510(k) · Cleared
ClearedBioZorb SP Marker
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Focal Therapeutics · NEU Marker, Radiographic, Implantable
Cleared on Sep 26, 2019 as substantially equivalent to K143484 (Focal Therapeutics, 2015) and 1 other predicate after a 27-day review. Its family tree reaches back 7 generations to 2001. 2 of the 15 devices in its family, counting itself, have a Class I recall.
- Decided
- Sep 26, 2019
- Review
- 27 days
- Class
- Class II
- Product code
- NEU
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K001807 (2001). 14 ancestors in all. No later device cites it as a predicate yet. 2 of the 15 devices in this family, counting this one, have a Class I recall.
- Root · 7 generations backK001807 Tissue MarkerAdvanced Uroscience, Inc. · 2001
- 6 generations backK032347 Biomarc Tissue MarkerCarbon Medical Technologies, Inc. · 2003
- 5 generations backK042296 Biomarc Preloaded Tissue Marker DeviceCarbon Medical Technologies, Inc. · 2004
- 4 generations backK072913 Securmark Biopsy Site Identification SystemSuros Surgical Systems, Inc. A Hologic Company · 2008
- 3 generations backK113202 Tissue MarkerFocal Therapeutics · 2012
- 2 generations backK143484 BioZorb MarkerFocal Therapeutics · 2015 · Recalled (Class I)
- 1 generation backK152070 BioZorb LP MarkerFocal Therapeutics · 2015 · Recalled (Class I)
- This deviceK192371 BioZorb SP MarkerFocal Therapeutics · 2019
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K001807 | Tissue Marker | Advanced Uroscience, Inc. | 2001 | — |
| −6 | K032347 | Biomarc Tissue Marker | Carbon Medical Technologies, Inc. | 2003 | — |
| −5 | K042296 | Biomarc Preloaded Tissue Marker Device | Carbon Medical Technologies, Inc. | 2004 | — |
| −4 | K072913 | Securmark Biopsy Site Identification System | Suros Surgical Systems, Inc. A Hologic Company | 2008 | — |
| −3 | K113202 | Tissue Marker | Focal Therapeutics | 2012 | — |
| −2 | K143484 | BioZorb Marker | Focal Therapeutics | 2015 | Class I |
| −1 | K152070 | BioZorb LP Marker | Focal Therapeutics | 2015 | Class I |
| 0 (this device) | K192371 | BioZorb SP Marker | Focal Therapeutics | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2007 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 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 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? (2)
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 |
|---|---|---|---|
| * | K143484 | BioZorb MarkerSummary page 4…Product Code: NEU Classification: Class II Panel: General and Plastic Surgery III. PREDICATE DEVICE BioZorb Marker (K143484) BioZorb LP Marker (K152070) These cleared products have not been subject to a design-related recall.… | 2015 |
| * | K152070 | BioZorb LP MarkerSummary page 4…lassification: Class II Panel: General and Plastic Surgery III. PREDICATE DEVICE BioZorb Marker (K143484) BioZorb LP Marker (K152070) These cleared products have not been subject to a design-related recall. IV. DEVICE DESCRIPTION… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 18 years and passes through 4 companies; a new generation was cleared every 3.3 years on median.
- 3 of the 14 ancestors have a recall of any class; 2 have a Class I recall.
- 4 other devices also cite its predicate K143484.
How does its category compare?
All NEU devicesNEU Marker, Radiographic, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 BioZorb SP Marker is indicated for radiographic marking of sites in soft tissue. In addition, the Marker is indicated in situations where the soft tissue site needs to be marked for future medical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192371 · printed Nov 4, 2026
Cite this page
510(k) Report. “K192371: BioZorb SP Marker.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K192371
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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