Capintec, Inc.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Capintec, Inc.” (first 1978, latest 2019), across 7 product codes in 3 review panels. Median 510(k) review time under this name: 78 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 1 | 29 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 194 |
| 2018 | 0 | — |
| 2019 | 1 | 30 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Capintec, Inc. took a median 112 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 119 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KPT | Calibrator, Dose, Radionuclide | 6 | 6 |
| IYE | Accelerator, Linear, Medical | 2 | 2 |
| JJJ | Counter (Beta, Gamma) For Clinical Use | 2 | 2 |
| DSH | Recorder, Magnetic Tape, Medical | 1 | 1 |
| IYY | Synchronizer, Electrocardiograph, Nuclear | 1 | 1 |
| JAD | System, Therapeutic, X-Ray | 1 | 1 |
| JAQ | System, Applicator, Radionuclide, Remote-Controlled | 1 | 1 |
Review panels
- Radiology (11)
- Clinical Chemistry (2)
- Cardiovascular (1)
Most recent Capintec, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K192199 | CRC PC Smart Chamber K1 | KPT | 2019-09-12 | 30 |
| K162394 | CRC-77tHR | KPT | 2017-03-08 | 194 |
| K141413 | CRC PC WITH SMART CHAMBER | KPT | 2014-06-27 | 29 |
| K101452 | CAPINTEC CRC 55T SERIES DOSE CALIBRATORS, MODELS CRC 55TR, CRC 55TPET AND CRC 55TW | KPT | 2010-08-09 | 76 |
| K071396 | CRC 25 SERIES (CRC 25R, CRC 25PET, CRC 25W) DOSE CALIBRATORS | KPT | 2007-06-28 | 38 |
| K052595 | CRC 15ULTRA | JAQ | 2005-11-08 | 48 |
| K030175 | 2 BASIC | IYE | 2003-04-17 | 90 |
| K020150 | CRC-15BT | KPT | 2002-08-02 | 198 |
| K982448 | CARDIOLIGHT | DSH | 1999-06-11 | 331 |
| K980402 | CAPINTEC MODEL 292 ELECTROMETER | IYE | 1998-04-24 | 81 |
4 earlier clearances. See the full list in Caduvo.
Recalls
6 product recalls in 5 recall events; 0 initiated in the last five years. Most recent: 2020-03-03.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Capintec Instruments, Inc. (7 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Capintec, Inc.?
FDA lists 14 510(k) clearances under the applicant name “Capintec, Inc.” (first 1978, latest 2019), across 7 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Capintec, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Capintec, Inc. is 78 days.
Which FDA product codes appear under Capintec, Inc.?
The most frequent FDA product codes under this applicant name are KPT (Calibrator, Dose, Radionuclide, 6); IYE (Accelerator, Linear, Medical, 2); JJJ (Counter (Beta, Gamma) For Clinical Use, 2).
Next steps
- See all 14 Capintec, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KPT, Capintec, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.