510(k) · Cleared
Recalled · Class I · 2024BioZorb LP 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 Aug 26, 2015 as substantially equivalent to K143484 (Focal Therapeutics, 2015) after a 30-day review. Its family tree reaches back 6 generations to 2001. 2 of the 19 devices in its family, counting itself, have a Class I recall. 5 later devices descend from it. It has been recalled 3 times, including 2 Class I recalls.
- Decided
- Aug 26, 2015
- Review
- 30 days
- Class
- Class II
- Product code
- NEU
- Recalls
- 3 (2 Class I)
- Predicates
- 1
Its longest line of descent runs back 6 generations to K001807 (2001). 13 ancestors in all. 5 later devices descend from it, 4 citing it directly. 2 of the 19 devices in this family, counting this one, have a Class I recall.
- Root · 6 generations backK001807 Tissue MarkerAdvanced Uroscience, Inc. · 2001
- 5 generations backK032347 Biomarc Tissue MarkerCarbon Medical Technologies, Inc. · 2003
- 4 generations backK042296 Biomarc Preloaded Tissue Marker DeviceCarbon Medical Technologies, Inc. · 2004
- 3 generations backK072913 Securmark Biopsy Site Identification SystemSuros Surgical Systems, Inc. A Hologic Company · 2008
- 2 generations backK113202 Tissue MarkerFocal Therapeutics · 2012
- 1 generation backK143484 BioZorb MarkerFocal Therapeutics · 2015 · Recalled (Class I)
- This deviceK152070 BioZorb LP MarkerFocal Therapeutics · 2015
- Descendant · cites it directly · 1 of its ownK180640 SmartClip Soft Tissue MarkerElucent Medical, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK233639 SmartClip Secure Soft Tissue MarkerElucent Medical, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK192371 BioZorb SP MarkerFocal Therapeutics · 2019
- Descendant · cites it directly · 0 of its ownK180621 EchoMark, EchoMark LPSonavex, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK171467 BioZorb Marker GOLD / LP Marker GOLDFocal Therapeutics · 2017
Class I recalls in this family
- K143484 BioZorb Markerdirect predicate · 2015
Most influential descendants
Showing 5 of 5 · See all- K180640SmartClip Soft Tissue MarkerElucent Medical, Inc. · 2018 · cites it directly1descendant
- K233639SmartClip Secure Soft Tissue MarkerElucent Medical, Inc. · 2024 · 2 generations on0descendants
- K192371BioZorb SP MarkerFocal Therapeutics · 2019 · cites it directly0descendants
- K180621EchoMark, EchoMark LPSonavex, Inc. · 2018 · cites it directly0descendants
- K171467BioZorb Marker GOLD / LP Marker GOLDFocal Therapeutics · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K001807 | Tissue Marker | Advanced Uroscience, Inc. | 2001 | — |
| −5 | K032347 | Biomarc Tissue Marker | Carbon Medical Technologies, Inc. | 2003 | — |
| −4 | K042296 | Biomarc Preloaded Tissue Marker Device | Carbon Medical Technologies, Inc. | 2004 | — |
| −3 | K072913 | Securmark Biopsy Site Identification System | Suros Surgical Systems, Inc. A Hologic Company | 2008 | — |
| −2 | K113202 | Tissue Marker | Focal Therapeutics | 2012 | — |
| −1 | K143484 | BioZorb Marker | Focal Therapeutics | 2015 | Class I |
| 0 (this device) | K152070 | BioZorb LP Marker | Focal Therapeutics | 2015 | — |
| +1 | K180640 | SmartClip Soft Tissue Marker | Elucent Medical, Inc. | 2018 | — |
| +2 | K233639 | SmartClip Secure Soft Tissue Marker | Elucent Medical, Inc. | 2024 | — |
| +1 | K192371 | BioZorb SP Marker | Focal Therapeutics | 2019 | — |
| +1 | K180621 | EchoMark, EchoMark LP | Sonavex, Inc. | 2018 | — |
| +1 | K171467 | BioZorb Marker GOLD / LP Marker GOLD | Focal Therapeutics | 2017 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 2 | 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 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 |
|---|---|---|---|
| * | K143484 | BioZorb MarkerSummary page 4…Clip, 21 CFR, 878.4300 NAME: DEVICE Class II CLASSIFICATION: PRODUCT CODE NEU PREDICATE DEVICES: (primary) BioZorb Marker (K143484) Substantially Equivalent To: The modified BioZorb Marker (BioZorb LP Marker) is substantially equivalent in intended use, princ… | 2015 |
What descends from it? (5)
4 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 10, 2024 | Class I | Z-0328-2025 | Device Design | Firm received reports of adverse events/complications that include serious injuries, such as pain, infection, rash, device migration, device erosion, seroma, and discomfort. |
| Mar 13, 2024 | Class I | Z-1733-2024 | Unknown/Undetermined by firm | Safety Information: Complaints describe complications/adverse events that include pain, infection, rash, device migration, device erosion, seroma, discomfort, or other complications from feeling the device in the breast, and the need for… |
| Aug 9, 2022 | Class II | Z-1858-2022 | Incorrect or no expiration date | Hologic BioZorb LP Marker, (Product number F0221), lot number 22A0RL, contained removable labels with an expiration date that indicated the product had already expired. The expiration date on the removable label is actually manufacturing… |
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.
- K143484BioZorb MarkerFocal Therapeutics · 2015 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 14 years and passes through 4 companies; a new generation was cleared every 3.3 years on median.
- 2 of the 13 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K180640 (Elucent Medical, Inc., 2018) has gone furthest, with 1 descendant of its own.
- 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. 2015, 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 LP 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/K152070 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152070: BioZorb LP Marker.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152070
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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