Clinical Technology Corp.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Clinical Technology Corp.” (first 1982, latest 1994), across 10 product codes in 6 review panels. Median 510(k) review time under this name: 89 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 |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 3 | 3 |
| EFB | Handpiece, Air-Powered, Dental | 1 | 1 |
| FLL | Continuous Measurement Thermometer | 1 | 1 |
| FRC | Indicator, Biological Sterilization Process | 1 | 1 |
| GHM | Test, Sickle Cell | 1 | 1 |
| LBK | Neurosurgical Ultrasonic Instruments | 1 | 1 |
| LCP | Assay, Glycosylated Hemoglobin | 1 | 1 |
| LFL | Instrument, Ultrasonic Surgical | 1 | 1 |
| LXH | Orthopedic Manual Surgical Instrument | 1 | 1 |
Plus 1 more product codes.
Review panels
- General and Plastic Surgery (4)
- Hematology (2)
- General Hospital (2)
- Dental (1)
- Neurology (1)
- Orthopedic (1)
Most recent Clinical Technology Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K925080 | TEK-LUBE | EFB | 1994-01-31 | 481 |
| K872867 | BIOSIGN | FRC | 1988-07-06 | 351 |
| K880166 | BOVIE ULTRASONIC SURGICAL ASPIRATOR, MODEL ME2000 | LFL | 1988-02-18 | 35 |
| K872705 | BOVIE 400-CT ELECTROSURGICAL GENERATOR (UNIT) | GEI | 1987-09-01 | 56 |
| K855138 | BOVIE ULTRASONIC SURGICAL SYSTEM | LBK | 1986-11-10 | 322 |
| K854231 | ELECTROSURGICAL CUTTING & COAGULATION DEVICE/ACCES | GEI | 1986-05-02 | 193 |
| K853507 | STERI-GRIP | — | 1985-09-05 | 15 |
| K852986 | GLYCO-SEP/ALC TEST KIT FOR SEPARAT OF HEMOGLOBIN | LCP | 1985-08-19 | 35 |
| K844565 | BOVIE X-10 ELECTROSURGICAL GENERATOR(UNIT) | GEI | 1985-02-21 | 90 |
| K841272 | SICKLE-STAT HEMOGLOBIN S SCREEN KIT | GHM | 1984-04-13 | 17 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Clinical Technology Corp..
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.
- Clinical Data, Inc. (37 510(k)s)
- Clinical Sciences, Inc. (30 510(k)s)
- Clinical Assays, Inc. (27 510(k)s)
- Clinical Controls, Inc. (18 510(k)s)
- Clinical Resources, Inc. (14 510(k)s)
- Clinical Connections, Inc. (10 510(k)s)
- Clinical Innovations, Inc. (9 510(k)s)
- Clinical Innovations, LLC (9 510(k)s)
- Clinical Diagnostics, Inc. (8 510(k)s)
- Clinical Convenience Products, Inc. (6 510(k)s)
- Clinical Laserthermia Systems, AB (6 510(k)s)
- Clinical Neuro Systems, LLC (5 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Clinical Technology Corp.?
FDA lists 12 510(k) clearances under the applicant name “Clinical Technology Corp.” (first 1982, latest 1994), across 10 product codes in 6 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 Clinical Technology Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Clinical Technology Corp. is 89 days.
Which FDA product codes appear under Clinical Technology Corp.?
The most frequent FDA product codes under this applicant name are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 3); EFB (Handpiece, Air-Powered, Dental, 1); FLL (Continuous Measurement Thermometer, 1).
Next steps
- See all 12 Clinical Technology Corp. clearances with predicates and recalls
- Run predicate analysis for product code GEI, Clinical Technology Corp.'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.