Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
B.Braun Melsungen AG · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
149 daysmedian FDA review time
262 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K163358 | Introcan Safety 3 Closed IV Catheter | B.Braun Melsungen AG | 2017-04-28 | 149 | 0 |
| K152050 | Pencylcap | B.Braun Melsungen AG | 2016-03-02 | 223 | 0 |
| K131040 | EXTAVIPRO STERICAN 30G | B.Braun Melsungen AG | 2013-07-15 | 91 | 0 |
| K111236 | INTROCAN SAFETY (R) 3 CLOSED IV CATHETER 18GA X 1-3/4 (45MM) | B.Braun Melsungen AG | 2011-08-30 | 120 | 1 |
| K102033 | COMBITRANS MONITORING SETS AND ACCESSORIES | B.Braun Melsungen AG | 2011-04-07 | 262 | 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