Bt Medical Co., Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Bt Medical Co., Inc.” (first 1992, latest 2003), across 4 product codes in 3 review panels. Median 510(k) review time under this name: 156 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 |
|---|---|---|---|
| IPF | Stimulator, Muscle, Powered | 2 | 2 |
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 2 | 2 |
| EAJ | Apron, Leaded | 1 | 1 |
| NBW | System, Test, Blood Glucose, Over The Counter | 1 | 1 |
Review panels
- Radiology (3)
- Physical Medicine (2)
- Clinical Chemistry (1)
Most recent Bt Medical Co., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K032029 | BTG SMARTEST GLUCOSE TEST SYSTEM | NBW | 2003-12-18 | 170 |
| K931268 | URETERAL COMPRESSION DEVICE | JAA | 1993-07-19 | 133 |
| K930885 | PNEUMATIC COMPRESSION DEVICE | JAA | 1993-07-13 | 145 |
| K931269 | LEAD APRON | EAJ | 1993-06-02 | 86 |
| K915321 | BTM-200 (PROPOSED) POWERED MUSCLE STIMULATOR | IPF | 1992-07-17 | 238 |
| K914999 | BTM-100 POWERED MUSCLE STIMULATOR (PROPOSED) | IPF | 1992-04-23 | 168 |
Recalls
openFDA lists no recalls under a recalling firm named Bt Medical Co., 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Bt Medical Co., Inc.?
FDA lists 6 510(k) clearances under the applicant name “Bt Medical Co., Inc.” (first 1992, latest 2003), across 4 product codes in 3 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 Bt Medical Co., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Bt Medical Co., Inc. is 156 days.
Which FDA product codes appear under Bt Medical Co., Inc.?
The most frequent FDA product codes under this applicant name are IPF (Stimulator, Muscle, Powered, 2); JAA (System, X-Ray, Fluoroscopic, Image-Intensified, 2); EAJ (Apron, Leaded, 1).
Next steps
- See all 6 Bt Medical Co., Inc. clearances with predicates and recalls
- Run predicate analysis for product code IPF, Bt Medical Co., 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.