Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
B. Braun Avitum AG — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
264 daysmedian FDA review time
454 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K170574 | Diacap Pro Dialyzer | B. Braun Avitum AG | 2017-08-11 | 165 | 0 |
| K143482 | xevonta dialyzer | B. Braun Avitum AG | 2016-03-01 | 449 | 0 |
| K102194 | SOLCART B | B. Braun Avitum AG | 2011-04-25 | 264 | 0 |
| K100334 | DIACAP POLYSULFONE HIFLO 23 HEMODILAYZER , MODEL 72036811 | B. Braun Avitum AG | 2010-04-22 | 76 | 0 |
| K083460 | DIALOG WITH ADIMEA OPTION | B. Braun Avitum AG | 2010-02-18 | 454 | 6 |
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