510(k) · Cleared
ClearedRFID 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)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Health Beacons, Inc. · PBY Temporary Tissue Marker
Cleared on Apr 28, 2017 as substantially equivalent to K161507 (Cianna Medical, Inc., 2016) after a 122-day review. Its family tree reaches back 1 generation to 2016.
- Decided
- Apr 28, 2017
- Review
- 122 days
- Class
- Class II
- Product code
- PBY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K161507 (2016). No later device cites it as a predicate yet.
- Root · 1 generation backK161507 Cianna Medical SAVI Scout Reflector and SAVI Scout SystemCianna Medical, Inc. · 2016
- This deviceK163667 RFID Localization System- Localizer Reader, RFID Localization…Health Beacons, Inc. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K161507 | Cianna Medical SAVI Scout Reflector and SAVI Scout System | Cianna Medical, Inc. | 2016 | — |
| 0 (this device) | K163667 | RFID Localization System- Localizer Reader, RFID Localization System-… | Health Beacons, Inc. | 2017 | — |
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 PBY? 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 PBY device
- #1 K222643 Sirius Pintuition Seed, Sirius Pintuition…score 9.9 · 10 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 |
|---|---|---|---|
| * | K161507 | Cianna Medical SAVI Scout Reflector and SAVI Scout SystemSummary page 5…RFID Localization System (RFLS) III. PREDICATE Cianna Medical, Inc. SAVI Scout Reflector and SAVI Scout System (K161507) IV. DEVICE DESCRIPTION The RFID Localization System (RFLS) is a marker-with-detector localization device… | 2016 |
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?
- Its one ancestor has no recall.
How does its category compare?
All PBY devicesPBY Temporary Tissue Marker: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · PBY
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · PBY
Too few PBY 510(k)s in any year since 2007 to give a median.
Recalls per year · PBY
No recall names PBY since 2007.
Adverse event reports per year · PBY
1in 2024
MAUDE reports naming product code PBY, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 2 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Tag of the RFLS is intended for percutaneous placement in the breast to temporarily (<30 days) mark 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.
https://510kreport.com/device/K163667 · printed Nov 6, 2026
Cite this page
510(k) Report. “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).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163667
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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