510(k) · Cleared
ClearedCRC-77tHR
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 Mar 8, 2017 as substantially equivalent to K101452 (Capintec, Inc., 2010) after a 194-day review. Its family tree reaches back 1 generation to 2010.
- Decided
- Mar 8, 2017
- Review
- 194 days
- Class
- Class II
- Product code
- KPT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K101452 (2010). No later device cites it as a predicate yet.
- Root · 1 generation backK101452 Capintec CRC 55T Series Dose Calibrators, Models CRC 55TR, CRC…Capintec, Inc. · 2010
- This deviceK162394 CRC-77tHRCapintec, Inc. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K101452 | Capintec CRC 55T Series Dose Calibrators, Models CRC 55TR, CRC 55TPET and CRC… | Capintec, Inc. | 2010 | — |
| 0 (this device) | K162394 | CRC-77tHR | Capintec, Inc. | 2017 | — |
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 |
|---|---|---|---|
| * | K101452 | Capintec CRC 55T Series Dose Calibrators, Models CRC 55TR, CRC 55TPET and CRC 55TWSummary page 4…ry Class II, Product Code: KPT (90) 21 CFR 892.1360 III. PREDICATE DEVICE CRC -55t Dose Calibrator series, which received FDA clearance under 510(k) number K101452. This predicate device has not been subject to a design related recall. The predicate devices, Capintec dose calibrator… | 2010 |
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.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All KPT devicesKPT Calibrator, Dose, Radionuclide: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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-77tHR is intended to be used by qualified radiopharmacists, radiochemists, radiation physicists, or other appropriately trained personnel in isotope production sites to measure a wide range of measure a wide range of high activity radiopharmaceuticals and radioactive materials, including high energy beta and gamma emitters. The device is not intended for use with brachytherapy sources. This device is also used in numerous research applications for measurement of high activity levels of radioactive materials.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162394 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162394: CRC-77tHR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162394
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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