510(k) Report

510(k) · Cleared

Cleared

Bio-Mark Resorbable Biopsy Site Marker and Bio-Mark Permanent Biopsy Site Marker

K023694510(k) TraditionalCleared Mar 17, 2003136-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 17, 2003 after a 136-day review. The FDA summary names its predicate without a number. 33 later devices descend from it.

Decided
Mar 17, 2003
Review
136 days
Class
Class II
Product code
NEU
Recalls
None
Predicates
0

33 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2006: 2 descendants cleared2005: 1 descendant cleared2019: 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 cleared200020052010201520202025
  1. This deviceK023694 Bio-Mark Resorbable Biopsy Site Marker and Bio-Mark Permanent Biopsy…Biopsy Sciences, LLC · 2003
  2. Descendant · cites it directly · 32 of its ownK051421 Inter V Brand V-Mark Breast Biopsy Site Marker with Titanium AnchorMedical Device Technologies, Inc. · 2005
  3. Descendant · 2 generations on · 31 of its ownK053518 Interv Brand V-Mark Breast Biopsy Site Marker with Titanium AnchorMedical Device Technologies, Inc. · 2006
  4. Descendant · cites it directly · 30 of its ownK060769 Hydromark Biopsy Site MarkerBiopsy Sciences, LLC · 2006
  5. Descendant · 2 generations on · 28 of its ownK083006 Biopsy Sciences, Inc., Hydromark Breast Biopsy Site MarkerBiopsy Sciences, LLC · 2009
  6. Descendant · 2 generations on · 27 of its ownK090501 Biopsy Sciences Hydromark Breast Biopsy Site Marker, Models…Biopsy Sciences, LLC · 2009

Showing 5 of 33 descendants. See all descendants

Descendants cleared per year

2005: 12006: 22009: 22012: 12013: 32016: 22017: 22018: 12019: 12020: 12021: 32022: 22023: 52024: 52025: 12026: 1
2005high 5 (2023) · low 0 (2007)2026

Most influential descendants

Showing 5 of 33 · See all
  • K051421Inter V Brand V-Mark Breast Biopsy Site Marker with Titanium AnchorMedical Device Technologies, Inc. · 2005 · cites it directly32descendants
  • K053518Interv Brand V-Mark Breast Biopsy Site Marker with Titanium AnchorMedical Device Technologies, Inc. · 2006 · 2 generations on31descendants
  • K060769Hydromark Biopsy Site MarkerBiopsy Sciences, LLC · 2006 · cites it directly30descendants
  • K083006Biopsy Sciences, Inc., Hydromark Breast Biopsy Site MarkerBiopsy Sciences, LLC · 2009 · 2 generations on28descendants
  • K090501Biopsy Sciences Hydromark Breast Biopsy Site Marker, Models 4005-02-15-T1…Biopsy Sciences, LLC · 2009 · 2 generations on27descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K023694Bio-Mark Resorbable Biopsy Site Marker and Bio-Mark Permanent Biopsy Site MarkerBiopsy Sciences, LLC2003—
+1K051421Inter V Brand V-Mark Breast Biopsy Site Marker with Titanium AnchorMedical Device Technologies, Inc.2005—
+2K053518Interv Brand V-Mark Breast Biopsy Site Marker with Titanium AnchorMedical Device Technologies, Inc.2006—
+1K060769Hydromark Biopsy Site MarkerBiopsy Sciences, LLC2006—
+2K083006Biopsy Sciences, Inc., Hydromark Breast Biopsy Site MarkerBiopsy Sciences, LLC2009—
+2K090501Biopsy Sciences Hydromark Breast Biopsy Site Marker, Models 4005-02-15-T1…Biopsy Sciences, LLC2009—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200620
200920
201210
201330
201620
201720
201810
201910
202010
202130
202220
202350
202450
202510
202610
FIG. 1 — Lineage of K023694, 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
*—J&J Ethicon MicroMark
Named without a submission number
—
*—Ultraclip Tissue Marker
Named without a submission number
—
*—SenoRx Gel Mark Biopsy Site Marker
Named without a submission number
—
*—Vivant Medical Biopsy Marker System
Named without a submission number
—

What descends from it? (33)

See all 33

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

NumberDeviceApplicantDecidedDescendants
K051421Inter V Brand V-Mark Breast Biopsy Site Marker with Titanium AnchorMedical Device Technologies, Inc.200532
K060769Hydromark Biopsy Site MarkerBiopsy Sciences, LLC200630

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, K051421 (Medical Device Technologies, Inc., 2005) has gone furthest, with 32 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 Biopsy Sciences, LLC., Bio-MARK Resorbable Biopsy Site Marker is intended to mark tissue during a percutaneous breast biopsy procedure, and be visible under MRI, ultrasound and x-ray for at least 6 weeks.

The Bio-MARK Permanent Biopsy Site Marker is intended to mark tissue during a percutaneous breast biopsy procedure, be visible under MRI and ultrasound for at least 6 weeks, and be permanently visible by fluoroscopy.

Indications for use as stated in the FDA summary.

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
  • K060769Hydromark Biopsy Site MarkerBiopsy Sciences, LLC · 2006

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/K023694 · printed Nov 5, 2026

Cite this page

510(k) Report. “K023694: Bio-Mark Resorbable Biopsy Site Marker and Bio-Mark Permanent Biopsy Site Marker.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K023694

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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