510(k) · Cleared
ClearedHydroMARK Breast Biopsy Site Marker
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Devicor Medical Products, Inc. · NEU Marker, Radiographic, Implantable
Cleared on May 5, 2016 as substantially equivalent to K121113 (Biopsy Sciences, LLC, 2012) and 1 other predicate after a 23-day review. Its family tree reaches back 8 generations to 2003. 2 later devices descend from it.
- Decided
- May 5, 2016
- Review
- 23 days
- Class
- Class II
- Product code
- NEU
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K023694 (2003). 10 ancestors in all, the oldest K970817 (1997). 2 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK023694 Bio-Mark Resorbable Biopsy Site Marker and Bio-Mark Permanent Biopsy…Biopsy Sciences, LLC · 2003
- 7 generations backK051421 Inter V Brand V-Mark Breast Biopsy Site Marker with Titanium AnchorMedical Device Technologies, Inc. · 2005
- 6 generations backK053518 Interv Brand V-Mark Breast Biopsy Site Marker with Titanium AnchorMedical Device Technologies, Inc. · 2006
- 5 generations backK060769 Hydromark Biopsy Site MarkerBiopsy Sciences, LLC · 2006
- 4 generations backK083006 Biopsy Sciences, Inc., Hydromark Breast Biopsy Site MarkerBiopsy Sciences, LLC · 2009
- 3 generations backK090501 Biopsy Sciences Hydromark Breast Biopsy Site Marker, Models…Biopsy Sciences, LLC · 2009
- 2 generations backK121113 Biopsy Sciences, Inc. Hydromark Brest Biosy Site MarkerBiopsy Sciences, LLC · 2012
- 1 generation backK130537 Biopsy Sciences LLC Hydromark Breast Biopsy Site MarkerBiopsy Sciences, LLC · 2013
- This deviceK161021 HydroMARK Breast Biopsy Site MarkerDevicor Medical Products, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK203097 HydroMARK Breast Biopsy Site MarkersDevicor Medical Products, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK170803 HydroMARK Breast Biopsy Site MarkersDevicor Medical Products, Inc. · 2017
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K023694 | Bio-Mark Resorbable Biopsy Site Marker and Bio-Mark Permanent Biopsy Site Marker | Biopsy Sciences, LLC | 2003 | — |
| −7 | K051421 | Inter V Brand V-Mark Breast Biopsy Site Marker with Titanium Anchor | Medical Device Technologies, Inc. | 2005 | — |
| −6 | K053518 | Interv Brand V-Mark Breast Biopsy Site Marker with Titanium Anchor | Medical Device Technologies, Inc. | 2006 | — |
| −5 | K060769 | Hydromark Biopsy Site Marker | Biopsy Sciences, LLC | 2006 | — |
| −4 | K083006 | Biopsy Sciences, Inc., Hydromark Breast Biopsy Site Marker | Biopsy Sciences, LLC | 2009 | — |
| −3 | K090501 | Biopsy Sciences Hydromark Breast Biopsy Site Marker, Models 4005-02-15-T1… | Biopsy Sciences, LLC | 2009 | — |
| −2 | K121113 | Biopsy Sciences, Inc. Hydromark Brest Biosy Site Marker | Biopsy Sciences, LLC | 2012 | — |
| −1 | K130537 | Biopsy Sciences LLC Hydromark Breast Biopsy Site Marker | Biopsy Sciences, LLC | 2013 | — |
| 0 (this device) | K161021 | HydroMARK Breast Biopsy Site Marker | Devicor Medical Products, Inc. | 2016 | — |
| +1 | K203097 | HydroMARK Breast Biopsy Site Markers | Devicor Medical Products, Inc. | 2020 | — |
| +1 | K170803 | HydroMARK Breast Biopsy Site Markers | Devicor Medical Products, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
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 K240042 MOLLI 2 Systemscore 14.4 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 | Decided |
|---|---|---|---|
| * | K121113 | Biopsy Sciences, Inc. Hydromark Brest Biosy Site MarkerSummary page 4…ion: Class II Classification Name: Implantable clip per 21 CFR 878.4300, NEU Predicate Devices: Biopsy Sciences HydroMark Breast Biopsy Site Marker, K121113 Biopsy Sciences HydroMark Breast Biopsy Site Marker, K130537 Device Description: The HydroMARK® Breas… | 2012 |
| * | K130537 | Biopsy Sciences LLC Hydromark Breast Biopsy Site MarkerSummary page 4…Predicate Devices: Biopsy Sciences HydroMark Breast Biopsy Site Marker, K121113 Biopsy Sciences HydroMark Breast Biopsy Site Marker, K130537 Device Description: The HydroMARK® Breast Biopsy Site Marker contains a reabsorbable hydrogel component and… | 2013 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 13 years and passes through 3 companies; a new generation was cleared every 2.5 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K203097 (Devicor Medical Products, Inc., 2020) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K121113.
How does its category compare?
All NEU devicesNEU Marker, Radiographic, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · NEU
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NEU
99in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NEU
2in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · NEU
411in 2025
MAUDE reports naming product code NEU, 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 | 4 | 94 | 0 | 5 |
| 2008 | 7 | 107 | 0 | 5 |
| 2009 | 4 | 70 | 0 | 30 |
| 2010 | 5 | 69 | 0 | 12 |
| 2011 | 3 | 145 | 1 | 18 |
| 2012 | 3 | 120 | 0 | 54 |
| 2013 | 7 | 49 | 0 | 60 |
| 2014 | 3 | 48 | 0 | 38 |
| 2015 | 7 | 111 | 0 | 120 |
| 2016 | 2 | — | 0 | 56 |
| 2017 | 4 | 115 | 1 | 69 |
| 2018 | 8 | 89 | 0 | 66 |
| 2019 | 5 | 149 | 0 | 58 |
| 2020 | 3 | 169 | 0 | 45 |
| 2021 | 3 | 46 | 0 | 82 |
| 2022 | 2 | — | 1 | 100 |
| 2023 | 4 | 136 | 0 | 142 |
| 2024 | 10 | 267 | 2 (1) | 247 |
| 2025 | 5 | 99 | 2 | 411 |
| 2026 | 1 | — | 2 | — |
What is it indicated for?
The HydroMARK® Breast Biopsy Site Marker is indicated 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.
https://510kreport.com/device/K161021 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161021: 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/K161021
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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