De Novo · Granted
GrantedUltravision Visual Clearing System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alesi Surgical, Ltd. · PQM Surgical Smoke Precipitator
Granted on Dec 20, 2016 as a new device type through De Novo after a 574-day review. 6 later devices descend from it.
- Decided
- Dec 20, 2016
- Review
- 574 days
- Class
- Class II
- Product code
- PQM
- Recalls
- None
6 later devices descend from it, 1 citing it directly.
- This deviceDEN150022 Ultravision Visual Clearing SystemAlesi Surgical, Ltd. · 2016
- Descendant · cites it directly · 5 of its ownK170178 Ultravision Visual Field Clearing SystemAlesi Surgical, Ltd. · 2017
- Descendant · 2 generations on · 4 of its ownK182053 Ultravision™ Visual Field Clearing SystemAlesi Surgical, Ltd. · 2018
- Descendant · 3 generations on · 3 of its ownK200035 Ultravision Visual Field Clearing SystemAlesi Surgical, Ltd. · 2020
- Descendant · 4 generations on · 1 of its ownK231298 Ultravision2™ System Integrated Monopolar L-Hook (H/S)™Alesi Surgical, Ltd. · 2023
- Descendant · 4 generations on · 0 of its ownK240868 Ultravision2™ IonPencilAlesi Surgical Limited · 2024
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K170178Ultravision Visual Field Clearing SystemAlesi Surgical, Ltd. · 2017 · cites it directly5descendants
- K182053Ultravision™ Visual Field Clearing SystemAlesi Surgical, Ltd. · 2018 · 2 generations on4descendants
- K200035Ultravision Visual Field Clearing SystemAlesi Surgical, Ltd. · 2020 · 3 generations on3descendants
- K231298Ultravision2™ System Integrated Monopolar L-Hook (H/S)™Alesi Surgical, Ltd. · 2023 · 4 generations on1descendant
- K240868Ultravision2™ IonPencilAlesi Surgical Limited · 2024 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN150022 | Ultravision Visual Clearing System | Alesi Surgical, Ltd. | 2016 | — |
| +1 | K170178 | Ultravision Visual Field Clearing System | Alesi Surgical, Ltd. | 2017 | — |
| +2 | K182053 | Ultravision™ Visual Field Clearing System | Alesi Surgical, Ltd. | 2018 | — |
| +3 | K200035 | Ultravision Visual Field Clearing System | Alesi Surgical, Ltd. | 2020 | — |
| +4 | K231298 | Ultravision2™ System Integrated Monopolar L-Hook (H/S)™ | Alesi Surgical, Ltd. | 2023 | — |
| +4 | K240868 | Ultravision2™ IonPencil | Alesi Surgical Limited | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 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 PQM? 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 PQM device
- #1 K231298 Ultravision2™ System Integrated Monopolar…score 10.2 · 4 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? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170178 | Ultravision Visual Field Clearing System | 2017 | 5 |
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, K170178 (Alesi Surgical, Ltd., 2017) has gone furthest, with 5 descendants of its own.
How does its category compare?
All PQM devicesPQM Surgical Smoke Precipitator: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · PQM
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · PQM
Too few PQM 510(k)s in any year since 2007 to give a median.
Recalls per year · PQM
No recall names PQM since 2007.
Adverse event reports per year · PQM
4in 2018
MAUDE reports naming product code PQM, 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 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 4 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
indicated for the clearance of smoke and other particulate matter that is created during laparoscopic surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN150022 · printed Nov 4, 2026
Cite this page
510(k) Report. “DEN150022: Ultravision Visual Clearing System.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/DEN150022
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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