510(k) · Cleared
ClearedRFID Localization System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Health Beacons, Inc. · NEU Marker, Radiographic, Implantable
Cleared on May 6, 2020 as substantially equivalent to K190932 (Health Beacons, Inc., 2019) after a 169-day review. Its family tree reaches back 3 generations to 2017.
- Decided
- May 6, 2020
- Review
- 169 days
- Class
- Class II
- Product code
- NEU
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K171767 (2017). No later device cites it as a predicate yet.
- Root · 3 generations backK171767 Cianna Medical SAVI Scout Reflector and SAVI Scout SystemCianna Medical, Inc. · 2017
- 2 generations backK181692 5cm Tag Applicator, 7cm Tag Applicator, 10 cm Tag Applicator, 5 cm…Health Beacons, Inc. · 2018
- 1 generation backK190932 RFID Localization SystemHealth Beacons, Inc. · 2019
- This deviceK193189 RFID Localization SystemHealth Beacons, Inc. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K171767 | Cianna Medical SAVI Scout Reflector and SAVI Scout System | Cianna Medical, Inc. | 2017 | — |
| −2 | K181692 | 5cm Tag Applicator, 7cm Tag Applicator, 10 cm Tag Applicator, 5 cm Tag… | Health Beacons, Inc. | 2018 | — |
| −1 | K190932 | RFID Localization System | Health Beacons, Inc. | 2019 | — |
| 0 (this device) | K193189 | RFID Localization System | Health Beacons, Inc. | 2020 | — |
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 K240042 MOLLI 2 Systemscore 14.4 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K190932 | RFID Localization SystemSummary page 5…Page 2 of 7 IV. Predicate Device • Health Beacons RFID Localization System o K190932 (Health Beacons Inc.), FDA cleared on 09/13/2019 V. Reference Devices • JAMM Technologies Verichip Health Information… | 2019 |
| † | DEN040007 | Implantable Radio Frequency Transponder System | |
| † | K033440 | JAMM Technologies Verichip Health Information Microtransponder And Pocket Reader | |
| † | K181007 | Cianna Medical SAVI Scout Reflector and SAVI Scout System | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 3 years and passes through 2 companies; a new generation was cleared every 11 months on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All NEU devicesNEU Marker, Radiographic, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · NEU
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NEU
99in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NEU
2in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · NEU
411in 2025
MAUDE reports naming product code NEU, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 4 | 94 | 0 | 5 |
| 2008 | 7 | 107 | 0 | 5 |
| 2009 | 4 | 70 | 0 | 30 |
| 2010 | 5 | 69 | 0 | 12 |
| 2011 | 3 | 145 | 1 | 18 |
| 2012 | 3 | 120 | 0 | 54 |
| 2013 | 7 | 49 | 0 | 60 |
| 2014 | 3 | 48 | 0 | 38 |
| 2015 | 7 | 111 | 0 | 120 |
| 2016 | 2 | — | 0 | 56 |
| 2017 | 4 | 115 | 1 | 69 |
| 2018 | 8 | 89 | 0 | 66 |
| 2019 | 5 | 149 | 0 | 58 |
| 2020 | 3 | 169 | 0 | 45 |
| 2021 | 3 | 46 | 0 | 82 |
| 2022 | 2 | — | 1 | 100 |
| 2023 | 4 | 136 | 0 | 142 |
| 2024 | 10 | 267 | 2 (1) | 247 |
| 2025 | 5 | 99 | 2 | 411 |
| 2026 | 1 | — | 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K193189 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193189: RFID Localization System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193189
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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