510(k) · Cleared
ClearedCianna Medical SAVI Scout Reflector and SAVI Scout System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cianna Medical, Inc. · PDW Internal Tissue Marker
Cleared on Jul 29, 2016 after a 58-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- Jul 29, 2016
- Review
- 58 days
- Class
- Class II
- Product code
- PDW
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK161507 Cianna Medical SAVI Scout Reflector and SAVI Scout SystemCianna Medical, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK163667 RFID Localization System- Localizer Reader, RFID Localization…Health Beacons, Inc. · 2017
Most influential descendants
Showing 1 of 1 · See all- K163667RFID Localization System- Localizer Reader, RFID Localization System- Localizer Surgical…Health Beacons, Inc. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K161507 | Cianna Medical SAVI Scout Reflector and SAVI Scout System | Cianna Medical, Inc. | 2016 | — |
| +1 | K163667 | RFID Localization System- Localizer Reader, RFID Localization System-… | Health Beacons, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PDW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K163667 | RFID Localization System- Localizer Reader, RFID Localization System- Localizer Surgical… | 2017 | 0 |
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?
- Of its descendants, K163667 (Health Beacons, Inc., 2017) has gone furthest, with 0 descendants of its own.
How does its category compare?
All PDW devicesPDW Internal Tissue Marker: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · PDW
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · PDW
Too few PDW 510(k)s in any year since 2007 to give a median.
Recalls per year · PDW
No recall names PDW since 2007.
Adverse event reports per year · PDW
1in 2017
MAUDE reports naming product code PDW, 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 | 0 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The SAVI Scout Reflector is intended to be placed percutaneously in the breast to temporarily mark (<30days) a lumpectomy site intended for surgical removal. Using imaging guidance (such as ultrasound or radiography) or aided by non-imaging guidance (SAVI Scout System) the SAVI Scout Reflector is located and surgically removed with the target tissue. The SAVI Scout System is intended only for the non-imaging detection and localization of the SAVI Scout Reflector that has been implanted in a lumpectomy site intended for surgical removal.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K161507 · printed Nov 5, 2026
Cite this page
510(k) Report. “K161507: Cianna Medical SAVI Scout Reflector and SAVI Scout System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K161507
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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