510(k) · Cleared
ClearedPet-Dose
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Comecer S.R.L. · KPT Calibrator, Dose, Radionuclide
Cleared on Nov 22, 2004 after a 49-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Nov 22, 2004
- Review
- 49 days
- Class
- Class II
- Product code
- KPT
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KPT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
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.
How does its category compare?
All KPT devicesKPT Calibrator, Dose, Radionuclide: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KPT
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · KPT
Too few KPT 510(k)s in any year since 2007 to give a median.
Recalls per year · KPT
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KPT
No MAUDE report names KPT since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 1 | 0 |
| 2011 | 0 | — | 1 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
PET-Dose is a radionuclide dose calibrator designed to measure the amount of radioactity in vials, syringes, and in any other user-defined geometry samples. It is intended to assay radiopharmaceuticals before their administration to patients, by measuring the residual of radiopharmaceutical in vials, the activity of the injectable in syringes, the activity of capsules before they are administered to patients, etc. The best applications of PET-Dose are…
Read the full statement (129 words)
PET-Dose is a radionuclide dose calibrator designed to measure the amount of radioactity in vials, syringes, and in any other user-defined geometry samples. It is intended to assay radiopharmaceuticals before their administration to patients, by measuring the residual of radiopharmaceutical in vials, the activity of the injectable in syringes, the activity of capsules before they are administered to patients, etc. The best applications of PET-Dose are activity measurements of beta~ emitters used in PET diagnostics such as: ' 8F, 13N, 150, etc.
PET-Dose is best fitted for use in nuclear medicine departments and, particularly, in PET centers.
The PET-Dose is intended to be used by trained medical physicist or qualified experts or nuclear medicine technicians to perform activity measurements in the nuclear medicine departments and, particularly, in PET centers.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K042746 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042746: Pet-Dose.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042746
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026