510(k) · Cleared
Recalled · Class II · 2021PneumoLiner
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Surgical Concepts · PMU Containment System, Laparoscopic Power Morcellation, With Instrument Port
Cleared on Feb 25, 2020 as substantially equivalent to DEN150028 (Advanced Surgical Concepts, Ltd., 2016) after a 137-day review. Its family tree reaches back 1 generation to 2016. 2 later devices descend from it. It has been recalled once.
- Decided
- Feb 25, 2020
- Review
- 137 days
- Class
- Class II
- Product code
- PMU
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN150028 (2016). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backDEN150028 PneumoLinerAdvanced Surgical Concepts, Ltd. · 2016
- This deviceK192898 PneumoLinerAdvanced Surgical Concepts · 2020
- Descendant · cites it directly · 0 of its ownK250212 LapBox Power Tissue Containment SystemArk Surgical · 2025
- Descendant · cites it directly · 0 of its ownK212659 More-Cell-SystemAgency For Medical Innovations GmbH · 2021
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN150028 | PneumoLiner | Advanced Surgical Concepts, Ltd. | 2016 | — |
| 0 (this device) | K192898 | PneumoLiner | Advanced Surgical Concepts | 2020 | — |
| +1 | K250212 | LapBox Power Tissue Containment System | Ark Surgical | 2025 | — |
| +1 | K212659 | More-Cell-System | Agency For Medical Innovations GmbH | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2025 | 1 | 0 |
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.
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
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN150028 | PneumoLinerSummary page 4…Laparoscopic Power Morcellation Containment System Regulatory Class: Class II Product Code: PMU Predicate Device Advanced Surgical Concepts Ltd. PneumoLiner DEN150028 Classification Name: Gynecologic Laparoscopic Power Morcellation Containment System Regulatory Class: Cl… | 2016 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 21, 2021 | Class II | Z-0176-2022 | Nonconforming Material/Component | Due to manufacturing error, the Pneumoliner Bag Distal Tab that exits the Introducer shaft is in the wrong orientation. This results in the user deploying the bag upside down, which will make tissue encapsulation and bag closure more… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K250212 (Ark Surgical, 2025) has gone furthest, with 0 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. 2020, 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?
The PneumoLiner device is intended 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. When used in women with fibroids, the PneumoLiner is for women who are pre-menopausal and under age 50. The PneumoLiner is…
Read the full statement (111 words)
The PneumoLiner device is intended 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. When used in women with fibroids, the PneumoLiner is for women who are pre-menopausal and under age 50. The PneumoLiner is compatible with bipolar or electromechanical laparoscopic power morcellators that are between 15mm and 18mm in shaft outer diameter and 135mm and 180mm 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/K192898 · printed Nov 5, 2026
Cite this page
510(k) Report. “K192898: PneumoLiner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K192898
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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