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 26, 2017 as substantially equivalent to DEN150022 (Alesi Surgical, Ltd., 2016) after a 127-day review. Its family tree reaches back 1 generation to 2016. 5 later devices descend from it.
- Decided
- May 26, 2017
- Review
- 127 days
- Class
- Class II
- Product code
- PQM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN150022 (2016). 5 later devices descend from it, 1 citing it directly.
- Root · 1 generation backDEN150022 Ultravision Visual Clearing SystemAlesi Surgical, Ltd. · 2016
- This deviceK170178 Ultravision Visual Field Clearing SystemAlesi Surgical, Ltd. · 2017
- Descendant · cites it directly · 4 of its ownK182053 Ultravision™ Visual Field Clearing SystemAlesi Surgical, Ltd. · 2018
- Descendant · 2 generations on · 3 of its ownK200035 Ultravision Visual Field Clearing SystemAlesi Surgical, Ltd. · 2020
- Descendant · 3 generations on · 1 of its ownK231298 Ultravision2™ System Integrated Monopolar L-Hook (H/S)™Alesi Surgical, Ltd. · 2023
- Descendant · 3 generations on · 0 of its ownK240868 Ultravision2™ IonPencilAlesi Surgical Limited · 2024
- Descendant · 3 generations on · 0 of its ownK231238 Ultravision2™ SystemAlesi Surgical, Ltd. · 2023
Most influential descendants
Showing 5 of 5 · See all- K182053Ultravision™ Visual Field Clearing SystemAlesi Surgical, Ltd. · 2018 · cites it directly4descendants
- K200035Ultravision Visual Field Clearing SystemAlesi Surgical, Ltd. · 2020 · 2 generations on3descendants
- K231298Ultravision2™ System Integrated Monopolar L-Hook (H/S)™Alesi Surgical, Ltd. · 2023 · 3 generations on1descendant
- K240868Ultravision2™ IonPencilAlesi Surgical Limited · 2024 · 3 generations on0descendants
- K231238Ultravision2™ SystemAlesi Surgical, Ltd. · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN150022 | Ultravision Visual Clearing System | Alesi Surgical, Ltd. | 2016 | — |
| 0 (this device) | K170178 | Ultravision Visual Field Clearing System | Alesi Surgical, Ltd. | 2017 | — |
| +1 | K182053 | Ultravision™ Visual Field Clearing System | Alesi Surgical, Ltd. | 2018 | — |
| +2 | K200035 | Ultravision Visual Field Clearing System | Alesi Surgical, Ltd. | 2020 | — |
| +3 | K231298 | Ultravision2™ System Integrated Monopolar L-Hook (H/S)™ | Alesi Surgical, Ltd. | 2023 | — |
| +3 | K240868 | Ultravision2™ IonPencil | Alesi Surgical Limited | 2024 | — |
| +3 | K231238 | Ultravision2™ System | Alesi Surgical, Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | DEN150022 | Ultravision Visual Clearing SystemSummary page 5…Class II Product Code(s): PQM Regulation Number(s): 878.5050 Predicate Devices: Ultravision™ Visual Field Clearing System DEN150022 Intended Use: The Ultravision™ Visual Field Clearing System is indicated for… | 2016 |
| † | K032676 | Endopath Bladeless Trocar, Endopath Blunt Tip Trocar, Endopath Dilating Tip Trocar | 2003 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K182053 | Ultravision™ Visual Field Clearing System | 2018 | 4 |
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?
- Its one ancestor has no recall.
- Of its descendants, K182053 (Alesi Surgical, Ltd., 2018) has gone furthest, with 4 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. 2017, 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 5mm Trocar component also establishes a path of entry for instruments used in laparoscopic surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170178 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170178: 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/K170178
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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