510(k) Report

510(k) · Cleared

Cleared

5cm Tag Applicator, 7cm Tag Applicator, 10 cm Tag Applicator, 5 cm Tag Applicator (10 pack), 7cm Tag Applicator (10 pack), 10cm Tag Applicator (10 pack), LOCalizer Surgical Probe, LOCalizer Surgical Probe (5 pack)

K181692510(k) TraditionalCleared Sep 25, 201890-day reviewClass II21 CFR 878.4300

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Health Beacons, Inc. · NEU Marker, Radiographic, Implantable

Cleared on Sep 25, 2018 as substantially equivalent to K171767 (Cianna Medical, Inc., 2017) after a 90-day review. Its family tree reaches back 1 generation to 2017. 2 later devices descend from it.

Decided
Sep 25, 2018
Review
90 days
Class
Class II
Product code
NEU
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K171767 (2017). 2 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2019: 1 descendant cleared2020: 1 descendant clearedReference device: K163667 · 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. · 2017K171767 · Cianna Medical SAVI Scout Reflector and SAVI Scout System · Cianna Medical, Inc. · 2017201620182020202220242026
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 1 descendant K171767 · Cianna Medical SAVI Scout Reflector and SAVI Scout System · Cianna Medical, Inc. · 20170
  1. Root · 1 generation backK171767 Cianna Medical SAVI Scout Reflector and SAVI Scout SystemCianna Medical, Inc. · 2017
  2. This deviceK181692 5cm Tag Applicator, 7cm Tag Applicator, 10 cm Tag Applicator, 5 cm…Health Beacons, Inc. · 2018
  3. Descendant · cites it directly · 1 of its ownK190932 RFID Localization SystemHealth Beacons, Inc. · 2019
  4. Descendant · 2 generations on · 0 of its ownK193189 RFID Localization SystemHealth Beacons, Inc. · 2020

Most influential descendants

Showing 2 of 2 · See all
  • K190932RFID Localization SystemHealth Beacons, Inc. · 2019 · cites it directly1descendant
  • K193189RFID Localization SystemHealth Beacons, Inc. · 2020 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K171767Cianna Medical SAVI Scout Reflector and SAVI Scout SystemCianna Medical, Inc.2017—
0 (this device)K1816925cm Tag Applicator, 7cm Tag Applicator, 10 cm Tag Applicator, 5 cm Tag…Health Beacons, Inc.2018—
+1K190932RFID Localization SystemHealth Beacons, Inc.2019—
+2K193189RFID Localization SystemHealth Beacons, Inc.2020—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201910
202010
FIG. 1 — Lineage of K181692, 2017–2020Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in NEU? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new NEU device

  1. #1 K240042 MOLLI 2 Systemscore 14.4 · 12 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K171767Cianna Medical SAVI Scout Reflector and SAVI Scout System
Summary page 5
…RFID Localization System (RFLS) Section 7 – 510(k) Summary IV. Predicate Device • Cianna Medical SAVI Scout Reflector and SAVI Scout System o K171767 (Cianna Medical, Inc.), FDA cleared on 10/31/2017 V. Reference Devices • Health Beacons RFID Localization System - Local…
Cianna Medical, Inc.2017—
†K163667RFID Localization System- Localizer Reader, RFID Localization System- Localizer Surgical…Health Beacons, Inc.2017—
†DEN040007Implantable Radio Frequency Transponder System—
†K033440JAMM Technologies Verichip Health Information Microtransponder And Pocket Reader—

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K190932RFID Localization SystemHealth Beacons, Inc.20191

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.
  • Of its descendants, K190932 (Health Beacons, Inc., 2019) has gone furthest, with 1 descendant of its own.

How does its category compare?

All NEU devices

NEU Marker, Radiographic, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.

FDA decisions per year · NEU

5in 2025

2007: 42008: 72009: 42010: 52011: 32012: 32013: 72014: 32015: 72016: 22017: 42018: 82019: 52020: 32021: 32022: 22023: 42024: 102025: 52026 (partial year): 1
2007high 10 (2024) · low 2 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NEU

99in 2025

2007: 94 days median2008: 107 days median2009: 70 days median2010: 69 days median2011: 145 days median2012: 120 days median2013: 49 days median2014: 48 days median2015: 111 days median2017: 115 days median2018: 89 days median2019: 149 days median2020: 169 days median2021: 46 days median2023: 136 days median2024: 267 days median2025: 99 days median
2007high 267 (2024) · low 46 (2021)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · NEU

2in 2025

2011: 12017: 12022: 12024: 2, 1 Class I2025: 22026 (partial year): 2
2007high 2 (2024) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · NEU

411in 2025

2007: 52008: 52009: 302010: 122011: 182012: 542013: 602014: 382015: 1202016: 562017: 692018: 662019: 582020: 452021: 822022: 1002023: 1422024: 2472025: 411
2007high 411 (2025) · low 5 (2007)2025

MAUDE reports naming product code NEU, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200749405
2008710705
2009470030
2010569012
20113145118
20123120054
2013749060
2014348038
201571110120
20162—056
20174115169
2018889066
20195149058
20203169045
2021346082
20222—1100
202341360142
2024102672 (1)247
20255992411
20261—2—

What is it indicated for?

The Tag of the RFLS is intended for percutaneous placement in the breast to mark (>30 days) a lesion intended for surgical removal. Using image guidance (such as ultrasound or radiography) or aided by non-imaging guidance (RFLS), the RFID Tag is located and surgically removed with the target tissue. The RFLS is intended only for the non-imaging detection and localization of the Tag that has been implanted in a lesion intended for surgical removal.

Indications for use as stated in the FDA summary.

More from Health Beacons, Inc.

4 FDA decisions under this applicant name. See the company

  • K193189RFID Localization SystemHealth Beacons, Inc. · 2020
  • K190932RFID Localization SystemHealth Beacons, Inc. · 2019
  • K163667RFID Localization System- Localizer Reader, RFID Localization System- Localizer Surgical Probe, RFID…Health Beacons, Inc. · 2017

Recent decisions in NEU

The NEU category page

  • K253761HydroMARK™ Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK™ Plus Breast Biopsy Site Marker…Devicor Medical Products, Inc. · 2026
  • K253888MOLLI 2 SystemStryker Endoscopy · 20251 recall
  • K252892SCOUT MD Surgical Guidance SystemMerit Medical Systems, Inc. · 20251 recall
  • K251989VizMark Preloaded Tissue Marker Device (VM-0001)Breast-Med, Inc. · 2025
  • K251748MammoSTAR Biopsy Site IdentifierCarbon Medical Technologies, Inc. · 2025

https://510kreport.com/device/K181692 · printed Nov 6, 2026

Cite this page

510(k) Report. “K181692: 5cm Tag Applicator, 7cm Tag Applicator, 10 cm Tag Applicator, 5 cm Tag Applicator (10 pack), 7cm Tag Applicator (10 pack), 10cm Tag Applicator (10 pack), LOCalizer Surgical Probe, LOCalizer Surgical Probe (5 pack).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181692

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026