Meditech International, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Meditech International, Inc.” (first 2003, latest 2008), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 218 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 |
|---|---|---|---|
| ILY | Lamp, Infrared, Therapeutic Heating | 4 | 4 |
| NHN | Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy | 1 | 1 |
Review panels
Most recent Meditech International, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K081355 | BIOFLEX LD-R100 TREATMENT HEAD | ILY | 2008-12-18 | 218 |
| K072551 | LD-I 75 AND LD-I 200 | NHN | 2008-04-02 | 205 |
| K051875 | BIOFLEX PRESCRIPTION SYSTEM AND RELATED TREATMENT HEADS | ILY | 2006-03-13 | 245 |
| K041885 | BIOFLEX LD-175 AND LD-1200 TREATMENT HEADS | ILY | 2005-02-24 | 227 |
| K023621 | BIOFLEX PROFESSIONAL THERAPY SYSTEM | ILY | 2003-04-10 | 163 |
Recalls
openFDA lists no recalls under a recalling firm named Meditech International, 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.
- Meditech Spine, LLC (10 510(k)s)
- Meditech , Ltd. (3 510(k)s)
- Meditech Advisors, LLC (2 510(k)s)
- Meditech Gloves Sdn Bhd (2 510(k)s)
- Meditech Kft. (2 510(k)s)
- Meditech Endoscopy, Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Meditech International, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Meditech International, Inc.” (first 2003, latest 2008), across 2 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 Meditech International, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Meditech International, Inc. is 218 days.
Which FDA product codes appear under Meditech International, Inc.?
The most frequent FDA product codes under this applicant name are ILY (Lamp, Infrared, Therapeutic Heating, 4); NHN (Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy, 1).
Next steps
- See all 5 Meditech International, Inc. clearances with predicates and recalls
- Run predicate analysis for product code ILY, Meditech International, 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.