510(k) · Cleared
Recalled · Class II · 2026HydroMARK 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 Apr 21, 2022 as substantially equivalent to K210752 (Devicor Medical Products, Inc., 2021) after a 283-day review. Its family tree reaches back 8 generations to 2003. 4 later devices descend from it. It has been recalled once.
- Decided
- Apr 21, 2022
- Review
- 283 days
- Class
- Class II
- Product code
- NEU
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 8 generations to K023694 (2003). 10 ancestors in all, the oldest K970817 (1997). 4 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 backK210752 HydroMARK Breast Biopsy Site MarkerDevicor Medical Products, Inc. · 2021 · Recalled
- This deviceK212158 HydroMARK Breast Biopsy Site MarkerDevicor Medical Products, Inc. · 2022
- Descendant · cites it directly · 2 of its ownK221961 HydroMARK Plus Breast Biopsy Site MarkerDevicor Medical Products, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK253761 HydroMARK™ Plus Breast Biopsy Site Marker (Dragonfly Shape)…Devicor Medical Products, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK240527 HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape)…Devicor Medical Products, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK232615 LumiMARK™ Biopsy Site Marker (LM0215T (Tulip Shape)); LumiMARK™…Devicor Medical Products, Inc. · 2024
Most influential descendants
Showing 4 of 4 · See all- K221961HydroMARK Plus Breast Biopsy Site MarkerDevicor Medical Products, Inc. · 2023 · cites it directly2descendants
- K253761HydroMARK™ Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK™ Plus Breast…Devicor Medical Products, Inc. · 2026 · 2 generations on0descendants
- K240527HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape) (4010-02-15-T6)Devicor Medical Products, Inc. · 2024 · 2 generations on0descendants
- K232615LumiMARK™ Biopsy Site Marker (LM0215T (Tulip Shape)); LumiMARK™ Biopsy Site Marker…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 |
|---|---|---|---|---|---|
| −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 | K210752 | HydroMARK Breast Biopsy Site Marker | Devicor Medical Products, Inc. | 2021 | 1 |
| 0 (this device) | K212158 | HydroMARK Breast Biopsy Site Marker | Devicor Medical Products, Inc. | 2022 | — |
| +1 | K221961 | HydroMARK Plus Breast Biopsy Site Marker | Devicor Medical Products, Inc. | 2023 | — |
| +2 | K253761 | HydroMARK™ Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK™ Plus… | Devicor Medical Products, Inc. | 2026 | — |
| +2 | K240527 | HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape) (4010-02-15-T6) | Devicor Medical Products, Inc. | 2024 | — |
| +1 | K232615 | LumiMARK™ Biopsy Site Marker (LM0215T (Tulip Shape)); LumiMARK™ Biopsy Site… | 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 |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 2 | 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 |
|---|---|---|---|
| * | K210752 | HydroMARK Breast Biopsy Site MarkerSummary page 5…K212158 Page 2 of 8 • Devicor Medical Products Inc. HydroMARK Breast Biopsy Site Marker (K210752) [predicate device] Predicate The Devicor Medical Products, Inc. HydroMARK Breast Biopsy Site Marker [subject Device… | 2021 |
What descends from it? (4)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 24, 2026 | Class II | Z-2239-2026 | Labeling mix-ups | Incorrect inner package labeling. Boxes labeled 4010-02-15-T3 markers may contain individual packages labeled as T4 Markers. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 2.5 years on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K221961 (Devicor Medical Products, Inc., 2023) has gone furthest, with 2 descendants of its own.
How does its category compare?
All NEU devicesNEU Marker, Radiographic, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K212158 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212158: 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/K212158
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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