FDA product code OMT: Absorbable Lung Biopsy Plug
OMT is the FDA product code for absorbable lung biopsy plug. It is a Class II device, regulated under 21 CFR 878.4755 and reviewed by the Anesthesiology panel. FDA has cleared 1 510(k) submission under OMT, 1 in the last five years. The average 510(k) review took 126 days (median 126); 126 days on average over the last three years. 1 De Novo request was granted under it. FDA has posted 1 recall for OMT devices.
Definition
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.
Classification
| Field | Value |
|---|---|
| Device name | Absorbable Lung Biopsy Plug |
| Device class | Class II |
| Regulation | 21 CFR 878.4755 |
| Review panel | AN — Anesthesiology |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for OMT
| Year | Clearances | Avg. review days |
|---|---|---|
| 2025 | 1 | 126 |
Compare with all 510(k) review times · Search every OMT clearance
Top OMT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Selio Medical Limited | 1 | 2025-04-08 |
Most recent OMT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K243722 | Selio Medical Limited | 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) | 2025-04-08 | 126 |
Recalls for OMT devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2016-09-24.
Frequently asked questions
What is FDA product code OMT?
OMT is the FDA product code for absorbable lung biopsy plug. It is a Class II device, regulated under 21 CFR 878.4755 and reviewed by the Anesthesiology panel.
What device class is OMT?
Class II, regulation 21 CFR 878.4755. Typical premarket route: 510(k).
How long does a 510(k) take for product code OMT?
Across 1 cleared submissions the average was 126 days from receipt to decision (median 126).
Which companies have the most OMT clearances?
Selio Medical Limited (1).
Have OMT devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2016-09-24.
Next steps
- Run an FDA pathway report with predicate devices for product code OMT
- Run a recall and safety report across every OMT manufacturer
- Watch product code OMT for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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