510(k) · Cleared
ClearedUltravision2™ System Integrated Monopolar L-Hook (H/S)™
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) and 2 other predicates after a 180-day review. Its family tree reaches back 4 generations to 2016. 1 later device descends from it.
- Decided
- Oct 31, 2023
- Review
- 180 days
- Class
- Class II
- Product code
- PQM
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to DEN150022 (2016). 8 ancestors in all, the oldest K904560 (1990). 1 later device descends from it, 1 citing it directly.
- 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 deviceK231298 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
Most influential descendants
Showing 1 of 1 · See all- K240868Ultravision2™ IonPencilAlesi Surgical Limited · 2024 · cites it directly0descendants
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) | K231298 | Ultravision2™ System Integrated Monopolar L-Hook (H/S)™ | Alesi Surgical, Ltd. | 2023 | — |
| +1 | K240868 | Ultravision2™ IonPencil | Alesi Surgical Limited | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1996 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 K240868 Ultravision2™ IonPencilscore 9.0 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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…ulation: 21 CFR 878.4400 Product Code: GEI Regulatory Class: Class II Predicate Device: Ultravision™ Visual Field Clearing System (K200035) Covidien Laparoscopic Handset K964175 and Clean Coat™ Laparoscopic Wir… | 2020 |
| * | K964175 | Valleylab E2750 Laparoscopic Handset, Valleylab E2770 Series ElectrodesSummary page 5…ry Class: Class II Predicate Device: Ultravision™ Visual Field Clearing System (K200035) Covidien Laparoscopic Handset K964175 and Clean Coat™ Laparoscopic Wire L-Hook Monopolar Electrode K153265 (e… | 1996 |
| * | K153265 | New Deantronics Disposable Laparoscopic Electrodes, non-coated, and coatedSummary page 5…Covidien Laparoscopic Handset K964175 and Clean Coat™ Laparoscopic Wire L-Hook Monopolar Electrode K153265 (electrode) Page 1 of 8 Indications for Use: The Ultravision 2™ Integrated Monopolar L-Hook (H/S)™ is intende… | 2016 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K240868 | Ultravision2™ IonPencil | 2024 | 0 |
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.
- 2 of the 8 ancestors have a recall of any class.
- Of its descendants, K240868 (Alesi Surgical Limited, 2024) has gone furthest, with 0 descendants of its own.
- 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 Ultravision 2™ Integrated Monopolar L-Hook (H/S)™ is intended to be used with applications in surgical procedures to facilitate cutting, coagulating of tissue, in combination with 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/K231298 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231298: Ultravision2™ System Integrated Monopolar L-Hook (H/S)™.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231298
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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