510(k) · Cleared
ClearedNeuropet
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Photodetection Systems, Inc. · KPS System, Tomography, Computed, Emission
Cleared on May 8, 2009 after an 8-day review. The FDA summary names its predicate without a number. 5 later devices descend from it.
- Decided
- May 8, 2009
- Review
- 8 days
- Class
- Class II
- Product code
- KPS
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK091269 NeuropetPhotodetection Systems, Inc. · 2009
- Descendant · cites it directly · 4 of its ownK210450 BBX-PET ScannerPrescient Imaging, LLC · 2021
- Descendant · 2 generations on · 0 of its ownK250170 PharosBrightonix Imaging · 2025
- Descendant · 2 generations on · 0 of its ownK241751 NeuroLF (Basic); NeuroLF (Pro); NeuroLF (Advanced); NeuroLF SeatPositrigo AG · 2024
- Descendant · 2 generations on · 0 of its ownK240827 SET-5002Shimadzu Corporation Medical Systems Division · 2024
- Descendant · 2 generations on · 0 of its ownK232569 CaremibrainGeneral Equipment For Medical Imaging, S.A. · 2023
Most influential descendants
Showing 5 of 5 · See all- K210450BBX-PET ScannerPrescient Imaging, LLC · 2021 · cites it directly4descendants
- K250170PharosBrightonix Imaging · 2025 · 2 generations on0descendants
- K241751NeuroLF (Basic); NeuroLF (Pro); NeuroLF (Advanced); NeuroLF SeatPositrigo AG · 2024 · 2 generations on0descendants
- K240827SET-5002Shimadzu Corporation Medical Systems Division · 2024 · 2 generations on0descendants
- K232569CaremibrainGeneral Equipment For Medical Imaging, S.A. · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K091269 | Neuropet | Photodetection Systems, Inc. | 2009 | — |
| +1 | K210450 | BBX-PET Scanner | Prescient Imaging, LLC | 2021 | — |
| +2 | K250170 | Pharos | Brightonix Imaging | 2025 | — |
| +2 | K241751 | NeuroLF (Basic); NeuroLF (Pro); NeuroLF (Advanced); NeuroLF Seat | Positrigo AG | 2024 | — |
| +2 | K240827 | SET-5002 | Shimadzu Corporation Medical Systems Division | 2024 | — |
| +2 | K232569 | Caremibrain | General Equipment For Medical Imaging, S.A. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 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 KPS? 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 KPS device
- #1 K253564 uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI…score 18.7 · 17 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 |
|---|---|---|---|
| * | — | Toshiba Medical Systems PCA-8000A, Mark II, PET / CT System Named without a submission number |
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 |
|---|---|---|---|
| K210450 | BBX-PET Scanner | 2021 | 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?
- Of its descendants, K210450 (Prescient Imaging, LLC, 2021) has gone furthest, with 4 descendants of its own.
How does its category compare?
All KPS devicesKPS System, Tomography, Computed, Emission: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · KPS
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KPS
65in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KPS
16in 2025
Class I (17 since 2007) Class II/III not classified
Adverse event reports per year · KPS
36in 2025
MAUDE reports naming product code KPS, 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 | 8 | 38 | 22 | 38 |
| 2008 | 17 | 25 | 16 | 11 |
| 2009 | 9 | 42 | 14 | 15 |
| 2010 | 3 | 91 | 4 | 44 |
| 2011 | 7 | 28 | 34 | 56 |
| 2012 | 6 | 94 | 13 | 34 |
| 2013 | 11 | 84 | 13 | 240 |
| 2014 | 11 | 92 | 18 | 33 |
| 2015 | 3 | 112 | 5 | 24 |
| 2016 | 11 | 65 | 16 | 10 |
| 2017 | 11 | 104 | 11 | 31 |
| 2018 | 13 | 59 | 12 (3) | 26 |
| 2019 | 3 | 60 | 5 (5) | 105 |
| 2020 | 12 | 72 | 8 | 22 |
| 2021 | 15 | 66 | 4 | 10 |
| 2022 | 5 | 60 | 8 (6) | 15 |
| 2023 | 12 | 63 | 6 (3) | 22 |
| 2024 | 11 | 59 | 15 | 23 |
| 2025 | 12 | 65 | 16 | 36 |
| 2026 | 6 | 67 | 6 | — |
What is it indicated for?
This device is a Positron Emission Tomography (PET) system used to detect and display the distribution of positron emitting radionuclides in parts of the human body that will fit in the patient aperture. This device is to be used by trained healthcare professionals. This information can assist in research, diagnosis, therapeutic planning and therapeutic outcome assessment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091269 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091269: Neuropet.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091269
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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