Cleared Traditional

K180173 - Freespira

K180173 is the FDA 510(k) clearance for Freespira by Palo Alto Health Sciences, Inc.. It is a Class 2 Neurology device (product code HCC) cleared through the Traditional 510(k) pathway after a 213-day FDA review.

K180173 · Palo Alto Health Sciences, Inc. · Neurology device
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Aug 2018
Decision
213d
Days
Class 2
Risk

K180173 is an FDA 510(k) clearance for the Freespira. Classified as Device, Biofeedback (product code HCC), Class II - Special Controls.

Submitted by Palo Alto Health Sciences, Inc. (Kirkland, US). The FDA issued a Cleared decision on August 23, 2018 after a review of 213 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

Submission Details

510(k) Number K180173 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 2018
Decision Date August 23, 2018
Days to Decision 213 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
65d slower than avg
Panel avg: 148d · This submission: 213d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Consultant

Acknowledge Regulatory Strategies, LLC
Allison Komiyama

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HCC Device, Biofeedback

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