De Novo · Granted
GrantedBio-Seal Lung Biopsy Tract System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Angiotech · OMT Absorbable Lung Biopsy Plug
Granted on Dec 19, 2012 as a new device type through De Novo after a 1,342-day review. 1 later device descends from it.
- Decided
- Dec 19, 2012
- Review
- 1,342 days
- Class
- Class II
- Product code
- OMT
- Recalls
- None
1 later device descends from it, 1 citing it directly.
- This deviceDEN090007 Bio-Seal Lung Biopsy Tract SystemAngiotech · 2012
- Descendant · cites it directly · 0 of its ownK243722 Pre-B Seal Lung Biopsy Plug System - 15cm Model (FG0001); Pre-B Seal…Selio Medical Limited · 2025
Most influential descendants
Showing 1 of 1 · See all- K243722Pre-B Seal Lung Biopsy Plug System - 15cm Model (FG0001); Pre-B Seal Lung Biopsy Plug…Selio Medical Limited · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN090007 | Bio-Seal Lung Biopsy Tract System | Angiotech | 2012 | — |
| +1 | K243722 | Pre-B Seal Lung Biopsy Plug System - 15cm Model (FG0001); Pre-B Seal Lung… | Selio Medical Limited | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
Sources: FDA De Novo database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OMT? 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 OMT device
- #1 K243722 Pre-B Seal Lung Biopsy Plug System - 15cm…score 9.1 · 1 generation · no Class I recall
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K243722 | Pre-B Seal Lung Biopsy Plug System - 15cm Model (FG0001); Pre-B Seal Lung Biopsy Plug… | 2025 | 0 |
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?
- Of its descendants, K243722 (Selio Medical Limited, 2025) has gone furthest, with 0 descendants of its own.
How does its category compare?
All OMT devicesOMT Absorbable Lung Biopsy Plug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · OMT
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OMT
Too few OMT 510(k)s in any year since 2007 to give a median.
Recalls per year · OMT
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OMT
3in 2025
MAUDE reports naming product code OMT, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 1 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/DEN090007 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN090007: Bio-Seal Lung Biopsy Tract System.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN090007
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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