Capintec Instruments, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Capintec Instruments, Inc.” (first 1991, latest 1994), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 84 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 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IZD | Probe, Uptake, Nuclear | 3 | 3 |
| KPT | Calibrator, Dose, Radionuclide | 3 | 3 |
| IZO | Generator, High-Voltage, X-Ray, Diagnostic | 1 | 1 |
Review panels
- Radiology (7)
Most recent Capintec Instruments, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K943072 | BETA C COUNTER | KPT | 1994-09-29 | 93 |
| K935539 | CAPINTEC CRC 35R | KPT | 1994-02-18 | 94 |
| K930962 | CAPTUS 2000 WEL COUNTER | IZD | 1993-05-18 | 83 |
| K924586 | CAPTUS 500 WELL DETECTOR W/CLINICAL LABOR SOFTWARE | IZD | 1992-12-03 | 84 |
| K921428 | CAPTUS 500 | IZD | 1992-05-28 | 65 |
| K910020 | CAPINTEC THYROID UPTAKE SYSTEM-VARIOUS MODELS | IZO | 1991-04-08 | 95 |
| K905796 | DOSE CALIBRATOR | KPT | 1991-03-18 | 81 |
Recalls
openFDA lists no recalls under a recalling firm named Capintec Instruments, Inc..
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, Inc. (14 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Capintec Instruments, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Capintec Instruments, Inc.” (first 1991, latest 1994), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Capintec Instruments, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Capintec Instruments, Inc. is 84 days.
Which FDA product codes appear under Capintec Instruments, Inc.?
The most frequent FDA product codes under this applicant name are IZD (Probe, Uptake, Nuclear, 3); KPT (Calibrator, Dose, Radionuclide, 3); IZO (Generator, High-Voltage, X-Ray, Diagnostic, 1).
Next steps
- See all 7 Capintec Instruments, Inc. clearances with predicates and recalls
- Run predicate analysis for product code IZD, Capintec Instruments, 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.