510(k) · Cleared

Cleared

Biomarc Tissue Marker

K032347510(k) SpecialCleared Aug 21, 200322-day reviewClass II21 CFR 878.4750

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Carbon Medical Technologies, Inc. · GDW Staple, Implantable

Cleared on Aug 21, 2003 as substantially equivalent to K001807 (Advanced Uroscience, Inc., 2001) after a 22-day review. Its family tree reaches back 1 generation to 2001. 2 of the 47 devices in its family, counting itself, have a Class I recall. 45 later devices descend from it.

Decided: Aug 21, 2003
Review: 22 days
Class: Class II
Product code: GDW
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K001807 (2001). 45 later devices descend from it, 2 citing it directly. 2 of the 47 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 1 generation backK001807 Tissue MarkerAdvanced Uroscience, Inc. · 2001
This deviceK032347 Biomarc Tissue MarkerCarbon Medical Technologies, Inc. · 2003
Descendant · cites it directly · 44 of its ownK042296 Biomarc Preloaded Tissue Marker DeviceCarbon Medical Technologies, Inc. · 2004
Descendant · 2 generations on · 25 of its ownK063193 Modification to Biomarc Tissue MarkerCarbon Medical Technologies, Inc. · 2006
Descendant · 3 generations on · 17 of its ownK070436 Biomarc Gold Tissue MarkerCarbon Medical Technologies, Inc. · 2007
Descendant · 2 generations on · 10 of its ownK111895 Echotip (R) Ultra Fiducial NeedleWilson-Cook Medical Inc./Cook Endoscopy · 2012
Descendant · 2 generations on · 10 of its ownK072913 Securmark Biopsy Site Identification SystemSuros Surgical Systems, Inc. A Hologic Company · 2008

Showing 5 of 45 descendants. See all descendants

Descendants cleared per year

2004high 7 (2015) · low 0 (2005)2026

Class I recalls in this family

K143484 BioZorb Marker4 generations on · 2015
K152070 BioZorb LP Marker5 generations on · 2015

Most influential descendants

Showing 5 of 45 · See all

K042296Biomarc Preloaded Tissue Marker DeviceCarbon Medical Technologies, Inc. · 2004 · cites it directly44descendants
K063193Modification to Biomarc Tissue MarkerCarbon Medical Technologies, Inc. · 2006 · 2 generations on25descendants
K070436Biomarc Gold Tissue MarkerCarbon Medical Technologies, Inc. · 2007 · 3 generations on17descendants
K111895Echotip (R) Ultra Fiducial NeedleWilson-Cook Medical Inc./Cook Endoscopy · 2012 · 2 generations on10descendants
K072913Securmark Biopsy Site Identification SystemSuros Surgical Systems, Inc. A Hologic Company · 2008 · 2 generations on10descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K001807	Tissue Marker	Advanced Uroscience, Inc.	2001	—
0 (this device)	K032347	Biomarc Tissue Marker	Carbon Medical Technologies, Inc.	2003	—
+1	K042296	Biomarc Preloaded Tissue Marker Device	Carbon Medical Technologies, Inc.	2004	—
+2	K063193	Modification to Biomarc Tissue Marker	Carbon Medical Technologies, Inc.	2006	—
+3	K070436	Biomarc Gold Tissue Marker	Carbon Medical Technologies, Inc.	2007	—
+2	K111895	Echotip (R) Ultra Fiducial Needle	Wilson-Cook Medical Inc./Cook Endoscopy	2012	—
+2	K072913	Securmark Biopsy Site Identification System	Suros Surgical Systems, Inc. A Hologic Company	2008	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2006	1	0
2007	1	0
2008	1	0
2010	3	0
2011	1	0
2012	2	0
2013	4	0
2014	4	0
2015	7	2
2017	5	0
2018	5	0
2019	2	0
2020	1	0
2021	1	0
2023	1	0
2024	3	0
2025	2	0

FIG. 1 — Lineage of K032347, 2001–2025Source: 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.

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 GDW device

#1 K253657 Tri-staple 2.0™ Reloads; Endo GIA™ Reloads…score 15.0 · 14 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
*	K001807	Tissue Marker	Advanced Uroscience, Inc.	2001	—

Also cleared against K001807: 2 other devices →

What descends from it? (45)

See all 45

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K042296	Biomarc Preloaded Tissue Marker Device	Carbon Medical Technologies, Inc.	2004	44
K133697	Breast-Med Tissue Marker	Breast-Med, Inc.	2015	1

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 · 4 generations on · ◆ in the 2015 descendants bar of FIG. 11 Class I recall
K152070BioZorb LP MarkerFocal Therapeutics · 2015 · 5 generations on · ◆ in the 2015 descendants bar of FIG. 12 Class I recalls

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K042296 (Carbon Medical Technologies, Inc., 2004) has gone furthest, with 44 descendants of its own.
2 other devices also cite its predicate K001807.

How does its category compare?

All GDW devices

GDW Staple, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GDW

3in 2025

2007high 15 (2014) · low 2 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GDW

111in 2025

2007high 267 (2023) · low 27 (2009)2026

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

Recalls per year · GDW

3in 2025

2007high 22 (2009) · low 0 (2008)2026

Class I (5 since 2007) Class II/III not classified

Adverse event reports per year · GDW

11,905in 2025

2007high 16,600 (2019) · low 2,380 (2008)2025

MAUDE reports naming product code GDW, 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	8	56	9	2,401
2008	7	57	0	2,380
2009	13	27	22	4,014
2010	10	39	2	3,768
2011	11	49	9	3,826
2012	9	45	11 (1)	3,717
2013	13	49	1	3,777
2014	15	63	0	4,784
2015	8	111	6	4,899
2016	11	96	2	5,106
2017	13	103	3	11,643
2018	7	90	3	14,914
2019	12	205	4 (4)	16,600
2020	10	88	11	12,332
2021	9	233	0	13,015
2022	7	89	0	13,605
2023	4	267	1	14,623
2024	2	—	0	13,280
2025	3	111	3	11,905
2026	3	141	0	—

What is it indicated for?

The BiomarC Tissue Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K032347 · printed Nov 5, 2026

Cite this page

510(k) Report. “K032347: Biomarc Tissue Marker.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K032347

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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