# KPT: Calibrator, Dose, Radionuclide

- Device class: 2; regulation: 21 CFR 892.1360; FDA's rule: 510(k) required
- FDA decisions: 32
- Recalls: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2001: 2
- 2002: 3
- 2003: 1
- 2004: 1
- 2007: 1
- 2009: 1
- 2010: 1
- 2014: 2
- 2017: 1
- 2019: 1

## Most-cited predicates
- K030066: Cal/Rad Mark VI/VDC-505 Dose Calibrator, Model 34-165 (2003), cited by 2
- K101452: Capintec CRC 55T Series Dose Calibrators, Models CRC 55TR, CRC 55TPET and CRC 55TW (2010), cited by 1
- K141413: CRC PC with Smart Chamber (2014), cited by 1
- K071396: CRC 25 Series (CRC 25R, CRC 25PET, CRC 25W) Dose Calibrators (2007), cited by 1
- K884312: Atomlab 100, Model 086-250 & 200 Model 086-270 (1989), cited by 1

Source page: https://510kreport.com/product-code/KPT
Data by year (CSV): https://510kreport.com/product-code/KPT.csv