510(k) Report

510(k) · Cleared

Cleared

Micromark II Tissue Marker,Model C1535

K013413510(k) TraditionalCleared Dec 3, 200149-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

Ethicon Endo-Surgery, Inc. · NEU Marker, Radiographic, Implantable

Cleared on Dec 3, 2001 after a 49-day review. The FDA summary names its predicate without a number. 26 later devices descend from it.

Decided
Dec 3, 2001
Review
49 days
Class
Class II
Product code
NEU
Recalls
None
Predicates
0

26 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2004: 1 descendant cleared2008: 1 descendant cleared2010: 1 descendant cleared2007: 1 descendant cleared2021: 3 descendants cleared2011: 1 descendant cleared2024: 3 descendants cleared2018: 4 descendants cleared2012: 1 descendant cleared2013: 2 descendants cleared2016: 1 descendant cleared2023: 4 descendants cleared2017: 1 descendant cleared2022: 1 descendant cleared2025: 1 descendant cleared200020052010201520202025
  1. This deviceK013413 Micromark II Tissue Marker,Model C1535Ethicon Endo-Surgery, Inc. · 2001
  2. Descendant · cites it directly · 25 of its ownK033447 Cliploc Soft Tissue Marker 18G/100MM (4), /130MM (5 1/8), /150MM…Mri Devices Corp. · 2004
  3. Descendant · 2 generations on · 23 of its ownK073095 Tumark Professional, Model 271560; MR- Tumark Professional, Model…Somatex Medical Technologies GmbH · 2008 · Recalled
  4. Descendant · 2 generations on · 21 of its ownK093064 Tumark Professional, Model 271560, MR-Tumark Professional, Model…Somatex Medical Technologies GmbH · 2010
  5. Descendant · 3 generations on · 16 of its ownK111692 Tumark Flex for Mammotome,Tumark Flex for AtecSomatex Medical Technologies GmbH · 2011
  6. Descendant · 4 generations on · 15 of its ownK120804 Cianna Medical Tissue Marker and Delivery SystemCianna Medical · 2013

Showing 5 of 26 descendants. See all descendants

Descendants cleared per year

2004: 12007: 12008: 12010: 12011: 12012: 12013: 22016: 12017: 12018: 42021: 32022: 12023: 42024: 32025: 1
2004high 4 (2018) · low 0 (2005)2026

Most influential descendants

Showing 5 of 26 · See all
  • K033447Cliploc Soft Tissue Marker 18G/100MM (4), /130MM (5 1/8), /150MM (6), Models 12370…Mri Devices Corp. · 2004 · cites it directly25descendants
  • K073095Tumark Professional, Model 271560; MR- Tumark Professional, Model 601560Somatex Medical Technologies GmbH · 2008 · 2 generations on23descendants
  • K093064Tumark Professional, Model 271560, MR-Tumark Professional, Model 601560Somatex Medical Technologies GmbH · 2010 · 2 generations on21descendants
  • K111692Tumark Flex for Mammotome,Tumark Flex for AtecSomatex Medical Technologies GmbH · 2011 · 3 generations on16descendants
  • K120804Cianna Medical Tissue Marker and Delivery SystemCianna Medical · 2013 · 4 generations on15descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K013413Micromark II Tissue Marker,Model C1535Ethicon Endo-Surgery, Inc.2001—
+1K033447Cliploc Soft Tissue Marker 18G/100MM (4), /130MM (5 1/8), /150MM (6), Models…Mri Devices Corp.2004—
+2K073095Tumark Professional, Model 271560; MR- Tumark Professional, Model 601560Somatex Medical Technologies GmbH20081
+2K093064Tumark Professional, Model 271560, MR-Tumark Professional, Model 601560Somatex Medical Technologies GmbH2010—
+3K111692Tumark Flex for Mammotome,Tumark Flex for AtecSomatex Medical Technologies GmbH2011—
+4K120804Cianna Medical Tissue Marker and Delivery SystemCianna Medical2013—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200710
200810
201010
201110
201210
201320
201610
201710
201840
202130
202210
202340
202430
202510
FIG. 1 — Lineage of K013413, 2001–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K240042 MOLLI 2 Systemscore 14.4 · 12 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #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.

