510(k) · Cleared
ClearedCaas II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pie Medical Equipment B.V. · IZI System, X-Ray, Angiographic
Cleared on Jun 28, 1995 after a 226-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 5 of the 46 devices in its family, counting itself, have a Class I recall. 45 later devices descend from it.
- Decided
- Jun 28, 1995
- Review
- 226 days
- Class
- Class II
- Product code
- IZI
- Recalls
- None
- Predicates
- 0
45 later devices descend from it, 2 citing it directly. 5 of the 46 devices in this family, counting this one, have a Class I recall.
- This deviceK945540 Caas IIPie Medical Equipment B.V. · 1995
- Descendant · cites it directly · 44 of its ownK012475 Caas II QvaPie Medical Imaging BV · 2001
- Descendant · cites it directly · 43 of its ownK052988 CAASPie Medical Imaging BV · 2005
- Descendant · 2 generations on · 39 of its ownK063344 Caas Qca 3DPie Medical Imaging BV · 2006
- Descendant · 3 generations on · 38 of its ownK072591 Cardiop-B System, Version 2.1Paieon, Inc. · 2007
- Descendant · 2 generations on · 37 of its ownK073328 Cardiop-B System, Version 2.1 with LvaPaieon, Inc. · 2008
Showing 5 of 45 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K190106 Intra-Operative Positioning System; Simple Curve…6 generations on · 2019
- K242133 Intra-Operative Positioning System (IOPS®)…7 generations on · 2024
- K241243 Intra-Operative Positioning System (IOPS®)…7 generations on · 2024
- K230309 Intra-Operative Positioning System (IOPS®)…7 generations on · 2023
Most influential descendants
Showing 5 of 45 · See all- K012475Caas II QvaPie Medical Imaging BV · 2001 · cites it directly44descendants
- K052988CAASPie Medical Imaging BV · 2005 · cites it directly43descendants
- K063344Caas Qca 3DPie Medical Imaging BV · 2006 · 2 generations on39descendants
- K072591Cardiop-B System, Version 2.1Paieon, Inc. · 2007 · 3 generations on38descendants
- K073328Cardiop-B System, Version 2.1 with LvaPaieon, Inc. · 2008 · 2 generations on37descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K945540 | Caas II | Pie Medical Equipment B.V. | 1995 | — |
| +1 | K012475 | Caas II Qva | Pie Medical Imaging BV | 2001 | — |
| +1 | K052988 | CAAS | Pie Medical Imaging BV | 2005 | — |
| +2 | K063344 | Caas Qca 3D | Pie Medical Imaging BV | 2006 | — |
| +3 | K072591 | Cardiop-B System, Version 2.1 | Paieon, Inc. | 2007 | — |
| +2 | K073328 | Cardiop-B System, Version 2.1 with Lva | Paieon, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 6 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 1 |
| 2021 | 1 | 0 |
| 2023 | 4 | 1 |
| 2024 | 3 | 2 |
| 2025 | 4 | 1 |
| 2026 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
5 devices in this family have a Class I recall. 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 IZI device
- #1 K230727 SPY Portable Handheld Imaging (SPY-PHI) Systemscore 23.2 · 20 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (45)
See all 452 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (5 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K190106Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter ; Angled Tip Guidewire…Centerline Biomedical, Inc. · 2019 · 6 generations on · ◆ in the 2019 descendants bar of FIG. 11 Class I recall
- K242133Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative Positioning System…Centerline Biomedical, Inc. · 2024 · 7 generations on · ◆ in the 2024 descendants bar of FIG. 11 Class I recall
- K241243Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters); Intra-Operative Positioning…Centerline Biomedical, Inc. · 2024 · 7 generations on · ◆ in the 2024 descendants bar of FIG. 11 Class I recall
- K230309Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter (SCC-1) and IOPS Reverse Curve…Centerline Biomedical, Inc. · 2023 · 7 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
- K243842Intra-Operative Positioning System (IOPS®)Centerline Biomedical, Inc. · 2025 · 7 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K012475 (Pie Medical Imaging BV, 2001) has gone furthest, with 44 descendants of its own.
How does its category compare?
All IZI devicesIZI System, X-Ray, Angiographic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IZI
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IZI
81in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IZI
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IZI
2,171in 2025
MAUDE reports naming product code IZI, 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 | 7 | 28 | 6 | 92 |
| 2008 | 6 | 68 | 52 | 101 |
| 2009 | 2 | — | 18 | 132 |
| 2010 | 2 | — | 11 | 252 |
| 2011 | 4 | 104 | 6 | 377 |
| 2012 | 1 | — | 6 | 77 |
| 2013 | 1 | — | 6 | 58 |
| 2014 | 4 | 111 | 5 | 123 |
| 2015 | 0 | — | 14 | 36 |
| 2016 | 1 | — | 7 | 102 |
| 2017 | 2 | — | 1 | 88 |
| 2018 | 2 | — | 2 | 49 |
| 2019 | 2 | — | 2 | 30 |
| 2020 | 1 | — | 2 | 14 |
| 2021 | 1 | — | 1 | 29 |
| 2022 | 1 | — | 0 | 265 |
| 2023 | 3 | 81 | 0 | 1,204 |
| 2024 | 2 | — | 0 | 1,332 |
| 2025 | 2 | — | 0 | 2,171 |
| 2026 | 2 | — | 1 | — |
https://510kreport.com/device/K945540 · printed Nov 5, 2026
Cite this page
510(k) Report. “K945540: Caas II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K945540
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026