Cleared Traditional

K163448 - GrindCare System

K163448 is an FDA 510(k) clearance for GrindCare System, manufactured by Sunstar Suisse S.A.. The device is a Class 2 Neurology device with product code HCC cleared through the Traditional 510(k) pathway after a 267-day FDA review.

K163448 · Sunstar Suisse S.A. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2017
Decision
267d
Days
Class 2
Risk

K163448 is an FDA 510(k) clearance for the GrindCare System. Classified as Device, Biofeedback (product code HCC), Class II - Special Controls.

Submitted by Sunstar Suisse S.A. (Etoy, CH). The FDA issued a Cleared decision on September 1, 2017 after a review of 267 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 Sunstar Suisse S.A. devices

FDA 510(k) Submission Details - K163448

510(k) Number K163448 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 2016
Decision Date September 01, 2017
Days to Decision 267 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
119d slower than avg
Panel avg: 148d · This submission: 267d
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 23
Devices cleared under the same product code (HCC) and FDA review panel - the closest regulatory comparables to K163448.
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