510(k) · Cleared
ClearedStarion Universal Power Supply (Ups)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Starion Instruments · HQO Unit, Cautery, Thermal, Ac-Powered
Cleared on Dec 9, 2004 as substantially equivalent to K000893 (Starion Instruments, 2000) after a 24-day review. Its family tree reaches back 1 generation to 2000. 2 later devices descend from it.
- Decided
- Dec 9, 2004
- Review
- 24 days
- Class
- Class II
- Product code
- HQO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K000893 (2000). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK000893 AC Powered Thermal Cautery UnitStarion Instruments · 2000
- This deviceK043155 Starion Universal Power Supply (Ups)Starion Instruments · 2004
- Descendant · cites it directly · 0 of its ownK243918 Vasoview Hemopro 3 Power SupplyMaquet Cardiovascular, LLC · 2025
- Descendant · cites it directly · 0 of its ownK070871 Starion Universal Power SupplyStarion Instruments · 2007
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K000893 | AC Powered Thermal Cautery Unit | Starion Instruments | 2000 | — |
| 0 (this device) | K043155 | Starion Universal Power Supply (Ups) | Starion Instruments | 2004 | — |
| +1 | K243918 | Vasoview Hemopro 3 Power Supply | Maquet Cardiovascular, LLC | 2025 | — |
| +1 | K070871 | Starion Universal Power Supply | Starion Instruments | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2025 | 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 HQO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K000893 | AC Powered Thermal Cautery UnitSummary page 1…output, and principles of operation to the Starion Instruments Surgical Power Supply, a legally marketed predicate device which has been granted marketing clearance via K000893. The Starion Instruments Universal Power Supply (UPS) features an on/off switch, green power-on LED indicator, outlet(s)… | 2000 |
What descends from it? (2)
2 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?
- Its one ancestor has no recall.
- Of its descendants, K243918 (Maquet Cardiovascular, LLC, 2025) has gone furthest, with 0 descendants of its own.
How does its category compare?
All HQO devicesHQO Unit, Cautery, Thermal, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HQO
1in 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · HQO
Too few HQO 510(k)s in any year since 2007 to give a median.
Recalls per year · HQO
No recall names HQO since 2007.
Adverse event reports per year · HQO
101in 2025
MAUDE reports naming product code HQO, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 13 |
| 2011 | 0 | — | 0 | 30 |
| 2012 | 0 | — | 0 | 29 |
| 2013 | 0 | — | 0 | 40 |
| 2014 | 0 | — | 0 | 55 |
| 2015 | 0 | — | 0 | 42 |
| 2016 | 0 | — | 0 | 56 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 17 |
| 2019 | 0 | — | 0 | 73 |
| 2020 | 0 | — | 0 | 44 |
| 2021 | 0 | — | 0 | 56 |
| 2022 | 0 | — | 0 | 53 |
| 2023 | 0 | — | 0 | 48 |
| 2024 | 0 | — | 0 | 66 |
| 2025 | 0 | — | 0 | 101 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
For the simultaneous cutting and cauterization of soft tissue during surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043155 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043155: Starion Universal Power Supply (Ups).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043155
Report an extraction error
Are you the manufacturer?
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