Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Btg International, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
122 daysmedian FDA review time
262 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K191119 | EkoSonic Endovascular Device | Btg International, Inc. | 2019-08-23 | 119 | 0 |
| K183361 | EkoSonic Endovascular Device with Control Unit 4.0 | Btg International, Inc. | 2019-04-05 | 122 | 1 |
| K182324 | EkoSonic Endovascular System | Btg International, Inc. | 2018-11-26 | 91 | 0 |
| K172035 | EKOS ultrasound EVD Device, EVD Control Unit | Btg International, Inc. | 2018-03-24 | 262 | 0 |
| K162771 | EkoSonic Endovascular System with Control Unit 4.0 | Btg International, Inc. | 2017-02-24 | 144 | 1 |
| K140151 | EKOSONIC MACH 4 ENDOVASCULAR DEVICE/EKOSONIC CONTROL UNIT | Btg International, Inc. | 2014-05-21 | 119 | 2 |
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