510(k) · Cleared
ClearedMagseed Magnetic Marker Systtem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Endomagnetics Ltd., · NEU Marker, Radiographic, Implantable
Cleared on Feb 16, 2018 as substantially equivalent to K070436 (Carbon Medical Technologies, Inc., 2007) and 2 other predicates after an 88-day review. Its family tree reaches back 9 generations to 2003. 2 later devices descend from it.
- Decided
- Feb 16, 2018
- Review
- 88 days
- Class
- Class II
- Product code
- NEU
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K023694 (2003). 29 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 backK120804 Cianna Medical Tissue Marker and Delivery SystemCianna Medical · 2013
- 2 generations backK153044 Sentimag System, Sentimark Magnetic Marker SystermEndomagnetics Ltd., · 2016
- 1 generation backK163541 Magseed Magnetic Marker SystemEndomagnetics Ltd., · 2017
- This deviceK173587 Magseed Magnetic Marker SysttemEndomagnetics Ltd., · 2018
- Descendant · cites it directly · 0 of its ownK232865 Magseed Pro Magnetic Marker SystemEndomagnetics Ltd., · 2024 · Recalled
- Descendant · cites it directly · 0 of its ownK222832 Sentimag SystemEndomagnetics Ltd., · 2023
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 backK120804 Cianna Medical Tissue Marker and Delivery SystemCianna Medical · 2013
- 2 generations backK153044 Sentimag System, Sentimark Magnetic Marker SystermEndomagnetics Ltd., · 2016
- 1 generation backK163541 Magseed Magnetic Marker SystemEndomagnetics Ltd., · 2017
- This deviceK173587 Magseed Magnetic Marker SysttemEndomagnetics Ltd., · 2018
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 |
|---|---|---|---|---|---|
| −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 | K120804 | Cianna Medical Tissue Marker and Delivery System | Cianna Medical | 2013 | — |
| −2 | K153044 | Sentimag System, Sentimark Magnetic Marker Systerm | Endomagnetics Ltd., | 2016 | — |
| −1 | K163541 | Magseed Magnetic Marker System | Endomagnetics Ltd., | 2017 | — |
| 0 (this device) | K173587 | Magseed Magnetic Marker Systtem | Endomagnetics Ltd., | 2018 | — |
| +1 | K232865 | Magseed Pro Magnetic Marker System | Endomagnetics Ltd., | 2024 | 2 |
| +1 | K222832 | Sentimag System | Endomagnetics Ltd., | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 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? (3)
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 |
|---|---|---|---|
| * | K070436 | Biomarc Gold Tissue MarkerSummary page 5…K173587 Page 2 of 2 5.3 PREDICATE DEVICES 1. Carbon Medical Technolgies, Inc. BiomarC Gold Tissue Marker (K070436). 2. Sentimag System, Sentimark (Magseed) Magnetic Marker System (K153044 & K163541) 5.4 DESCRIPTION OF DEVIC… | 2007 |
| * | K153044 | Sentimag System, Sentimark Magnetic Marker SystermSummary page 5…PREDICATE DEVICES 1. Carbon Medical Technolgies, Inc. BiomarC Gold Tissue Marker (K070436). 2. Sentimag System, Sentimark (Magseed) Magnetic Marker System (K153044 & K163541) 5.4 DESCRIPTION OF DEVICE The Endomag Magseed® Magnetic Marker is intended for use as a tissue marker.… | 2016 |
| * | K163541 | Magseed Magnetic Marker SystemSummary page 5…1. Carbon Medical Technolgies, Inc. BiomarC Gold Tissue Marker (K070436). 2. Sentimag System, Sentimark (Magseed) Magnetic Marker System (K153044 & K163541) 5.4 DESCRIPTION OF DEVICE The Endomag Magseed® Magnetic Marker is intended for use as a tissue marker. The marker is visib… | 2017 |
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 15 years and passes through 4 companies; a new generation was cleared every 1.1 years on median.
- 3 of the 29 ancestors have a recall of any class.
- Of its descendants, K232865 (Endomagnetics Ltd.,, 2024) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K070436.
How does its category compare?
All NEU devicesNEU Marker, Radiographic, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 Endomag Magseed® Magnetic Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173587 · printed Nov 4, 2026
Cite this page
510(k) Report. “K173587: Magseed Magnetic Marker Systtem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K173587
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