Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Bistos Co., Ltd. — Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
162 daysmedian FDA review time
331 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251512 | Hi bebe super (BT-150B) | Bistos Co., Ltd. | 2025-09-25 | 132 | 0 |
| K232991 | BT-1000 | Bistos Co., Ltd. | 2024-08-28 | 341 | 0 |
| K210289 | Infant Phototherapy Equipment | Bistos Co., Ltd. | 2021-05-28 | 115 | 0 |
| K200675 | Hi bebe super (Models BT-150S and BT-150L) | Bistos Co., Ltd. | 2021-02-10 | 331 | 0 |
| K160274 | Hi bebe plus | Bistos Co., Ltd. | 2016-09-01 | 212 | 0 |
| K142799 | Model BT-220L and BT-220C | Bistos Co., Ltd. | 2015-07-09 | 283 | 0 |
| K132543 | INFANT INCUBATOR | Bistos Co., Ltd. | 2014-07-03 | 324 | 0 |
| K121267 | BT-200V VASCULAR DOPPLER | Bistos Co., Ltd. | 2012-08-02 | 98 | 0 |
| K103545 | BT-350 | Bistos Co., Ltd. | 2011-05-13 | 162 | 0 |
| K100885 | FETAL MONITOR MODEL: BT-200T | Bistos Co., Ltd. | 2010-06-07 | 69 | 0 |
| K052190 | FETAL MONITOR, MODELS BT-300 AND BT-200 | Bistos Co., Ltd. | 2005-10-04 | 54 | 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