510(k) · Cleared
ClearedCal/Rad Mark VI/VDC-505 Dose Calibrator, Model 34-165
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nuclear Associates · KPT Calibrator, Dose, Radionuclide
Cleared on Aug 29, 2003 after a 234-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 later devices descend from it.
- Decided
- Aug 29, 2003
- Review
- 234 days
- Class
- Class II
- Product code
- KPT
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK030066 Cal/Rad Mark VI/VDC-505 Dose Calibrator, Model 34-165Nuclear Associates · 2003
- Descendant · cites it directly · 0 of its ownK142325 Veenstra Instruments VDC-506 Dose CalibratorComecer Netherlands B.V. · 2014
- Descendant · cites it directly · 0 of its ownK080297 Medrad Intego Pet Infusion SystemMedrad, Inc. · 2008 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K030066 | Cal/Rad Mark VI/VDC-505 Dose Calibrator, Model 34-165 | Nuclear Associates | 2003 | — |
| +1 | K142325 | Veenstra Instruments VDC-506 Dose Calibrator | Comecer Netherlands B.V. | 2014 | — |
| +1 | K080297 | Medrad Intego Pet Infusion System | Medrad, Inc. | 2008 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2014 | 1 | 0 |
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? (2)
2 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, K142325 (Comecer Netherlands B.V., 2014) has gone furthest, with 0 descendants of its own.
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?
The Mark VI Dose Calibrator is designed to measure the amount of radioactive material in vials, syringes and capsules. It is used to measure the amount of activity used to prepare radiopharmaceutical kits, measure the activity in syringes of radiopharmaceuticaIs prior to injection and to quantify the activity remaining in the syringe following injection. It is indicated for use in the preparation of radiopharmaceuticals and verification of the ac$vity…
Read the full statement (144 words)
The Mark VI Dose Calibrator is designed to measure the amount of radioactive material in vials, syringes and capsules. It is used to measure the amount of activity used to prepare radiopharmaceutical kits, measure the activity in syringes of radiopharmaceuticaIs prior to injection and to quantify the activity remaining in the syringe following injection. It is indicated for use in the preparation of radiopharmaceuticals and verification of the ac$vity prior to patient administration.
Data related to the factory calibration is stored in the chamber. This standardizes the response of each ion chamber, allowing each chamber to report the same amount of electric current for the same radiation source. The isotopic calibration factors are stored in the controlheadout unit. The ion chamber current is processed using the isotopic calibration factors stored in the control unit in order to determine the amount of radioactive material present.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K030066 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030066: Cal/Rad Mark VI/VDC-505 Dose Calibrator, Model 34-165.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030066
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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