Product code KPS: 510(k) clearances and predicates
Product code KPS covers MICSI-PET. FDA lists 473 clearances under this code in the 510(k) index. This page summarizes recent clearance volume and names recent clearances by K number so you can pick predicates faster.
Clearance volume
473 clearances on file under product code KPS. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 5 |
| 2023 | 12 |
| 2024 | 11 |
| 2025 | 12 |
| 2026 so far | 6 |
Recent clearances
Newest KPS clearances in the FDA index, with applicant and decision date:
- K261305, MICSI-PET, applicant Microstructure Imaging, Inc., decided 2026-09-11. FDA record
- K261427, uMI Panvivo (uMI Panvivo M), applicant Shanghai United Imaging Healthcare Co., Ltd., decided 2026-07-28. FDA record
- K261315, Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.specta X7 (11364753);Symbia Pro.specta VA40 Family, applicant Siemens Medical Solutions USA, Inc., decided 2026-05-21. FDA record
- K260524, uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES), applicant Shanghai United Imaging Healthcare Co., Ltd., decided 2026-04-03. FDA record
- K253564, uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES), applicant Shanghai United Imaging Healthcare Co., Ltd., decided 2026-02-13. FDA record
- K254001, VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464), applicant Spectrum Dynamics Medical, Ltd., decided 2026-01-13. FDA record
- K253844, AnyScan 3.0 NM Scanner Family, applicant Mediso Medical Imaging Systems, Ltd., decided 2025-12-30. FDA record
- K251370, Cartesion Prime (PCD-1000A/3) V10.21, applicant Canon Medical Systems Corporation, decided 2025-12-01. FDA record
What this means for a regulatory watcher
Volume tells you how deep the predicate pool is. A code with steady yearly counts gives you many candidate predicates, which helps when one predicate has a recall or design gap. A code with a sharp recent rise means reviewers are seeing more of this device type, so substantial equivalence arguments need to track the newest cleared devices, not five year old ones. Related device names in recent clearances include uMI Panvivo (uMI Panvivo M), Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.specta X7 (11364753);Symbia Pro.specta VA40 Family. Watch new KPS clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.
FAQ
What is FDA product code KPS?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent KPS clearances include MICSI-PET.
How many 510(k) clearances use product code KPS?
473 at the time this page was generated, from openFDA records.
How do I find a predicate device under KPS?
Start with the recent K numbers listed above, then run the free predicate search to check substantial equivalence text and review history.
How do I track new KPS clearances?
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.