FDA product code KPT: Calibrator, Dose, Radionuclide
KPT is the FDA product code for calibrator, dose, radionuclide. It is a Class II device, regulated under 21 CFR 892.1360 and reviewed by the Radiology panel. FDA has cleared 32 510(k) submissions under KPT, from 19 different applicants. The average 510(k) review took 97 days (median 74). FDA has posted 4 recalls for KPT devices.
Classification
| Field | Value |
|---|---|
| Device name | Calibrator, Dose, Radionuclide |
| Device class | Class II |
| Regulation | 21 CFR 892.1360 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for KPT
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 194 |
| 2019 | 1 | 30 |
Compare with all 510(k) review times · Search every KPT clearance
Top KPT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Capintec, Inc. | 6 | 2019-09-12 |
| Capintec Instruments, Inc. | 3 | 1994-09-29 |
| Radcal Corp. | 3 | 1984-07-16 |
| Sun Nuclear Corp. | 2 | 2002-07-02 |
| Standard Imaging, Inc. | 2 | 2001-11-09 |
14 more applicants have KPT clearances. See the full list in Caduvo.
Most recent KPT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K192199 | Capintec, Inc. | CRC PC Smart Chamber K1 | 2019-09-12 | 30 |
| K162394 | Capintec, Inc. | CRC-77tHR | 2017-03-08 | 194 |
| K142325 | Comecer Netherlands B.V. | Veenstra Instruments VDC-506 Dose Calibrator | 2014-09-18 | 29 |
| K141413 | Capintec, Inc. | CRC PC WITH SMART CHAMBER | 2014-06-27 | 29 |
| K101452 | Capintec, Inc. | CAPINTEC CRC 55T SERIES DOSE CALIBRATORS, MODELS CRC 55TR, CRC 55TPET AND CRC 55TW | 2010-08-09 | 76 |
Recalls for KPT devices
4 product recalls in 3 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2021-08-16.
| Year | Recalls |
|---|---|
| 2021 | 2 |
Frequently asked questions
What is FDA product code KPT?
KPT is the FDA product code for calibrator, dose, radionuclide. It is a Class II device, regulated under 21 CFR 892.1360 and reviewed by the Radiology panel.
What device class is KPT?
Class II, regulation 21 CFR 892.1360. Typical premarket route: 510(k).
How long does a 510(k) take for product code KPT?
Across 32 cleared submissions the average was 97 days from receipt to decision (median 74).
Which companies have the most KPT clearances?
Capintec, Inc. (6); Capintec Instruments, Inc. (3); Radcal Corp. (3); Sun Nuclear Corp. (2); Standard Imaging, Inc. (2).
Have KPT devices been recalled?
Yes: 4 product recalls across 3 recall events; the most recent began 2021-08-16.
Next steps
- Run an FDA pathway report with predicate devices for product code KPT
- Run a recall and safety report across every KPT manufacturer
- Watch product code KPT for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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