Technicare Corp.: FDA clearances and approvals
Technicare Corp. has 32 FDA 510(k) clearances (first 1980, latest 1985), across 9 product codes in 3 review panels. Median 510(k) review time: 45 days.
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 |
|---|---|---|---|
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 8 | 8 |
| JAK | System, X-Ray, Tomography, Computed | 4 | 4 |
| IYX | Camera, Scintillation (Gamma) | 3 | 3 |
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 2 | 2 |
| GXX | Block, Test, Ultrasonic Scanner Calibration | 1 | 1 |
| ISD | Exerciser, Measuring | 1 | 1 |
| IYE | Accelerator, Linear, Medical | 1 | 1 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 1 | 1 |
Plus 1 more product codes.
Review panels
- Radiology (19)
- Neurology (1)
- Physical Medicine (1)
Most recent Technicare Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K854340 | TECHNICARE 720 HPS CT SCANNER | JAK | 1985-11-15 | 18 |
| K852089 | SATURN NUCLEAR MEDICINE COMPUTER SYSTEM | IYX | 1985-07-18 | 66 |
| K844293 | AUTO DII MULTI FREQUENCY | IYN | 1985-02-13 | 100 |
| K844247 | ULTRASONIC SCANNER CALIBRATION & TEST PHANTOMS | GXX | 1985-01-23 | 83 |
| K843716 | NUCLEAR 700 MEDICINE MECHANICAL POSIT- | IYX | 1984-12-17 | 84 |
| K842777 | AUTOFOCUS DUAL ELEMENT PROBE | IYO | 1984-11-29 | 136 |
| K841817 | TECHNICARE 248 SL & 260SL | IYO | 1984-08-17 | 108 |
| K840860 | CENTAURI CT SCANNER | JAK | 1984-05-22 | 88 |
| K840540 | TECHNICARE MODEL 330 | IYO | 1984-05-09 | 91 |
| K834486 | TECHNICARE 280 | IYO | 1984-04-13 | 128 |
22 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Technicare Corp..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Technicare Corp. have?
Technicare Corp. has 32 FDA 510(k) clearances (first 1980, latest 1985), across 9 product codes in 3 review panels.
How long does FDA take to clear Technicare Corp.'s 510(k)s?
The median time from FDA receipt to decision across Technicare Corp.'s cleared 510(k)s is 45 days.
What devices does Technicare Corp. make?
Its most frequent FDA product codes are IYO (System, Imaging, Pulsed Echo, Ultrasonic, 8); JAK (System, X-Ray, Tomography, Computed, 4); IYX (Camera, Scintillation (Gamma), 3).
Has Technicare Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Technicare Corp. Related entities may recall under other names.
Next steps
- See all 32 Technicare Corp. clearances with predicates and recalls
- Run predicate analysis for product code IYO, Technicare Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.