510(k) · Cleared
Cleared14G Cormark Biopsy Site Identifier
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Artemis Medical, Inc. · FZP Clip, Implantable
Cleared on Aug 21, 2003 after a 31-day review. The FDA summary names its predicate without a number. 2 of the 10 devices in its family, counting itself, have a Class I recall. 9 later devices descend from it.
- Decided
- Aug 21, 2003
- Review
- 31 days
- Class
- Class II
- Product code
- FZP
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 1 citing it directly. 2 of the 10 devices in this family, counting this one, have a Class I recall.
- This deviceK032217 14G Cormark Biopsy Site IdentifierArtemis Medical, Inc. · 2003
- 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 · 4 generations on · 0 of its ownK233639 SmartClip Secure Soft Tissue MarkerElucent Medical, Inc. · 2024
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 9 · 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
- K233639SmartClip Secure Soft Tissue MarkerElucent Medical, Inc. · 2024 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K032217 | 14G Cormark Biopsy Site Identifier | Artemis Medical, Inc. | 2003 | — |
| +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 | — |
| +4 | K233639 | SmartClip Secure Soft Tissue Marker | Elucent Medical, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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), 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.
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? (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 |
|---|---|---|---|
| * | — | Caris Site Marker Named without a submission number |
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K113202 | Tissue Marker | 2012 | 8 |
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 | — |
What is it indicated for?
The 14G CoRMARK™ Biopsy Site Identifier is intended for use during an open surgical or percutaneous breast biopsy procedure to mark the biopsy site.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032217 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032217: 14G Cormark Biopsy Site Identifier.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032217
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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