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. · NEU Marker, Radiographic, Implantable
Cleared on Aug 2, 2018 after a 107-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 11 later devices descend from it.
- Decided
- Aug 2, 2018
- Review
- 107 days
- Class
- Class II
- Product code
- NEU
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 5 citing it directly.
- This deviceK181007 Cianna Medical SAVI Scout Reflector and SAVI Scout SystemCianna Medical, Inc. · 2018
- Descendant · cites it directly · 5 of its ownK210600 MOLLIMolli Surgical, Inc. · 2021
- Descendant · 2 generations on · 4 of its ownK223107 MOLLI 2Molli Surgical, Inc. · 2023
- Descendant · 3 generations on · 3 of its ownK231579 MOLLI 2Molli Surgical, Inc. · 2023 · Recalled
- Descendant · 4 generations on · 1 of its ownK240042 MOLLI 2 SystemMolli Surgical, Inc. · 2024
- Descendant · cites it directly · 1 of its ownK231468 SCOUT MD Surgical Guidance SystemMerit Medical System, Inc. · 2024
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K210600MOLLIMolli Surgical, Inc. · 2021 · cites it directly5descendants
- K223107MOLLI 2Molli Surgical, Inc. · 2023 · 2 generations on4descendants
- K231579MOLLI 2Molli Surgical, Inc. · 2023 · 3 generations on3descendants
- K240042MOLLI 2 SystemMolli Surgical, Inc. · 2024 · 4 generations on1descendant
- K231468SCOUT MD Surgical Guidance SystemMerit Medical System, Inc. · 2024 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K181007 | Cianna Medical SAVI Scout Reflector and SAVI Scout System | Cianna Medical, Inc. | 2018 | — |
| +1 | K210600 | MOLLI | Molli Surgical, Inc. | 2021 | — |
| +2 | K223107 | MOLLI 2 | Molli Surgical, Inc. | 2023 | — |
| +3 | K231579 | MOLLI 2 | Molli Surgical, Inc. | 2023 | 1 |
| +4 | K240042 | MOLLI 2 System | Molli Surgical, Inc. | 2024 | — |
| +1 | K231468 | SCOUT MD Surgical Guidance System | Merit Medical System, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 4 | 0 |
| 2025 | 2 | 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 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (11)
See all 115 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K210600 (Molli Surgical, Inc., 2021) has gone furthest, with 5 descendants of its own.
How does its category compare?
All NEU devicesNEU 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
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 SAVI Scout Reflector is intended to be placed percutaneously in soft tissue to mark (>30 days) a biopsy site or a soft tissue site intended for surgical removal. Using imaging guidance (such as ultrasound, MRI, 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 soft tissue biopsy site or a soft tissue site intended for surgical removal.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K181007 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181007: 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 6, 2026. https://510kreport.com/device/K181007
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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