510(k) · Cleared
ClearedLapBox Power Tissue Containment System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ark Surgical · PMU Containment System, Laparoscopic Power Morcellation, With Instrument Port
Cleared on Apr 15, 2025 as substantially equivalent to K192898 (Advanced Surgical Concepts, 2020) after an 81-day review. Its family tree reaches back 2 generations to 2016.
- Decided
- Apr 15, 2025
- Review
- 81 days
- Class
- Class II
- Product code
- PMU
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN150028 (2016). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 K192898 PneumoLinerscore 2.9 · 1 generation · 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 |
|---|---|---|---|
| * | K192898 | PneumoLinerSummary page 5…: 2 Review Panel: Obstetrics/Gynecology 2 PREDICATE DEVICE Primary Predicate: • PneumoLiner, manufactured by Advanced Surgical Concepts Ltd., K192898; Product Code: PMU. The predicate device has not been subject to a design-related recall. Reference device: x LapBox Tis… | 2020 |
| † | K221365 | LapBox Tissue Containment Removal System | 2022 |
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?
- The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 5.1 years on median.
- 1 of the 2 ancestors has a recall of any class.
- 1 other device also cites its predicate K192898.
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. 2025, 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 LapBox Power Tissue Containment System 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. The LapBox is compatible with electromechanical laparoscopic power morcellators that are between 15 mm…
Read the full statement (120 words)
The LapBox Power Tissue Containment System 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. The LapBox is compatible with 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. When used in women with fibroids, the LapBox Power Tissue Containment System is for women who are pre-menopausal and under age 50.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250212 · printed Nov 4, 2026
Cite this page
510(k) Report. “K250212: LapBox Power Tissue Containment System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K250212
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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