510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K163667Substantially Equivalent

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)

Health Beacons, Inc., Concord MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K163667 is the FDA 510(k) clearance record for 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), a class II device, cleared for Health Beacons, Inc. on under FDA product code PBY (Temporary Tissue Marker). FDA's definition for product code PBY reads: "To temporarily (< 30 days) mark a tissue site intended for surgical removal. The tissue marker is surgically removed with the target tissue". FDA records list 4 510(k) clearances for Health Beacons, Inc., from to . As of , FDA records show no recalls naming K163667.

Clearance record

Decision date
Received
(122 days to decision)
Product code
PBY Temporary Tissue Marker
Regulation
21 CFR 878.4300
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Health Beacons, Inc. 34 Walden St. #753, Concord MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PBY

Trailing 12 months

FDA records hold no clearances under product code PBY in the trailing twelve months.

FDA records show no clearances under product code PBY in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PBY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260