510(k) Report

510(k) · Cleared

Cleared

Pre-B Seal Lung Biopsy Plug System - 15cm Model (FG0001); Pre-B Seal Lung Biopsy Plug System - 16cm Model (FG0002); Pre-B Seal Lung Biopsy Plug System - 20cm Model (FG0003)

K243722510(k) TraditionalCleared Apr 8, 2025126-day reviewClass II21 CFR 878.4755

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Selio Medical Limited · OMT Absorbable Lung Biopsy Plug

Cleared on Apr 8, 2025 as substantially equivalent to DEN090007 (Angiotech, 2012) after a 126-day review. Its family tree reaches back 1 generation to 2012.

Decided
Apr 8, 2025
Review
126 days
Class
Class II
Product code
OMT
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to DEN090007 (2012). No later device cites it as a predicate yet.

DEN090007 · Bio-Seal Lung Biopsy Tract System · Angiotech · 20122010201520202025
DEN090007 · Bio-Seal Lung Biopsy Tract System · Angiotech · 20120
  1. Root · 1 generation backDEN090007 Bio-Seal Lung Biopsy Tract SystemAngiotech · 2012
  2. This deviceK243722 Pre-B Seal Lung Biopsy Plug System - 15cm Model (FG0001); Pre-B Seal…Selio Medical Limited · 2025
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1DEN090007Bio-Seal Lung Biopsy Tract SystemAngiotech2012—
0 (this device)K243722Pre-B Seal Lung Biopsy Plug System - 15cm Model (FG0001); Pre-B Seal Lung…Selio Medical Limited2025—
FIG. 1 — Lineage of K243722, 2012–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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.

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  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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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.

TypeNumberDeviceApplicantDecidedRecalls
*DEN090007Bio-Seal Lung Biopsy Tract System
Summary page 6
…ication Panel: Anesthesiology Predicate Device: Primary Predicate Name and 510(k) Number: Bio-Seal Lung Biopsy Tract Plug System (DEN090007). This predicate has not been subject to a design-related recall. There are no reference devices identified in th…
Angiotech2012—

What descends from it?

No later submission names this one as a predicate yet.

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?

  • Its one ancestor has no recall.

How does its category compare?

All OMT devices

OMT Absorbable Lung Biopsy Plug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.

FDA decisions per year · OMT

1in 2025

2012: 12025: 1
2007high 1 (2012) · low 0 (2007)2026

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

2016: 1
2007high 1 (2016) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · OMT

3in 2025

2018: 12020: 12022: 12023: 12025: 3
2007high 3 (2025) · low 0 (2007)2025

MAUDE reports naming product code OMT, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20121—00
20130—00
20140—00
20150—00
20160—10
20170—00
20180—01
20190—00
20200—01
20210—00
20220—01
20230—01
20240—00
20251—03
20260—0—

What is it indicated for?

The Pre-B. Seal Lung Biopsy Plug System is indicated for sealing pleural punctures to reduce the risk of pneumothoraces (air leaks) associated with percutaneous, transthoracic needle lung biopsies and to provide accuracy in marking a biopsy needle entry site for visualization during surgical resection.

The Pre-B. Seal Lung Biopsy Plug System is indicated for use in adult patients (22 years of age and older).

Indications for use as stated in the FDA summary.

Recent decisions in OMT

The OMT category page

  • DEN090007Bio-Seal Lung Biopsy Tract SystemAngiotech · 2012

https://510kreport.com/device/K243722 · printed Nov 6, 2026

Cite this page

510(k) Report. “K243722: Pre-B Seal Lung Biopsy Plug System - 15cm Model (FG0001); Pre-B Seal Lung Biopsy Plug System - 16cm Model (FG0002); Pre-B Seal Lung Biopsy Plug System - 20cm Model (FG0003).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243722

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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