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 May 4, 2020 as substantially equivalent to K182053 (Alesi Surgical, Ltd., 2018) after a 117-day review. Its family tree reaches back 3 generations to 2016. 3 later devices descend from it.
- Decided
- May 4, 2020
- Review
- 117 days
- Class
- Class II
- Product code
- PQM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to DEN150022 (2016). 3 later devices descend from it, 3 citing it directly.
- Root · 3 generations backDEN150022 Ultravision Visual Clearing SystemAlesi Surgical, Ltd. · 2016
- 2 generations backK170178 Ultravision Visual Field Clearing SystemAlesi Surgical, Ltd. · 2017
- 1 generation backK182053 Ultravision™ Visual Field Clearing SystemAlesi Surgical, Ltd. · 2018
- This deviceK200035 Ultravision Visual Field Clearing SystemAlesi Surgical, Ltd. · 2020
- Descendant · cites it directly · 1 of its ownK231298 Ultravision2™ System Integrated Monopolar L-Hook (H/S)™Alesi Surgical, Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK240868 Ultravision2™ IonPencilAlesi Surgical Limited · 2024
- Descendant · cites it directly · 0 of its ownK231238 Ultravision2™ SystemAlesi Surgical, Ltd. · 2023
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 |
|---|---|---|---|---|---|
| −3 | DEN150022 | Ultravision Visual Clearing System | Alesi Surgical, Ltd. | 2016 | — |
| −2 | K170178 | Ultravision Visual Field Clearing System | Alesi Surgical, Ltd. | 2017 | — |
| −1 | K182053 | Ultravision™ Visual Field Clearing System | Alesi Surgical, Ltd. | 2018 | — |
| 0 (this device) | K200035 | Ultravision Visual Field Clearing System | Alesi Surgical, Ltd. | 2020 | — |
| +1 | K231298 | Ultravision2™ System Integrated Monopolar L-Hook (H/S)™ | Alesi Surgical, Ltd. | 2023 | — |
| +1 | K240868 | Ultravision2™ IonPencil | Alesi Surgical Limited | 2024 | — |
| +1 | K231238 | Ultravision2™ System | Alesi Surgical, Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K182053 | Ultravision™ Visual Field Clearing SystemSummary page 4…21CFR 878.5050 Regulatory Class: Class II Product Code(s): PQM Predicate Device: Ultravision™ Visual Field Clearing System (K182053) Reference Devices: 1. Smoke Evacuator pencil system comprising of Valley Lab Button swi… | 2018 |
| † | K914400 | Models E2502B/E2525 Reusable Handswitching Pencils | 1991 |
| † | K000904 | Penadapt 10 | 2000 |
| † | K142335 | RapidVac Smoke Evacuator System | 2015 |
| † | K954869 | Medcare Yankauer Suction Device | 1996 |
What descends from it? (3)
3 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)
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 4 years and passes through 1 company; a new generation was cleared every 1.3 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K231298 (Alesi Surgical, Ltd., 2023) has gone furthest, with 1 descendant 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. 2020, 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 surgery, including laparoscopic surgery.
The Ultravision™ 5mm Trocar component establishes a path of entry for instruments used in laparoscopic surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200035 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200035: Ultravision Visual Field Clearing System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200035
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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