510(k) · Cleared
ClearedCapintec CRC 55T Series Dose Calibrators, Models CRC 55TR, CRC 55TPET and CRC 55TW
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Capintec, Inc. · KPT Calibrator, Dose, Radionuclide
Cleared on Aug 9, 2010 after a 76-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- Aug 9, 2010
- Review
- 76 days
- Class
- Class II
- Product code
- KPT
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK101452 Capintec CRC 55T Series Dose Calibrators, Models CRC 55TR, CRC…Capintec, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK162394 CRC-77tHRCapintec, Inc. · 2017
Most influential descendants
Showing 1 of 1 · See all- K162394CRC-77tHRCapintec, Inc. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K101452 | Capintec CRC 55T Series Dose Calibrators, Models CRC 55TR, CRC 55TPET and CRC… | Capintec, Inc. | 2010 | — |
| +1 | K162394 | CRC-77tHR | Capintec, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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 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? (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 |
|---|---|---|---|
| * | — | CRC 25 series Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K162394 | CRC-77tHR | 2017 | 0 |
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, K162394 (Capintec, Inc., 2017) 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. 2010, this device’s year, is highlighted.
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 CRC 55t series, which includes the standard S5tR dose calibrator, reduced pressure chamber (CRC S5tPET) and well counter (CRC55tW), is intended to be used by qualified nuclear medicine technologists, nuclear medicine physicians, and radiopharmacists to measure a wide range of radiopharmaceuticals and radioactive materials, including high energy beta and gamma emitters for diagnostic, therapeutic, or in vitro laboratory tests. It is also designed for…
Read the full statement (130 words)
The CRC 55t series, which includes the standard S5tR dose calibrator, reduced pressure chamber (CRC S5tPET) and well counter (CRC55tW), is intended to be used by qualified nuclear medicine technologists, nuclear medicine physicians, and radiopharmacists to measure a wide range of radiopharmaceuticals and radioactive materials, including high energy beta and gamma emitters for diagnostic, therapeutic, or in vitro laboratory tests. It is also designed for use by trained medical physicists to measure the output of most radioactive brachytherapy sources, including LDR, HDR, and IVBT sources. All brachytherapy sources must be measured in the appropriate source holder. The well counter is designed for measurement of low activity radioactive sources or solutions including in vitro laboratory test applications. This device is also used in numerous research applications for measurement of radioactive materials.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101452 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101452: Capintec CRC 55T Series Dose Calibrators, Models CRC 55TR, CRC 55TPET and CRC 55TW.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101452
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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