510(k) Report

510(k) · Cleared

Cleared

Hydromark Biopsy Site Marker

K060769510(k) TraditionalCleared Jul 25, 2006125-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 Jul 25, 2006 as substantially equivalent to K023694 (Biopsy Sciences, LLC, 2003) and 3 other predicates after a 125-day review. Its family tree reaches back 3 generations to 2003. 30 later devices descend from it.

Decided
Jul 25, 2006
Review
125 days
Class
Class II
Product code
NEU
Recalls
None
Predicates
4

Its longest line of descent runs back 3 generations to K023694 (2003). 5 ancestors in all, the oldest K970817 (1997). 30 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2004: 1 other ancestor1997: 1 other ancestor2019: 1 descendant cleared2009: 2 descendants cleared2012: 1 descendant cleared2013: 3 descendants cleared2021: 3 descendants cleared2016: 2 descendants cleared2017: 2 descendants cleared2020: 1 descendant cleared2022: 2 descendants cleared2023: 5 descendants cleared2018: 1 descendant cleared2024: 5 descendants cleared2026: 1 descendant cleared2025: 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. · 20061995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 5 descendants2 generations forward: 3 descendants3 generations forward: 5 descendants4 generations forward: 5 descendants5 generations forward: 5 descendants6 generations forward: 2 descendants7 generations forward: 2 descendants8 generations forward: 2 descendants9 generations forward: 1 descendant K053518 · 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 · 20030+5
  1. Root · 3 generations backK023694 Bio-Mark Resorbable Biopsy Site Marker and Bio-Mark Permanent Biopsy…Biopsy Sciences, LLC · 2003
  2. 2 generations backK051421 Inter V Brand V-Mark Breast Biopsy Site Marker with Titanium AnchorMedical Device Technologies, Inc. · 2005
  3. 1 generation backK053518 Interv Brand V-Mark Breast Biopsy Site Marker with Titanium AnchorMedical Device Technologies, Inc. · 2006
  4. This deviceK060769 Hydromark Biopsy Site MarkerBiopsy Sciences, LLC · 2006
  5. Descendant · cites it directly · 28 of its ownK083006 Biopsy Sciences, Inc., Hydromark Breast Biopsy Site MarkerBiopsy Sciences, LLC · 2009
  6. Descendant · cites it directly · 27 of its ownK090501 Biopsy Sciences Hydromark Breast Biopsy Site Marker, Models…Biopsy Sciences, LLC · 2009
  7. Descendant · 2 generations on · 15 of its ownK120804 Cianna Medical Tissue Marker and Delivery SystemCianna Medical · 2013
  8. Descendant · 3 generations on · 13 of its ownK153044 Sentimag System, Sentimark Magnetic Marker SystermEndomagnetics Ltd., · 2016
  9. Descendant · 4 generations on · 12 of its ownK163541 Magseed Magnetic Marker SystemEndomagnetics Ltd., · 2017

Showing 5 of 30 descendants. See all descendants

Descendants cleared per year

2009: 22012: 12013: 32016: 22017: 22018: 12019: 12020: 12021: 32022: 22023: 52024: 52025: 12026: 1
2009high 5 (2023) · low 0 (2010)2026

