manufactured by Palo Alto Health Sciences, Inc.. The device is a Class 2 Neurology device with product code HCC cleared through the Traditional 510(k) pathway after a 193-day FDA review.

K131586 · Palo Alto Health Sciences, Inc. · Neurology device
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Dec 2013
Decision
193d
Days
Class 2
Risk

K131586 is an FDA 510(k) clearance for the CANARY BREATHING SYSTEM. Classified as Device, Biofeedback (product code HCC), Class II - Special Controls.

Submitted by Palo Alto Health Sciences, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on December 10, 2013 after a review of 193 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5050 - the FDA neurology 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 Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Palo Alto Health Sciences, Inc. devices

FDA 510(k) Submission Details - K131586

510(k) Number K131586 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 2013
Decision Date December 10, 2013
Days to Decision 193 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
45d slower than avg
Panel avg: 148d · This submission: 193d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HCC Device Classification - Class 2, Special Controls

Product Code HCC Device, Biofeedback
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5050
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 Neurology devices follow this clearance model.

Regulatory Peers - HCC Device, Biofeedback

All 53
Devices cleared under the same product code (HCC) and FDA review panel - the closest regulatory comparables to K131586.
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EEGER4 MODEL 4.3
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EMG SYSTEM
K111687 · Myotronics-Noromed, Inc. · Sep 2011
POLYGRAM NET BIOFEEDBACK APPLICATION
K041244 · Medtronic Vascular · Aug 2004