Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Bt Medical Co., Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
145 daysmedian FDA review time
238 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K931268 | URETERAL COMPRESSION DEVICE | Bt Medical Co., Inc. | 1993-07-19 | 133 | 0 |
| K930885 | PNEUMATIC COMPRESSION DEVICE | Bt Medical Co., Inc. | 1993-07-13 | 145 | 0 |
| K931269 | LEAD APRON | Bt Medical Co., Inc. | 1993-06-02 | 86 | 0 |
| K915321 | BTM-200 (PROPOSED) POWERED MUSCLE STIMULATOR | Bt Medical Co., Inc. | 1992-07-17 | 238 | 0 |
| K914999 | BTM-100 POWERED MUSCLE STIMULATOR (PROPOSED) | Bt Medical Co., Inc. | 1992-04-23 | 168 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda