510(k) · Cleared

Cleared

SCOUT MD Surgical Guidance System

K231468510(k) TraditionalCleared Feb 12, 2024266-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

Merit Medical System, Inc. · NEU Marker, Radiographic, Implantable

Cleared on Feb 12, 2024 as substantially equivalent to K181007 (Cianna Medical, Inc., 2018) after a 266-day review. Its family tree reaches back 1 generation to 2018. 1 later device descends from it.

Decided: Feb 12, 2024
Review: 266 days
Class: Class II
Product code: NEU
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K181007 (2018). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK181007 Cianna Medical SAVI Scout Reflector and SAVI Scout SystemCianna Medical, Inc. · 2018
This deviceK231468 SCOUT MD Surgical Guidance SystemMerit Medical System, Inc. · 2024
Descendant · cites it directly · 0 of its ownK252892 SCOUT MD Surgical Guidance SystemMerit Medical Systems, Inc. · 2025 · Recalled

Most influential descendants

Showing 1 of 1 · See all

K252892SCOUT MD Surgical Guidance SystemMerit Medical Systems, Inc. · 2025 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K181007	Cianna Medical SAVI Scout Reflector and SAVI Scout System	Cianna Medical, Inc.	2018	—
0 (this device)	K231468	SCOUT MD Surgical Guidance System	Merit Medical System, Inc.	2024	—
+1	K252892	SCOUT MD Surgical Guidance System	Merit Medical Systems, Inc.	2025	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2025	1	0

FIG. 1 — Lineage of K231468, 2018–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K181007	Cianna Medical SAVI Scout Reflector and SAVI Scout System Summary page 4 …SAVI Scout Reflector and SAVI Scout System Classification Name: Marker, Radiographic, Implantable Predicate Device Premarket Notification: K181007 Manufacturer: Merit Medical Systems, Inc. Predicate has not been a subject of a d…	Cianna Medical, Inc.	2018	—

Also cleared against K181007: 4 other devices →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K252892	SCOUT MD Surgical Guidance System	Merit Medical Systems, Inc.	2025	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?

Its one ancestor has no recall.
Of its descendants, K252892 (Merit Medical Systems, Inc., 2025) has gone furthest, with 0 descendants of its own.
4 other devices also cite its predicate K181007.

How does its category compare?

All NEU devices

NEU Marker, Radiographic, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.

FDA decisions per year · NEU

5in 2025

2007high 10 (2024) · low 2 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NEU

99in 2025

2007high 267 (2024) · low 46 (2021)2026

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

Recalls per year · NEU

2in 2025

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

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

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 SCOUT MD Reflector is intended to be placed percutaneously in soft tissue (>30 days) to mark 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 (SCOUT MD System) the SCOUT MD Reflector is located and surgically removed with the target tissue. The SCOUT MD System is intended only for the non-imaging detection and localization of the SCOUT MD 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 summary.

https://510kreport.com/device/K231468 · printed Nov 6, 2026

Cite this page

510(k) Report. “K231468: SCOUT MD Surgical Guidance System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231468

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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