510(k) Report

510(k) · Cleared

Cleared

Biopsy Sciences LLC Hydromark Breast Biopsy Site Marker

K130537510(k) SpecialCleared Mar 29, 201328-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

Biopsy Sciences, LLC · NEU Marker, Radiographic, Implantable

Cleared on Mar 29, 2013 as substantially equivalent to K060769 (Biopsy Sciences, LLC, 2006) and 3 other predicates after a 28-day review. Its family tree reaches back 7 generations to 2003. 3 later devices descend from it.

Decided
Mar 29, 2013
Review
28 days
Class
Class II
Product code
NEU
Recalls
None
Predicates
4

Its longest line of descent runs back 7 generations to K023694 (2003). 9 ancestors in all, the oldest K970817 (1997). 3 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2004: 1 other ancestor1997: 1 other ancestor2016: 1 descendant cleared2017: 1 descendant cleared2020: 1 descendant clearedK023694 · Bio-Mark Resorbable Biopsy Site Marker and Bio-Mark Permanent Biopsy Site Marker · Biopsy Sciences, LLC · 2003K051421 · Inter V Brand V-Mark Breast Biopsy Site Marker with Titanium Anchor · Medical Device Technologies, Inc. · 2005K053518 · Interv Brand V-Mark Breast Biopsy Site Marker with Titanium Anchor · Medical Device Technologies, Inc. · 2006K060769 · Hydromark Biopsy Site Marker · Biopsy Sciences, LLC · 2006×2: 2 generations cleared close together, K083006 (2009), K090501 (2009) K121113 · Biopsy Sciences, Inc. Hydromark Brest Biosy Site Marker · Biopsy Sciences, LLC · 20121995200020052010201520202025
Other ancestors, by generationDescendants, by generation 2 generations back: 2 other ancestors 1 generation forward: 1 descendant2 generations forward: 2 descendants K121113 · Biopsy Sciences, Inc. Hydromark Brest Biosy Site Marker · Biopsy Sciences, LLC · 2012K090501 · Biopsy Sciences Hydromark Breast Biopsy Site Marker, Models 4005-02-15-T1, 4005-02-15-S1, 4005-03-15-T1, 4005-03-15-S1 · Biopsy Sciences, LLC · 2009K083006 · Biopsy Sciences, Inc., Hydromark Breast Biopsy Site Marker · Biopsy Sciences, LLC · 2009K060769 · Hydromark Biopsy Site Marker · Biopsy Sciences, LLC · 2006K053518 · Interv Brand V-Mark Breast Biopsy Site Marker with Titanium Anchor · Medical Device Technologies, Inc. · 2006K051421 · Inter V Brand V-Mark Breast Biopsy Site Marker with Titanium Anchor · Medical Device Technologies, Inc. · 2005K023694 · Bio-Mark Resorbable Biopsy Site Marker and Bio-Mark Permanent Biopsy Site Marker · Biopsy Sciences, LLC · 2003−50
  1. Root · 7 generations backK023694 Bio-Mark Resorbable Biopsy Site Marker and Bio-Mark Permanent Biopsy…Biopsy Sciences, LLC · 2003
  2. 6 generations backK051421 Inter V Brand V-Mark Breast Biopsy Site Marker with Titanium AnchorMedical Device Technologies, Inc. · 2005
  3. 5 generations backK053518 Interv Brand V-Mark Breast Biopsy Site Marker with Titanium AnchorMedical Device Technologies, Inc. · 2006
  4. 4 generations backK060769 Hydromark Biopsy Site MarkerBiopsy Sciences, LLC · 2006
  5. 3 generations backK083006 Biopsy Sciences, Inc., Hydromark Breast Biopsy Site MarkerBiopsy Sciences, LLC · 2009
  6. 2 generations backK090501 Biopsy Sciences Hydromark Breast Biopsy Site Marker, Models…Biopsy Sciences, LLC · 2009
  7. 1 generation backK121113 Biopsy Sciences, Inc. Hydromark Brest Biosy Site MarkerBiopsy Sciences, LLC · 2012
  8. This deviceK130537 Biopsy Sciences LLC Hydromark Breast Biopsy Site MarkerBiopsy Sciences, LLC · 2013
  9. Descendant · cites it directly · 2 of its ownK161021 HydroMARK Breast Biopsy Site MarkerDevicor Medical Products, Inc. · 2016
  10. Descendant · 2 generations on · 0 of its ownK203097 HydroMARK Breast Biopsy Site MarkersDevicor Medical Products, Inc. · 2020
  11. Descendant · 2 generations on · 0 of its ownK170803 HydroMARK Breast Biopsy Site MarkersDevicor Medical Products, Inc. · 2017

