De Novo · Granted
GrantedPneumoLiner
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Surgical Concepts, Ltd. · PMU Containment System, Laparoscopic Power Morcellation, With Instrument Port
Granted on Apr 7, 2016 as a new device type through De Novo after a 293-day review. 3 later devices descend from it.
- Decided
- Apr 7, 2016
- Review
- 293 days
- Class
- Class II
- Product code
- PMU
- Recalls
- None
3 later devices descend from it, 1 citing it directly.
- This deviceDEN150028 PneumoLinerAdvanced Surgical Concepts, Ltd. · 2016
- Descendant · cites it directly · 2 of its ownK192898 PneumoLinerAdvanced Surgical Concepts · 2020 · Recalled
- Descendant · 2 generations on · 0 of its ownK250212 LapBox Power Tissue Containment SystemArk Surgical · 2025
- Descendant · 2 generations on · 0 of its ownK212659 More-Cell-SystemAgency For Medical Innovations GmbH · 2021
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN150028 | PneumoLiner | Advanced Surgical Concepts, Ltd. | 2016 | — |
| +1 | K192898 | PneumoLiner | Advanced Surgical Concepts | 2020 | 1 |
| +2 | K250212 | LapBox Power Tissue Containment System | Ark Surgical | 2025 | — |
| +2 | K212659 | More-Cell-System | Agency For Medical Innovations GmbH | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA De Novo 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.
Planning a device in PMU? 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 PMU device
- #1 K250212 LapBox Power Tissue Containment Systemscore 9.5 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K192898 | PneumoLiner | 2020 | 2 |
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, K192898 (Advanced Surgical Concepts, 2020) has gone furthest, with 2 descendants of its own.
How does its category compare?
All PMU devicesPMU Containment System, Laparoscopic Power Morcellation, With Instrument Port: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · PMU
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PMU
Too few PMU 510(k)s in any year since 2007 to give a median.
Recalls per year · PMU
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PMU
3in 2023
MAUDE reports naming product code PMU, 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 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 3 |
| 2020 | 1 | — | 0 | 1 |
| 2021 | 1 | — | 1 | 2 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Use as a multiple instrument port and tissue containment system during minimally invasive gynecologic laparoscopic surgery to enable the isolation and containment of tissue considered benign, resected during single-port or multi-site laparoscopic surgery during power morcellation and removal. The PneumoLiner is compatible with bipolar or electromechanical laparoscopic power morcellators that are between 15 mm and 18 mm in shaft outer diameter and 135 mm and 180 mm in shaft working length and which have an external component that allows for the proper orientation of the laparoscope to perform a contained morcellation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN150028 · printed Nov 5, 2026
Cite this page
510(k) Report. “DEN150028: PneumoLiner.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/DEN150028
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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