Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Btl — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K202199 | BTL-899ST | Btl | 2021-01-26 | 174 | 0 |
| K200382 | BTL-703-2 | Btl | 2021-01-06 | 323 | 0 |
| K193201 | BTL-785F | Btl | 2020-08-21 | 275 | 0 |
| K192224 | BTL-899 | Btl | 2019-12-05 | 111 | 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