510(k) · Cleared
ClearedHydroMARK Plus 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 Jul 13, 2023 as substantially equivalent to K212158 (Devicor Medical Products, Inc., 2022) after a 373-day review. Its family tree reaches back 9 generations to 2003. 2 later devices descend from it.
- Decided
- Jul 13, 2023
- Review
- 373 days
- Class
- Class II
- Product code
- NEU
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K023694 (2003). 11 ancestors in all, the oldest K970817 (1997). 2 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK023694 Bio-Mark Resorbable Biopsy Site Marker and Bio-Mark Permanent Biopsy…Biopsy Sciences, LLC · 2003
- 5 generations between
- 3 generations backK121113 Biopsy Sciences, Inc. Hydromark Brest Biosy Site MarkerBiopsy Sciences, LLC · 2012
- 2 generations backK210752 HydroMARK Breast Biopsy Site MarkerDevicor Medical Products, Inc. · 2021 · Recalled
- 1 generation backK212158 HydroMARK Breast Biopsy Site MarkerDevicor Medical Products, Inc. · 2022 · Recalled
- This deviceK221961 HydroMARK Plus Breast Biopsy Site MarkerDevicor Medical Products, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK253761 HydroMARK™ Plus Breast Biopsy Site Marker (Dragonfly Shape)…Devicor Medical Products, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK240527 HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape)…Devicor Medical Products, Inc. · 2024
Show all 9 generations
- Root · 9 generations backK023694 Bio-Mark Resorbable Biopsy Site Marker and Bio-Mark Permanent Biopsy…Biopsy Sciences, LLC · 2003
- 8 generations backK051421 Inter V Brand V-Mark Breast Biopsy Site Marker with Titanium AnchorMedical Device Technologies, Inc. · 2005
- 7 generations backK053518 Interv Brand V-Mark Breast Biopsy Site Marker with Titanium AnchorMedical Device Technologies, Inc. · 2006
- 6 generations backK060769 Hydromark Biopsy Site MarkerBiopsy Sciences, LLC · 2006
- 5 generations backK083006 Biopsy Sciences, Inc., Hydromark Breast Biopsy Site MarkerBiopsy Sciences, LLC · 2009
- 4 generations backK090501 Biopsy Sciences Hydromark Breast Biopsy Site Marker, Models…Biopsy Sciences, LLC · 2009
- 3 generations backK121113 Biopsy Sciences, Inc. Hydromark Brest Biosy Site MarkerBiopsy Sciences, LLC · 2012
- 2 generations backK210752 HydroMARK Breast Biopsy Site MarkerDevicor Medical Products, Inc. · 2021 · Recalled
- 1 generation backK212158 HydroMARK Breast Biopsy Site MarkerDevicor Medical Products, Inc. · 2022 · Recalled
- This deviceK221961 HydroMARK Plus Breast Biopsy Site MarkerDevicor Medical Products, Inc. · 2023
Most influential descendants
Showing 2 of 2 · See all- K253761HydroMARK™ Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK™ Plus Breast…Devicor Medical Products, Inc. · 2026 · cites it directly0descendants
- K240527HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape) (4010-02-15-T6)Devicor Medical Products, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K023694 | Bio-Mark Resorbable Biopsy Site Marker and Bio-Mark Permanent Biopsy Site Marker | Biopsy Sciences, LLC | 2003 | — |
| −8 | K051421 | Inter V Brand V-Mark Breast Biopsy Site Marker with Titanium Anchor | Medical Device Technologies, Inc. | 2005 | — |
| −7 | K053518 | Interv Brand V-Mark Breast Biopsy Site Marker with Titanium Anchor | Medical Device Technologies, Inc. | 2006 | — |
| −6 | K060769 | Hydromark Biopsy Site Marker | Biopsy Sciences, LLC | 2006 | — |
| −5 | K083006 | Biopsy Sciences, Inc., Hydromark Breast Biopsy Site Marker | Biopsy Sciences, LLC | 2009 | — |
| −4 | K090501 | Biopsy Sciences Hydromark Breast Biopsy Site Marker, Models 4005-02-15-T1… | Biopsy Sciences, LLC | 2009 | — |
| −3 | K121113 | Biopsy Sciences, Inc. Hydromark Brest Biosy Site Marker | Biopsy Sciences, LLC | 2012 | — |
| −2 | K210752 | HydroMARK Breast Biopsy Site Marker | Devicor Medical Products, Inc. | 2021 | 1 |
| −1 | K212158 | HydroMARK Breast Biopsy Site Marker | Devicor Medical Products, Inc. | 2022 | 1 |
| 0 (this device) | K221961 | HydroMARK Plus Breast Biopsy Site Marker | Devicor Medical Products, Inc. | 2023 | — |
| +1 | K253761 | HydroMARK™ Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK™ Plus… | Devicor Medical Products, Inc. | 2026 | — |
| +1 | K240527 | HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape) (4010-02-15-T6) | Devicor Medical Products, Inc. | 2024 | — |
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 |
|---|---|---|
| 2024 | 1 | 0 |
| 2026 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K212158 | HydroMARK Breast Biopsy Site MarkerSummary page 6…edicate devices: Devicor Medical Products Inc. HydroMARK™ Breast Biopsy Site Marker (K212158) [predicate devices] The Devicor Medical Products, Inc. HydroMARK™ Plus Breast Biopsy Site Marker… | 2022 |
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 20 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
- 2 of the 11 ancestors have a recall of any class.
- Of its descendants, K253761 (Devicor Medical Products, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K212158.
How does its category compare?
All NEU devicesNEU Marker, Radiographic, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?
HydroMARK™ Plus Breast Biopsy Site Marker is intended to mark tissue during a percutaneous breast biopsy procedure, including axillary lymph nodes, 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/K221961 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221961: HydroMARK Plus 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/K221961
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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