510(k) · Cleared

Cleared

EchoMark, EchoMark LP

K180621510(k) TraditionalCleared Jun 6, 201889-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

Sonavex, Inc. · NEU Marker, Radiographic, Implantable

Cleared on Jun 6, 2018 as substantially equivalent to K152070 (Focal Therapeutics, 2015) after an 89-day review. Its family tree reaches back 7 generations to 2001. 2 of the 15 devices in its family, counting itself, have a Class I recall.

Decided: Jun 6, 2018
Review: 89 days
Class: Class II
Product code: NEU
Recalls: None
Predicates: 1

Its longest line of descent runs back 7 generations to K001807 (2001). 14 ancestors in all. No later device cites it as a predicate yet. 2 of the 15 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 7 generations backK001807 Tissue MarkerAdvanced Uroscience, Inc. · 2001
6 generations backK032347 Biomarc Tissue MarkerCarbon Medical Technologies, Inc. · 2003
5 generations backK042296 Biomarc Preloaded Tissue Marker DeviceCarbon Medical Technologies, Inc. · 2004
4 generations backK072913 Securmark Biopsy Site Identification SystemSuros Surgical Systems, Inc. A Hologic Company · 2008
3 generations backK113202 Tissue MarkerFocal Therapeutics · 2012
2 generations backK143484 BioZorb MarkerFocal Therapeutics · 2015 · Recalled (Class I)
1 generation backK152070 BioZorb LP MarkerFocal Therapeutics · 2015 · Recalled (Class I)
This deviceK180621 EchoMark, EchoMark LPSonavex, Inc. · 2018

Class I recalls in this family

K152070 BioZorb LP Markerdirect predicate · 2015
K143484 BioZorb Marker2 generations back · 2015

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−7	K001807	Tissue Marker	Advanced Uroscience, Inc.	2001	—
−6	K032347	Biomarc Tissue Marker	Carbon Medical Technologies, Inc.	2003	—
−5	K042296	Biomarc Preloaded Tissue Marker Device	Carbon Medical Technologies, Inc.	2004	—
−4	K072913	Securmark Biopsy Site Identification System	Suros Surgical Systems, Inc. A Hologic Company	2008	—
−3	K113202	Tissue Marker	Focal Therapeutics	2012	—
−2	K143484	BioZorb Marker	Focal Therapeutics	2015	Class I
−1	K152070	BioZorb LP Marker	Focal Therapeutics	2015	Class I
0 (this device)	K180621	EchoMark, EchoMark LP	Sonavex, Inc.	2018	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2002	1	0
2003	1	0
2007	2	0
2010	1	0
2011	1	0

FIG. 1 — Lineage of K180621, 2001–2018Source: 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.

2 devices in this family have a Class I recall. 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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K152070	BioZorb LP Marker Summary page 4 …diographic Marker Classification Name: Implantable Clip, 21 CFR 878.4300 Device Classification: Class II Product Code: NEU Predicate Device: K152070, BioZorb LP Marker Reference Device: K112267, Polyganics Neurolac Nerve Guide Substantially Equivalent to: The EchoMark…	Focal Therapeutics	2015	Class I
†	K112267	Neurolac (R) Nerve Guide	Polyganics B.V.,	2011	—

Also cleared against K152070: 3 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (2 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K152070BioZorb LP MarkerFocal Therapeutics · 2015 · Direct predicate · ◆ on the line of descent in FIG. 12 Class I recalls
K143484BioZorb MarkerFocal Therapeutics · 2015 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 17 years and passes through 5 companies; a new generation was cleared every 2.8 years on median.
3 of the 14 ancestors have a recall of any class; 2 have a Class I recall.
3 other devices also cite its predicate K152070.

How does its category compare?

All NEU devices

NEU 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

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 EchoMark and EchoMark LP are indicated for radiographic marking of sites in soft tissue.

In addition, the EchoMark and EchoMark LP are indicated for situations where a soft tissue site needs to be marked for future medical procedures.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K180621 · printed Nov 5, 2026

Cite this page

510(k) Report. “K180621: EchoMark, EchoMark LP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K180621

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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