Cleared Traditional

RFID Localization System- Localizer Reader, RFID Localization System- Localizer Surgical Probe, RFID Localization System- Localizer Surgical Probe (5 pack), RFID Localization System- Tag Applicator, RFID Localization System -Tag Applicator (10 pack) (K163667) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K163667 · Health Beacons, Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Apr 2017
Decision
122d
Days
Class 2
Risk

K163667 is an FDA 510(k) clearance for the RFID Localization System- Localizer Reader, RFID Localization System- Localiz.... Classified as Temporary Tissue Marker (product code PBY), Class II - Special Controls.

Submitted by Health Beacons, Inc. (Concord, US). The FDA issued a Cleared decision on April 28, 2017 after a review of 122 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4300 - the FDA general and plastic surgery 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 General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Health Beacons, Inc. devices

Submission Details

510(k) Number K163667 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 2016
Decision Date April 28, 2017
Days to Decision 122 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d slower than avg
Panel avg: 115d · This submission: 122d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PBY Temporary Tissue Marker
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4300
Definition To Temporarily (< 30 Days) Mark A Tissue Site Intended For Surgical Removal. The Tissue Marker Is Surgically Removed With The Target Tissue.
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - PBY Temporary Tissue Marker

Devices cleared under the same product code (PBY) and FDA review panel - the closest regulatory comparables to K163667.
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