FDA product code KPS: System, Tomography, Computed, Emission
KPS is the FDA product code for system, tomography, computed, emission. It is a Class II device, regulated under 21 CFR 892.1200 and reviewed by the Radiology panel. FDA has cleared 473 510(k) submissions under KPS, 46 in the last five years, from 131 different applicants. The average 510(k) review took 84 days (median 75); 85 days on average over the last three years. FDA has posted 449 recalls for KPS devices, 60 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | System, Tomography, Computed, Emission |
| Device class | Class II |
| Regulation | 21 CFR 892.1200 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for KPS
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 11 | 104 |
| 2018 | 13 | 98 |
| 2019 | 3 | 75 |
| 2020 | 12 | 89 |
| 2021 | 15 | 80 |
| 2022 | 5 | 75 |
| 2023 | 12 | 78 |
| 2024 | 11 | 77 |
| 2025 | 12 | 106 |
| 2026 | 6 | 71 |
Compare with all 510(k) review times · Search every KPS clearance
Top KPS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Siemens Medical Solutions USA, Inc. | 46 | 2026-05-21 |
| Adac Laboratories | 35 | 2006-08-23 |
| Philips Medical Systems (Cleveland), Inc. | 20 | 2017-10-06 |
| Shanghai United Imaging Healthcare Co., Ltd. | 18 | 2026-07-28 |
| Cti Pet Systems, Inc. | 18 | 2005-03-25 |
126 more applicants have KPS clearances. See the full list in Caduvo.
Most recent KPS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261305 | Microstructure Imaging, Inc. | MICSI-PET | 2026-09-11 | 144 |
| K261427 | Shanghai United Imaging Healthcare Co., Ltd. | uMI Panvivo (uMI Panvivo M) | 2026-07-28 | 89 |
| K261315 | Siemens Medical Solutions USA, Inc. | Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.specta X7 (11364753);Symbia Pro.specta VA40 Family | 2026-05-21 | 30 |
| K260524 | Shanghai United Imaging Healthcare Co., Ltd. | uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES) | 2026-04-03 | 45 |
| K253564 | Shanghai United Imaging Healthcare Co., Ltd. | uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES) | 2026-02-13 | 88 |
Recalls for KPS devices
449 product recalls in 184 recall events; 60 initiated in the last five years and 84 still open. Most recent: 2026-08-11.
| Year | Recalls |
|---|---|
| 2017 | 29 |
| 2018 | 21 |
| 2019 | 16 |
| 2020 | 19 |
| 2021 | 11 |
| 2022 | 8 |
| 2023 | 11 |
| 2024 | 16 |
| 2025 | 19 |
| 2026 | 6 |
Frequently asked questions
What is FDA product code KPS?
KPS is the FDA product code for system, tomography, computed, emission. It is a Class II device, regulated under 21 CFR 892.1200 and reviewed by the Radiology panel.
What device class is KPS?
Class II, regulation 21 CFR 892.1200. Typical premarket route: 510(k).
How long does a 510(k) take for product code KPS?
Across 473 cleared submissions the average was 84 days from receipt to decision (median 75).
Which companies have the most KPS clearances?
Siemens Medical Solutions USA, Inc. (46); Adac Laboratories (35); Philips Medical Systems (Cleveland), Inc. (20); Shanghai United Imaging Healthcare Co., Ltd. (18); Cti Pet Systems, Inc. (18).
Have KPS devices been recalled?
Yes: 449 product recalls across 184 recall events; the most recent began 2026-08-11.
Next steps
- Run an FDA pathway report with predicate devices for product code KPS
- Run a recall and safety report across every KPS manufacturer
- Watch product code KPS for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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