Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Btl Industries, Ltd. — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K134040 | BTL-9000; BTL-9000 RADIOFREQUENCY MODULE | Btl Industries, Ltd. | 2014-09-10 | 253 | 0 |
| K122966 | XP200 | Btl Industries, Ltd. | 2013-04-08 | 195 | 0 |
| K092191 | EXILIS, MODEL 5000 | Btl Industries, Ltd. | 2009-11-25 | 127 | 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