Most influential descendants

Showing 3 of 3 · See all
  • K161021HydroMARK Breast Biopsy Site MarkerDevicor Medical Products, Inc. · 2016 · cites it directly2descendants
  • K203097HydroMARK Breast Biopsy Site MarkersDevicor Medical Products, Inc. · 2020 · 2 generations on0descendants
  • K170803HydroMARK Breast Biopsy Site MarkersDevicor Medical Products, Inc. · 2017 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−7K023694Bio-Mark Resorbable Biopsy Site Marker and Bio-Mark Permanent Biopsy Site MarkerBiopsy Sciences, LLC2003—
−6K051421Inter V Brand V-Mark Breast Biopsy Site Marker with Titanium AnchorMedical Device Technologies, Inc.2005—
−5K053518Interv Brand V-Mark Breast Biopsy Site Marker with Titanium AnchorMedical Device Technologies, Inc.2006—
−4K060769Hydromark Biopsy Site MarkerBiopsy Sciences, LLC2006—
−3K083006Biopsy Sciences, Inc., Hydromark Breast Biopsy Site MarkerBiopsy Sciences, LLC2009—
−2K090501Biopsy Sciences Hydromark Breast Biopsy Site Marker, Models 4005-02-15-T1…Biopsy Sciences, LLC2009—
−1K121113Biopsy Sciences, Inc. Hydromark Brest Biosy Site MarkerBiopsy Sciences, LLC2012—
0 (this device)K130537Biopsy Sciences LLC Hydromark Breast Biopsy Site MarkerBiopsy Sciences, LLC2013—
+1K161021HydroMARK Breast Biopsy Site MarkerDevicor Medical Products, Inc.2016—
+2K203097HydroMARK Breast Biopsy Site MarkersDevicor Medical Products, Inc.2020—
+2K170803HydroMARK Breast Biopsy Site MarkersDevicor Medical Products, Inc.2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710
200410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201610
201710
202010
FIG. 1 — Lineage of K130537, 2003–2020Source: 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K060769Hydromark Biopsy Site Marker
Summary page 1
…Implantable clip Classification Name: Implantable clip per 21 CFR 878.4300, NEU Predicate Devices: Biopsy Sciences H-ydroMark Breast Biopsy Site Marker, K060769 Biopsy Sciences HydroMark Breast Biopsy Site Marker, K083006 Biopsy Sciences HydroM…
Biopsy Sciences, LLC2006—
*K083006Biopsy Sciences, Inc., Hydromark Breast Biopsy Site Marker
Summary page 1
…00, NEU Predicate Devices: Biopsy Sciences H-ydroMark Breast Biopsy Site Marker, K060769 Biopsy Sciences HydroMark Breast Biopsy Site Marker, K083006 Biopsy Sciences HydroMark Breast Biopsy Site Marker, K090501 Biopsy Sciences HydroM…
Biopsy Sciences, LLC2009—
*K090501Biopsy Sciences Hydromark Breast Biopsy Site Marker, Models 4005-02-15-T1…
Summary page 1
…, K060769 Biopsy Sciences HydroMark Breast Biopsy Site Marker, K083006 Biopsy Sciences HydroMark Breast Biopsy Site Marker, K090501 Biopsy Sciences HydroMark Breast Biopsy Site Marker, K 121 113 Device Description: The HydroMark Breas…
Biopsy Sciences, LLC2009—
*K121113Biopsy Sciences, Inc. Hydromark Brest Biosy Site Marker
Summary page 1
…, K083006 Biopsy Sciences HydroMark Breast Biopsy Site Marker, K090501 Biopsy Sciences HydroMark Breast Biopsy Site Marker, K 121 113 Device Description: The HydroMark Breast Biopsy Site Marker contains a resorbable hydrogel component a…
Biopsy Sciences, LLC2012—

Also cleared against K060769: 4 other devices →

What descends from it? (3)

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

NumberDeviceApplicantDecidedDescendants
K161021HydroMARK Breast Biopsy Site MarkerDevicor Medical Products, Inc.20162

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?

  • The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 9 months on median.
  • None of the 9 ancestors has a recall.
  • Of its descendants, K161021 (Devicor Medical Products, Inc., 2016) has gone furthest, with 2 descendants of its own.
  • 4 other devices also cite its predicate K060769.

How does its category compare?

All NEU devices

NEU Marker, Radiographic, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

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?

To mark tissue during a percutaneous breast biopsy procedure, be visible under ultrasound for at least 6 weeks, and be permanently visible by x-ray and MRI.

Indications for use as stated in the FDA summary.

Also cleared against K060769

4 other devices cite the same predicate.

  • K190689SignalMark Breast MarkerView Point Medical, Inc. · 2019
  • K121113Biopsy Sciences, Inc. Hydromark Brest Biosy Site MarkerBiopsy Sciences, LLC · 2012
  • K090501Biopsy Sciences Hydromark Breast Biopsy Site Marker, Models 4005-02-15-T1, 4005-02-15-S1, 4005-03-15-T1…Biopsy Sciences, LLC · 2009
  • K083006Biopsy Sciences, Inc., Hydromark Breast Biopsy Site MarkerBiopsy Sciences, LLC · 2009

More from Biopsy Sciences, LLC

8 FDA decisions under this applicant name. See the company

  • K121113Biopsy Sciences, Inc. Hydromark Brest Biosy Site MarkerBiopsy Sciences, LLC · 2012
  • K090501Biopsy Sciences Hydromark Breast Biopsy Site Marker, Models 4005-02-15-T1, 4005-02-15-S1, 4005-03-15-T1…Biopsy Sciences, LLC · 2009
  • K083006Biopsy Sciences, Inc., Hydromark Breast Biopsy Site MarkerBiopsy Sciences, LLC · 2009
  • K060769Hydromark Biopsy Site MarkerBiopsy Sciences, LLC · 2006
  • K041331Biopsy Sciences, LLC, Lung Biopsy Site MarkerBiopsy Sciences, LLC · 2004

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/K130537 · printed Nov 6, 2026

Cite this page

510(k) Report. “K130537: Biopsy Sciences LLC Hydromark Breast Biopsy Site Marker.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130537

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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