510(k) · Cleared

Cleared

Tissue Marker

K113202510(k) TraditionalCleared Feb 28, 2012120-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

Focal Therapeutics · NEU Marker, Radiographic, Implantable

Cleared on Feb 28, 2012 as substantially equivalent to K062528 (Suros Surgical Systems, Inc., 2007) and 3 other predicates after a 120-day review. Its family tree reaches back 4 generations to 2001. 2 of the 17 devices in its family, counting itself, have a Class I recall. 8 later devices descend from it.

Decided: Feb 28, 2012
Review: 120 days
Class: Class II
Product code: NEU
Recalls: None
Predicates: 4

Its longest line of descent runs back 4 generations to K001807 (2001). 8 ancestors in all. 8 later devices descend from it, 1 citing it directly. 2 of the 17 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 4 generations backK001807 Tissue MarkerAdvanced Uroscience, Inc. · 2001
3 generations backK032347 Biomarc Tissue MarkerCarbon Medical Technologies, Inc. · 2003
2 generations backK042296 Biomarc Preloaded Tissue Marker DeviceCarbon Medical Technologies, Inc. · 2004
1 generation backK072913 Securmark Biopsy Site Identification SystemSuros Surgical Systems, Inc. A Hologic Company · 2008
This deviceK113202 Tissue MarkerFocal Therapeutics · 2012
Descendant · cites it directly · 7 of its ownK143484 BioZorb MarkerFocal Therapeutics · 2015 · Recalled (Class I)
Descendant · 2 generations on · 5 of its ownK152070 BioZorb LP MarkerFocal Therapeutics · 2015 · Recalled (Class I)
Descendant · 2 generations on · 1 of its ownK180640 SmartClip Soft Tissue MarkerElucent Medical, Inc. · 2018
Descendant · 3 generations on · 0 of its ownK233639 SmartClip Secure Soft Tissue MarkerElucent Medical, Inc. · 2024
Descendant · 2 generations on · 0 of its ownK192371 BioZorb SP MarkerFocal Therapeutics · 2019

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2015high 3 (2018) · low 0 (2016)2026

Class I recalls in this family

K143484 BioZorb Markercites it directly · 2015
K152070 BioZorb LP Marker2 generations on · 2015

Most influential descendants

Showing 5 of 8 · See all

K143484BioZorb MarkerFocal Therapeutics · 2015 · cites it directly7descendants
K152070BioZorb LP MarkerFocal Therapeutics · 2015 · 2 generations on5descendants
K180640SmartClip Soft Tissue MarkerElucent Medical, Inc. · 2018 · 2 generations on1descendant
K233639SmartClip Secure Soft Tissue MarkerElucent Medical, Inc. · 2024 · 3 generations on0descendants
K192371BioZorb SP MarkerFocal Therapeutics · 2019 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K001807	Tissue Marker	Advanced Uroscience, Inc.	2001	—
−3	K032347	Biomarc Tissue Marker	Carbon Medical Technologies, Inc.	2003	—
−2	K042296	Biomarc Preloaded Tissue Marker Device	Carbon Medical Technologies, Inc.	2004	—
−1	K072913	Securmark Biopsy Site Identification System	Suros Surgical Systems, Inc. A Hologic Company	2008	—
0 (this device)	K113202	Tissue Marker	Focal Therapeutics	2012	—
+1	K143484	BioZorb Marker	Focal Therapeutics	2015	Class I
+2	K152070	BioZorb LP Marker	Focal Therapeutics	2015	Class I
+2	K180640	SmartClip Soft Tissue Marker	Elucent Medical, Inc.	2018	—
+3	K233639	SmartClip Secure Soft Tissue Marker	Elucent Medical, Inc.	2024	—
+2	K192371	BioZorb SP Marker	Focal Therapeutics	2019	—

Other ancestors by year cleared

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

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2015	2	2
2017	1	0
2018	3	0
2019	1	0
2024	1	0

FIG. 1 — Lineage of K113202, 2001–2024Source: 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? (4)

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
*	K062528	Tissue Site Marking System Summary page 1 …Class 11 CLASSIFICATION: PRODUCT CODE: NEU PREDICATE DEVICES: H-ologic/Suros Tissue Site Marking System (K062528, K072913); Bard/SenoRx GelMark Ultra (KOI 11402); Devicor/Artemis CorMARK M…	Suros Surgical Systems, Inc.	2007	—
*	K072913	Securmark Biopsy Site Identification System Summary page 1 …Class 11 CLASSIFICATION: PRODUCT CODE: NEU PREDICATE DEVICES: H-ologic/Suros Tissue Site Marking System (K062528, K072913); Bard/SenoRx GelMark Ultra (KOI 11402); Devicor/Artemis CorMARK Marker (K0…	Suros Surgical Systems, Inc. A Hologic Company	2008	—
*	K011402	Biopsy Site Marker	Senorx, Inc.	2001	—
*	K032217	14G Cormark Biopsy Site Identifier Summary page 1 …(K062528, K072913); Bard/SenoRx GelMark Ultra (KOI 11402); Devicor/Artemis CorMARK Marker (K0322 17) Substantially Equivalent To: The Focal Therapeutics BioZorbM Tissue Marker is substantially equivalent in intended use, princip…	Artemis Medical, Inc.	2003	—

Also cleared against K062528: 3 other devices →

What descends from it? (8)

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

Number	Device	Applicant	Decided	Descendants
K143484	BioZorb Marker Class I	Focal Therapeutics	2015	7

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.

K143484BioZorb MarkerFocal Therapeutics · 2015 · Cites it directly · ◆ in the 2015 descendants bar of FIG. 11 Class I recall
K152070BioZorb LP MarkerFocal Therapeutics · 2015 · 2 generations on · ◆ in the 2015 descendants bar of FIG. 12 Class I recalls

What does this lineage say?

The line of descent spans 11 years and passes through 4 companies; a new generation was cleared every 3.3 years on median.
None of the 8 ancestors has a recall.
Of its descendants, K143484 (Focal Therapeutics, 2015) has gone furthest, with 7 descendants of its own.
3 other devices also cite its predicate K062528.

How does its category compare?

All NEU devices

NEU Marker, Radiographic, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 BioZorb T' Tissue Marker is indicated for radiographic marking of sites in soft tissue.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K113202 · printed Nov 6, 2026

Cite this page

510(k) Report. “K113202: Tissue Marker.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113202

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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