510(k) · Cleared
ClearedUltravision™ Visual Field 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
Cleared on Sep 7, 2018 as substantially equivalent to K170178 (Alesi Surgical, Ltd., 2017) after a 38-day review. Its family tree reaches back 2 generations to 2016. 4 later devices descend from it.
- Decided
- Sep 7, 2018
- Review
- 38 days
- Class
- Class II
- Product code
- PQM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN150022 (2016). 4 later devices descend from it, 1 citing it directly.
- Root · 2 generations backDEN150022 Ultravision Visual Clearing SystemAlesi Surgical, Ltd. · 2016
- 1 generation backK170178 Ultravision Visual Field Clearing SystemAlesi Surgical, Ltd. · 2017
- This deviceK182053 Ultravision™ Visual Field Clearing SystemAlesi Surgical, Ltd. · 2018
- Descendant · cites it directly · 3 of its ownK200035 Ultravision Visual Field Clearing SystemAlesi Surgical, Ltd. · 2020
- Descendant · 2 generations on · 1 of its ownK231298 Ultravision2™ System Integrated Monopolar L-Hook (H/S)™Alesi Surgical, Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK240868 Ultravision2™ IonPencilAlesi Surgical Limited · 2024
- Descendant · 2 generations on · 0 of its ownK231238 Ultravision2™ SystemAlesi Surgical, Ltd. · 2023
Most influential descendants
Showing 4 of 4 · See all- K200035Ultravision Visual Field Clearing SystemAlesi Surgical, Ltd. · 2020 · cites it directly3descendants
- K231298Ultravision2™ System Integrated Monopolar L-Hook (H/S)™Alesi Surgical, Ltd. · 2023 · 2 generations on1descendant
- K240868Ultravision2™ IonPencilAlesi Surgical Limited · 2024 · 2 generations on0descendants
- K231238Ultravision2™ SystemAlesi Surgical, Ltd. · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | DEN150022 | Ultravision Visual Clearing System | Alesi Surgical, Ltd. | 2016 | — |
| −1 | K170178 | Ultravision Visual Field Clearing System | Alesi Surgical, Ltd. | 2017 | — |
| 0 (this device) | K182053 | Ultravision™ Visual Field Clearing System | Alesi Surgical, Ltd. | 2018 | — |
| +1 | K200035 | Ultravision Visual Field Clearing System | Alesi Surgical, Ltd. | 2020 | — |
| +2 | K231298 | Ultravision2™ System Integrated Monopolar L-Hook (H/S)™ | Alesi Surgical, Ltd. | 2023 | — |
| +2 | K240868 | Ultravision2™ IonPencil | Alesi Surgical Limited | 2024 | — |
| +2 | K231238 | Ultravision2™ System | Alesi Surgical, Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 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 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
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 |
|---|---|---|---|
| * | K170178 | Ultravision Visual Field Clearing SystemSummary page 4…Regulation Number(s): 878.5050 Common Name: Surgical Smoke Precipitator Predicate Devices: Ultravision™ Visual Field Clearing System, K170178 Intended Use: The Ultravision™ Visual Field Clearing System is indicated for the cl… | 2017 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200035 | Ultravision Visual Field Clearing System | 2020 | 3 |
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 2 years and passes through 1 company; a new generation was cleared every 1.3 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K200035 (Alesi Surgical, Ltd., 2020) has gone furthest, with 3 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. 2018, 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?
The Ultravision™ Visual Field Clearing System is indicated for the clearance of smoke and other particulate matter that is created during laparoscopic surgery.
The Ultravision™ 5Smm Trocar establishes a path of entry for instruments used in laparoscopic surgery and includes the Ionwand for the clearance of smoke and other particulate matter that is created during laparoscopic surgery.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K182053 · printed Nov 5, 2026
Cite this page
510(k) Report. “K182053: Ultravision™ Visual Field Clearing System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K182053
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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