FDA product code · Anesthesiology

Absorbable Lung Biopsy Plug

Name: FDA decisions, review times, recalls and adverse event reports for product code OMT
Creator: 510(k) Report

OMTClass II21 CFR 878.4755510(k) required2 decisions since 20121 recall

2 FDA decisions since 2012. 510(k) reviews decided 2021–2025 took a median of 126 days (half between 126 and 126). 1 recall names this code; it is not Class I. The most-cited predicate is DEN090007, named by 1 later device.

A pre-formed (polymerized) absorbable lung biopsy plug is intended to provide accuracy in marking a biopsy location for visualization during surgical resection and closure of pleural punctures associated with percutaneous, transthoracic needle lung biopsies. Upon, deployment into the biopsy tract, the plug expands to fill the biopsy void and remains in place until resorbed.

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

FIG. A — Illustration, anesthesiology panel

Twenty years of OMT at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · OMT

1in 2025

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

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

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

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	—

FIG. 1 — OMT by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in OMT? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Absorbable Lung Biopsy Plug

Which predicates do OMT devices cite most?

Which OMT devices have the deepest lineage?

What has FDA decided in OMT lately?

What has been recalled in OMT lately?