Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
B. Braun Medizintechnologie GmbH · 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) |
|---|---|---|---|---|---|
| K072760 | SOLCART B | B. Braun Medizintechnologie GmbH | 2008-01-29 | 123 | 0 |
| K071518 | DIACAP LO PS (10, 12, 15) AND DIACAP HI PS (10, 12, 15, 18, | B. Braun Medizintechnologie GmbH | 2007-08-17 | 74 | 0 |
| K052764 | DIACAP ULTRA DIALYSIS FLUID FILTER | B. Braun Medizintechnologie GmbH | 2006-06-09 | 252 | 1 |
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