510(k) · Cleared
ClearedBiopsy Site Marker
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Senorx, Inc. · FZP Clip, Implantable
Cleared on Jul 16, 2001 after a 70-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 of the 12 devices in its family, counting itself, have a Class I recall. 11 later devices descend from it.
- Decided
- Jul 16, 2001
- Review
- 70 days
- Class
- Class II
- Product code
- FZP
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 2 citing it directly. 2 of the 12 devices in this family, counting this one, have a Class I recall.
- This deviceK011402 Biopsy Site MarkerSenorx, Inc. · 2001
- Descendant · cites it directly · 8 of its ownK113202 Tissue MarkerFocal Therapeutics · 2012
- Descendant · 2 generations on · 7 of its ownK143484 BioZorb MarkerFocal Therapeutics · 2015 · Recalled (Class I)
- Descendant · 3 generations on · 5 of its ownK152070 BioZorb LP MarkerFocal Therapeutics · 2015 · Recalled (Class I)
- Descendant · 3 generations on · 1 of its ownK180640 SmartClip Soft Tissue MarkerElucent Medical, Inc. · 2018
- Descendant · cites it directly · 1 of its ownK080698 Gel Mark Ultracor Biopsy Site Marker, Model: Gmuc-17GGPSenorx, Inc. · 2008
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 11 · See all- K113202Tissue MarkerFocal Therapeutics · 2012 · cites it directly8descendants
- K143484BioZorb MarkerFocal Therapeutics · 2015 · 2 generations on7descendants
- K152070BioZorb LP MarkerFocal Therapeutics · 2015 · 3 generations on5descendants
- K180640SmartClip Soft Tissue MarkerElucent Medical, Inc. · 2018 · 3 generations on1descendant
- K080698Gel Mark Ultracor Biopsy Site Marker, Model: Gmuc-17GGPSenorx, Inc. · 2008 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011402 | Biopsy Site Marker | Senorx, Inc. | 2001 | — |
| +1 | K113202 | Tissue Marker | Focal Therapeutics | 2012 | — |
| +2 | K143484 | BioZorb Marker | Focal Therapeutics | 2015 | Class I |
| +3 | K152070 | BioZorb LP Marker | Focal Therapeutics | 2015 | Class I |
| +3 | K180640 | SmartClip Soft Tissue Marker | Elucent Medical, Inc. | 2018 | — |
| +1 | K080698 | Gel Mark Ultracor Biopsy Site Marker, Model: Gmuc-17GGP | Senorx, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
| 2012 | 1 | 0 |
| 2015 | 2 | 2 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
2 devices in this family have a Class I recall. 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 FZP device
- #1 K260677 Vessel Closure Device (VCD177213P)score 12.6 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (11)
See all 112 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
What does this lineage say?
- Of its descendants, K113202 (Focal Therapeutics, 2012) has gone furthest, with 8 descendants of its own.
How does its category compare?
All FZP devicesFZP Clip, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FZP
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FZP
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FZP
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FZP
1,902in 2025
MAUDE reports naming product code FZP, 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 | 6 | 31 | 1 | 1,877 |
| 2008 | 4 | 23 | 6 | 981 |
| 2009 | 3 | 22 | 0 | 2,160 |
| 2010 | 6 | 47 | 1 | 2,367 |
| 2011 | 3 | 124 | 0 | 1,678 |
| 2012 | 2 | — | 1 | 1,677 |
| 2013 | 3 | 47 | 0 | 2,381 |
| 2014 | 3 | 29 | 1 | 2,320 |
| 2015 | 8 | 182 | 0 | 2,871 |
| 2016 | 5 | 72 | 2 | 1,840 |
| 2017 | 4 | 29 | 1 | 2,594 |
| 2018 | 4 | 143 | 0 | 2,718 |
| 2019 | 1 | — | 3 | 2,903 |
| 2020 | 2 | — | 1 | 1,760 |
| 2021 | 0 | — | 0 | 1,759 |
| 2022 | 3 | 227 | 0 | 1,575 |
| 2023 | 3 | 65 | 0 | 1,918 |
| 2024 | 2 | — | 0 | 2,067 |
| 2025 | 5 | 90 | 0 | 1,902 |
| 2026 | 2 | — | 0 | — |
https://510kreport.com/device/K011402 · printed Nov 6, 2026
Cite this page
510(k) Report. “K011402: 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/K011402
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026