510(k) · Cleared
ClearedUltravision2™ 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 Oct 31, 2023 as substantially equivalent to K200035 (Alesi Surgical, Ltd., 2020) after a 186-day review. Its family tree reaches back 4 generations to 2016.
- Decided
- Oct 31, 2023
- Review
- 186 days
- Class
- Class II
- Product code
- PQM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to DEN150022 (2016). No later device cites it as a predicate yet.
- Root · 4 generations backDEN150022 Ultravision Visual Clearing SystemAlesi Surgical, Ltd. · 2016
- 3 generations backK170178 Ultravision Visual Field Clearing SystemAlesi Surgical, Ltd. · 2017
- 2 generations backK182053 Ultravision™ Visual Field Clearing SystemAlesi Surgical, Ltd. · 2018
- 1 generation backK200035 Ultravision Visual Field Clearing SystemAlesi Surgical, Ltd. · 2020
- This deviceK231238 Ultravision2™ SystemAlesi Surgical, Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | DEN150022 | Ultravision Visual Clearing System | Alesi Surgical, Ltd. | 2016 | — |
| −3 | K170178 | Ultravision Visual Field Clearing System | Alesi Surgical, Ltd. | 2017 | — |
| −2 | K182053 | Ultravision™ Visual Field Clearing System | Alesi Surgical, Ltd. | 2018 | — |
| −1 | K200035 | Ultravision Visual Field Clearing System | Alesi Surgical, Ltd. | 2020 | — |
| 0 (this device) | K231238 | Ultravision2™ System | Alesi Surgical, Ltd. | 2023 | — |
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 |
|---|---|---|---|
| * | K200035 | Ultravision Visual Field Clearing SystemSummary page 5…ication Regulation: 21 CFR 878.5050 Regulatory Class: Class II Product Code(s): PQM Predicate Device: Ultravision™ Visual Field Clearing System (K200035) Page 1 of 6 Indications for Use: The Ultravision2™ System is indicated for the clearance of smoke and other… | 2020 |
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 7 years and passes through 1 company; a new generation was cleared every 1.7 years on median.
- None of the 4 ancestors has a recall.
- 2 other devices also cite its predicate K200035.
How does its category compare?
All PQM devicesPQM Surgical Smoke Precipitator: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 Ultravision2™ System is indicated for the clearance of smoke and other particulate matter that is created during laparoscopic surgery.
The Ultravision2™ 5mm Trocar component establishes a path of entry for instruments used in laparoscopic surgery.
The Ultravision2™ Generator interfaces directly with the electrosurgical generator and serves as a pass-through for RF energy to RF electrosurgical instruments.
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/K231238 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231238: Ultravision2™ System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231238
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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