510(k) · Cleared
ClearedFlurospot H Version 2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · JAA System, X-Ray, Fluoroscopic, Image-Intensified
Cleared on Nov 19, 1991 after a 40-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- Nov 19, 1991
- Review
- 40 days
- Class
- Class II
- Product code
- JAA
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 3 citing it directly.
- This deviceK914525 Flurospot H Version 2Siemens Medical Solutions USA, Inc. · 1991
- Descendant · cites it directly · 1 of its ownK961871 Flourospot T.O.P.Siemens Medical Solutions USA, Inc. · 1996
- Descendant · cites it directly · 1 of its ownK954159 Digital Imaging SystemCamtronics, Ltd. · 1996
- Descendant · 2 generations on · 0 of its ownK023467 HCP Dicom NetSoftlink International, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK982028 Fluorospot CompactSiemens Medical Solutions USA, Inc. · 1998
Most influential descendants
Showing 4 of 4 · See all- K961871Flourospot T.O.P.Siemens Medical Solutions USA, Inc. · 1996 · cites it directly1descendant
- K954159Digital Imaging SystemCamtronics, Ltd. · 1996 · cites it directly1descendant
- K023467HCP Dicom NetSoftlink International, Inc. · 2003 · 2 generations on0descendants
- K982028Fluorospot CompactSiemens Medical Solutions USA, Inc. · 1998 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K914525 | Flurospot H Version 2 | Siemens Medical Solutions USA, Inc. | 1991 | — |
| +1 | K961871 | Flourospot T.O.P. | Siemens Medical Solutions USA, Inc. | 1996 | — |
| +1 | K954159 | Digital Imaging System | Camtronics, Ltd. | 1996 | — |
| +2 | K023467 | HCP Dicom Net | Softlink International, Inc. | 2003 | — |
| +1 | K982028 | Fluorospot Compact | Siemens Medical Solutions USA, Inc. | 1998 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 2003 | 1 | 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.
Planning a device in JAA? 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 JAA device
- #1 K253103 Nexus DRF Digital X-ray Imaging Systemscore 13.2 · 7 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (4)
3 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?
- Of its descendants, K961871 (Siemens Medical Solutions USA, Inc., 1996) has gone furthest, with 1 descendant of its own.
How does its category compare?
All JAA devicesJAA System, X-Ray, Fluoroscopic, Image-Intensified: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JAA
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JAA
89in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JAA
4in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JAA
33in 2025
MAUDE reports naming product code JAA, 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 | — | 35 | 9,517 |
| 2008 | 6 | 18 | 21 | 9,484 |
| 2009 | 0 | — | 18 | 12,040 |
| 2010 | 1 | — | 6 | 5,803 |
| 2011 | 4 | 48 | 7 | 14,000 |
| 2012 | 1 | — | 2 | 11,684 |
| 2013 | 6 | 129 | 3 | 13,706 |
| 2014 | 6 | 276 | 1 | 10,265 |
| 2015 | 3 | 197 | 1 | 2,922 |
| 2016 | 2 | — | 7 | 35 |
| 2017 | 1 | — | 3 | 56 |
| 2018 | 3 | 30 | 1 | 36 |
| 2019 | 6 | 49 | 2 | 49 |
| 2020 | 4 | 39 | 2 | 39 |
| 2021 | 6 | 104 | 2 | 35 |
| 2022 | 1 | — | 5 | 34 |
| 2023 | 2 | — | 9 | 41 |
| 2024 | 3 | 89 | 2 | 25 |
| 2025 | 2 | — | 4 | 33 |
| 2026 | 1 | — | 0 | — |
https://510kreport.com/device/K914525 · printed Nov 6, 2026
Cite this page
510(k) Report. “K914525: Flurospot H Version 2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K914525
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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