510(k) · Cleared
ClearedHydroMARK Breast Biopsy Site Markers
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 Dec 16, 2020 as substantially equivalent to K161021 (Devicor Medical Products, Inc., 2016) after a 63-day review. Its family tree reaches back 9 generations to 2003.
- Decided
- Dec 16, 2020
- Review
- 63 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). No later device cites it as a predicate yet.
- 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 backK130537 Biopsy Sciences LLC Hydromark Breast Biopsy Site MarkerBiopsy Sciences, LLC · 2013
- 1 generation backK161021 HydroMARK Breast Biopsy Site MarkerDevicor Medical Products, Inc. · 2016
- This deviceK203097 HydroMARK Breast Biopsy Site MarkersDevicor Medical Products, Inc. · 2020
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 backK130537 Biopsy Sciences LLC Hydromark Breast Biopsy Site MarkerBiopsy Sciences, LLC · 2013
- 1 generation backK161021 HydroMARK Breast Biopsy Site MarkerDevicor Medical Products, Inc. · 2016
- This deviceK203097 HydroMARK Breast Biopsy Site MarkersDevicor Medical Products, Inc. · 2020
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 | K130537 | Biopsy Sciences LLC Hydromark Breast Biopsy Site Marker | Biopsy Sciences, LLC | 2013 | — |
| −1 | K161021 | HydroMARK Breast Biopsy Site Marker | Devicor Medical Products, Inc. | 2016 | — |
| 0 (this device) | K203097 | HydroMARK Breast Biopsy Site Markers | Devicor Medical Products, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2004 | 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 |
|---|---|---|---|
| * | K161021 | HydroMARK Breast Biopsy Site MarkerSummary page 4…substantially equivalent (SE) to the Sponsor’s own predicate device: • Devicor Medical Products Inc. HydroMARK® Breast Biopsy Site Marker (K161021) Predicate [predicate device] Device: The Devicor Medical Products, Inc. HydroMARK® Breast Biopsy S… | 2016 |
| † | K121113 | Biopsy Sciences, Inc. Hydromark Brest Biosy Site Marker | 2012 |
| † | K130537 | Biopsy Sciences LLC Hydromark Breast Biopsy Site Marker | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
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 17 years and passes through 3 companies; a new generation was cleared every 2.5 years on median.
- None of the 11 ancestors has a recall.
- 1 other device also cites its predicate K161021.
How does its category compare?
All NEU devicesNEU Marker, Radiographic, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K203097 · printed Nov 5, 2026
Cite this page
510(k) Report. “K203097: HydroMARK Breast Biopsy Site Markers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K203097
Report an extraction error
Are you the manufacturer?
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