TypeNumberDeviceApplicantDecidedRecalls
*—MicroMark™ Clip
Named without a submission number
—

What descends from it? (26)

See all 26

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

NumberDeviceApplicantDecidedDescendants
K033447Cliploc Soft Tissue Marker 18G/100MM (4), /130MM (5 1/8), /150MM (6), Models 12370…Mri Devices Corp.200425

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, K033447 (Mri Devices Corp., 2004) has gone furthest, with 25 descendants of its own.

How does its category compare?

All NEU devices

NEU Marker, Radiographic, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NEU

5in 2025

2007: 42008: 72009: 42010: 52011: 32012: 32013: 72014: 32015: 72016: 22017: 42018: 82019: 52020: 32021: 32022: 22023: 42024: 102025: 52026 (partial year): 1
2007high 10 (2024) · low 2 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NEU

99in 2025

2007: 94 days median2008: 107 days median2009: 70 days median2010: 69 days median2011: 145 days median2012: 120 days median2013: 49 days median2014: 48 days median2015: 111 days median2017: 115 days median2018: 89 days median2019: 149 days median2020: 169 days median2021: 46 days median2023: 136 days median2024: 267 days median2025: 99 days median
2007high 267 (2024) · low 46 (2021)2026

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

Recalls per year · NEU

2in 2025

2011: 12017: 12022: 12024: 2, 1 Class I2025: 22026 (partial year): 2
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

2007: 52008: 52009: 302010: 122011: 182012: 542013: 602014: 382015: 1202016: 562017: 692018: 662019: 582020: 452021: 822022: 1002023: 1422024: 2472025: 411
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200749405
2008710705
2009470030
2010569012
20113145118
20123120054
2013749060
2014348038
201571110120
20162—056
20174115169
2018889066
20195149058
20203169045
2021346082
20222—1100
202341360142
2024102672 (1)247
20255992411
20261—2—

What is it indicated for?

The MicroMark™ II Tissue Marker is indicated for use to attach to soft breast tissue at the surgical site during an open surgical breast biopsy or a percutaneous breast biopsy to radiographically mark the location of the biopsy procedure.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Ethicon Endo-Surgery, Inc.

111 FDA decisions under this applicant name. See the company

  • K141952Echelon Flex Powered Vascular Stapler with Advanced Placement Tip, Endopath Echelon Vascular White Reloads…Ethicon Endo-Surgery, Inc. · 20141 Class I recall
  • K111195Valutrus Reusable Circular Stapler and Disposable ReloadsEthicon Endo-Surgery, Inc. · 2011
  • K110385Echelon Flex 45 / 60 Powered Articulating Endoscopic Linear CutterEthicon Endo-Surgery, Inc. · 2011
  • K101520Enseal Tissue Sealing Devices Model: NSEAL514H-535H, NSEAL514RH-535RHEthicon Endo-Surgery, Inc. · 2010
  • K102632Ethicon Endo-Surgery 5MM Laparoscopic Multi-Feed StaplerEthicon Endo-Surgery, Inc. · 2010

Recent decisions in NEU

The NEU category page

  • K253761HydroMARK™ Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK™ Plus Breast Biopsy Site Marker…Devicor Medical Products, Inc. · 2026
  • K253888MOLLI 2 SystemStryker Endoscopy · 20251 recall
  • K252892SCOUT MD Surgical Guidance SystemMerit Medical Systems, Inc. · 20251 recall
  • K251989VizMark Preloaded Tissue Marker Device (VM-0001)Breast-Med, Inc. · 2025
  • K251748MammoSTAR Biopsy Site IdentifierCarbon Medical Technologies, Inc. · 2025

https://510kreport.com/device/K013413 · printed Nov 5, 2026

Cite this page

510(k) Report. “K013413: Micromark II Tissue Marker,Model C1535.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K013413

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026