510(k) · Cleared
Recalled · Class II · 2026Trinias
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shimadzu Corporation Medical Systems · OWB Interventional Fluoroscopic X-Ray System
Cleared on Apr 28, 2021 as substantially equivalent to K123508 (Shimadzu Corporation, 2014) after a 146-day review. Its family tree reaches back 1 generation to 2014. 2 later devices descend from it. It has been recalled once.
- Decided
- Apr 28, 2021
- Review
- 146 days
- Class
- Class II
- Product code
- OWB
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K123508 (2014). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK123508 TriniasShimadzu Corporation · 2014 · Recalled
- This deviceK203535 TriniasShimadzu Corporation Medical Systems · 2021
- Descendant · cites it directly · 1 of its ownK221922 TriniasShimadzu Corporation Medical Systems Division · 2022 · Recalled
- Descendant · 2 generations on · 0 of its ownK252099 TriniasShimadzu Corporation · 2026
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 | K123508 | Trinias | Shimadzu Corporation | 2014 | 8 |
| 0 (this device) | K203535 | Trinias | Shimadzu Corporation Medical Systems | 2021 | — |
| +1 | K221922 | Trinias | Shimadzu Corporation Medical Systems Division | 2022 | 1 |
| +2 | K252099 | Trinias | Shimadzu Corporation | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2026 | 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 OWB? 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 OWB device
- #1 K251602 Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6…score 18.3 · 18 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 |
|---|---|---|---|
| * | K123508 | TriniasSummary page 4…roscopic X-Ray System Regulatory Class: 11 Product Code: OWB Common/Usual Name: Interventional Fluoroscopic X-Ray System 2. Equivalent legally marketed device: K123508 Trade/Device Name: Trinias Manufacturer: Shimadzu. Regulation Number: 21CFR892.1650 Regulation Name: Interventional F… | 2014 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K221922 | Trinias | 2022 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 20, 2026 | Class II | Z-2294-2026 | Component design/selection | Electromagnetic contactors within high voltage generator may weld together, resulting in current being supplied to power supply even if power is off. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- Of its descendants, K221922 (Shimadzu Corporation Medical Systems Division, 2022) has gone furthest, with 1 descendant of its own.
How does its category compare?
All OWB devicesOWB Interventional Fluoroscopic X-Ray System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · OWB
22in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OWB
148in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OWB
42so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OWB
14,008in 2025
MAUDE reports naming product code OWB, 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 | 3 | 52 | 0 | 1 |
| 2008 | 4 | 135 | 1 | 0 |
| 2009 | 9 | 99 | 0 | 0 |
| 2010 | 7 | 66 | 0 | 0 |
| 2011 | 6 | 79 | 0 | 1 |
| 2012 | 6 | 37 | 0 | 1 |
| 2013 | 11 | 119 | 10 | 27 |
| 2014 | 15 | 158 | 9 | 103 |
| 2015 | 11 | 66 | 35 | 2,134 |
| 2016 | 16 | 103 | 13 | 4,074 |
| 2017 | 20 | 76 | 13 | 1,604 |
| 2018 | 23 | 54 | 6 | 1,449 |
| 2019 | 9 | 174 | 7 | 1,558 |
| 2020 | 16 | 53 | 8 | 1,581 |
| 2021 | 24 | 60 | 31 | 1,981 |
| 2022 | 21 | 90 | 24 | 2,932 |
| 2023 | 12 | 152 | 22 | 7,604 |
| 2024 | 13 | 126 | 11 | 7,942 |
| 2025 | 22 | 148 | 30 | 14,008 |
| 2026 | 15 | 221 | 42 | — |
What is it indicated for?
The Trinias is an angiographic X-ray system, which is used for diagnostic imaging and interventional procedures. The Trinias is intended to be used for cardiac angiography, neurovascular angiography, abdominal angiography, peripheral angiography, rotational angiography, multi-purpose angiography and whole body radiographic/fluoroscopic procedures
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203535 · printed Nov 4, 2026
Cite this page
510(k) Report. “K203535: Trinias.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K203535
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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