Medi-Tech, Inc.: FDA filings under this applicant name
FDA lists 36 510(k) clearances under the applicant name “Medi-Tech, Inc.” (first 1978, latest 1996), across 26 product codes in 10 review panels. Median 510(k) review time under this name: 68 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 |
|---|---|---|---|
| DIF | Drug Mixture Control Materials | 3 | 3 |
| DTK | Filter, Intravascular, Cardiovascular | 3 | 3 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 3 | 3 |
| DQO | Catheter, Intravascular, Diagnostic | 2 | 2 |
| DQX | Wire, Guide, Catheter | 2 | 2 |
| DQY | Catheter, Percutaneous | 2 | 2 |
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | 2 | 2 |
| BSY | Catheters, Suction, Tracheobronchial | 1 | 1 |
| DKB | Calibrators, Drug Mixture | 1 | 1 |
| DXT | Injector And Syringe, Angiographic | 1 | 1 |
Plus 16 more product codes.
Review panels
- Cardiovascular (12)
- Gastroenterology and Urology (9)
- General and Plastic Surgery (4)
- Clinical Toxicology (4)
- Microbiology (2)
- Anesthesiology (1)
- Clinical Chemistry (1)
- Dental (1)
- Hematology (1)
- General Hospital (1)
Most recent Medi-Tech, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K954457 | MEDI-TECH EDDY INTRAVASCULAR INFUSION CATHETER | KRA | 1996-05-15 | 233 |
| K952345 | MEDI-TECH PLATFORM GUIDE CATHETER | DQY | 1995-08-17 | 90 |
| K952056 | IMMUNOASSAY DRUGS OF ABUSE CONTROLS | DIF | 1995-06-01 | 30 |
| K945289 | DOA - IMMUNOASSAY CUT-OFF CALIBRATOR | DKB | 1994-12-13 | 43 |
| K942551 | THERAPEUTIC DRUG MONITORING CONTROL, ASSAYED | DIF | 1994-10-06 | 128 |
| K943290 | BILIRUBIN PLUS/PEDIATRIC CONTROLS | JJY | 1994-09-14 | 68 |
| K922990 | HEMODIALYSIS BATH | KPO | 1994-09-12 | 812 |
| K942552 | THERAPEUTIC DRUG MONITORING CONTROL, UNASSAYED | DIF | 1994-09-09 | 101 |
| K904073 | COAGULATION REFERENCE PLASMA, ABNORMAL | GGC | 1990-10-22 | 47 |
| K895819 | MODIFIED LABELING TO THE SPAND-GEL GRANULATED GEL | KMF | 1989-11-02 | 34 |
26 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Medi-Tech, 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.
- Medi-Tech Intl. Corp. (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Medi-Tech, Inc.?
FDA lists 36 510(k) clearances under the applicant name “Medi-Tech, Inc.” (first 1978, latest 1996), across 26 product codes in 10 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 Medi-Tech, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medi-Tech, Inc. is 68 days.
Which FDA product codes appear under Medi-Tech, Inc.?
The most frequent FDA product codes under this applicant name are DIF (Drug Mixture Control Materials, 3); DTK (Filter, Intravascular, Cardiovascular, 3); KNT (Tubes, Gastrointestinal (And Accessories), 3).
Next steps
- See all 36 Medi-Tech, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DIF, Medi-Tech, 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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.