Most influential descendants

Showing 5 of 30 · See all
  • K083006Biopsy Sciences, Inc., Hydromark Breast Biopsy Site MarkerBiopsy Sciences, LLC · 2009 · cites it directly28descendants
  • K090501Biopsy Sciences Hydromark Breast Biopsy Site Marker, Models 4005-02-15-T1…Biopsy Sciences, LLC · 2009 · cites it directly27descendants
  • K120804Cianna Medical Tissue Marker and Delivery SystemCianna Medical · 2013 · 2 generations on15descendants
  • K153044Sentimag System, Sentimark Magnetic Marker SystermEndomagnetics Ltd., · 2016 · 3 generations on13descendants
  • K163541Magseed Magnetic Marker SystemEndomagnetics Ltd., · 2017 · 4 generations on12descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K023694Bio-Mark Resorbable Biopsy Site Marker and Bio-Mark Permanent Biopsy Site MarkerBiopsy Sciences, LLC2003—
−2K051421Inter V Brand V-Mark Breast Biopsy Site Marker with Titanium AnchorMedical Device Technologies, Inc.2005—
−1K053518Interv Brand V-Mark Breast Biopsy Site Marker with Titanium AnchorMedical Device Technologies, Inc.2006—
0 (this device)K060769Hydromark Biopsy Site MarkerBiopsy Sciences, LLC2006—
+1K083006Biopsy Sciences, Inc., Hydromark Breast Biopsy Site MarkerBiopsy Sciences, LLC2009—
+1K090501Biopsy Sciences Hydromark Breast Biopsy Site Marker, Models 4005-02-15-T1…Biopsy Sciences, LLC2009—
+2K120804Cianna Medical Tissue Marker and Delivery SystemCianna Medical2013—
+3K153044Sentimag System, Sentimark Magnetic Marker SystermEndomagnetics Ltd.,2016—
+4K163541Magseed Magnetic Marker SystemEndomagnetics Ltd.,2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710
200410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200920
201210
201330
201620
201720
201810
201910
202010
202130
202220
202350
202450
202510
202610
FIG. 1 — Lineage of K060769, 2003–2026Source: 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
*K023694Bio-Mark Resorbable Biopsy Site Marker and Bio-Mark Permanent Biopsy Site Marker
Summary page 1
…me: Biopsy site marker Classification Name: Implantable staple per 21 CFR 878.4750, FZP Predicate Devices: Biopsy Sciences Bio-Mark Biopsy Site Marker, K023694 Biopsy Sciences Bio-Seal Lung Biopsy Site Marker, K041331 InterV brand V-Mark Bre…
Biopsy Sciences, LLC2003—
*K041331Biopsy Sciences, LLC, Lung Biopsy Site Marker
Summary page 1
…CFR 878.4750, FZP Predicate Devices: Biopsy Sciences Bio-Mark Biopsy Site Marker, K023694 Biopsy Sciences Bio-Seal Lung Biopsy Site Marker, K041331 InterV brand V-Mark Breast Biopsy Site Marker with Titanium Anchor, K053518…
Biopsy Sciences, LLC2004—
*K053518Interv Brand V-Mark Breast Biopsy Site Marker with Titanium Anchor
Summary page 1
…sy Sciences Bio-Seal Lung Biopsy Site Marker, K041331 InterV brand V-Mark Breast Biopsy Site Marker with Titanium Anchor, K053518 J& MicroMark Biopsy Clip, K970817 Device Description: The Biopsy Sciences HydroMark Biospy Site Mark…
Medical Device Technologies, Inc.2006—
*K970817Micromark Clip
Summary page 1
…InterV brand V-Mark Breast Biopsy Site Marker with Titanium Anchor, K053518 J& MicroMark Biopsy Clip, K970817 Device Description: The Biopsy Sciences HydroMark Biospy Site Markers are made of resorbable FocalSe…
Biopsys Medical, Inc.1997—

Also cleared against K023694: 1 other device →

What descends from it? (30)

See all 30

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

NumberDeviceApplicantDecidedDescendants
K083006Biopsy Sciences, Inc., Hydromark Breast Biopsy Site MarkerBiopsy Sciences, LLC200928
K090501Biopsy Sciences Hydromark Breast Biopsy Site Marker, Models 4005-02-15-T1…Biopsy Sciences, LLC200927
K121113Biopsy Sciences, Inc. Hydromark Brest Biosy Site MarkerBiopsy Sciences, LLC201210
K130537Biopsy Sciences LLC Hydromark Breast Biopsy Site MarkerBiopsy Sciences, LLC20133
K190689SignalMark Breast MarkerView Point Medical, Inc.20190

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 3 years and passes through 2 companies; a new generation was cleared every 6 months on median.
  • None of the 5 ancestors has a recall.
  • Of its descendants, K083006 (Biopsy Sciences, LLC, 2009) has gone furthest, with 28 descendants of its own.
  • 1 other device also cites its predicate K023694.

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 Biopsy Sciences LLC HydroMark Biopsy Site Marker is intended 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 K023694

1 other device cites the same predicate.

  • K051421Inter V Brand V-Mark Breast Biopsy Site Marker with Titanium AnchorMedical Device Technologies, Inc. · 2005

More from Biopsy Sciences, LLC

8 FDA decisions under this applicant name. See the company

  • K130537Biopsy Sciences LLC Hydromark Breast Biopsy Site MarkerBiopsy Sciences, LLC · 2013
  • 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
  • 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/K060769 · printed Nov 4, 2026

Cite this page

510(k) Report. “K060769: Hydromark Biopsy Site Marker.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060769

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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