Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
B. Braun Instruments — Predicate Candidate Screening
13 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
89 daysmedian FDA review time
89 days90th percentile
13clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K760392 | SYRINGES | B. Braun Instruments | 1976-11-02 | 89 | 1 |
| K760384 | STOPPERS | B. Braun Instruments | 1976-11-02 | 89 | 0 |
| K760382 | CONNECTORS | B. Braun Instruments | 1976-11-02 | 89 | 0 |
| K760391 | CATHETER, VEIN (BRAUNULA) | B. Braun Instruments | 1976-11-02 | 89 | 0 |
| K760380 | INTRAVENOUS TRANSFER SET (INTRAFIX) | B. Braun Instruments | 1976-11-02 | 89 | 0 |
| K760387 | CATHETER, CAVA (CAVAFIX) | B. Braun Instruments | 1976-11-02 | 89 | 0 |
| K760385 | EXTENSION SETS | B. Braun Instruments | 1976-11-02 | 89 | 0 |
| K760383 | STOPCOCKS | B. Braun Instruments | 1976-11-02 | 89 | 6 |
| K760388 | CATHETER, VEIN (VENOFIX) | B. Braun Instruments | 1976-11-02 | 89 | 1 |
| K760381 | BLOOD TRANSFUSION SET (SANGOFIX) | B. Braun Instruments | 1976-11-02 | 89 | 0 |
| K760390 | CATHETER, VEIN (BRAUNULA T) | B. Braun Instruments | 1976-11-02 | 89 | 0 |
| K760389 | CANNULA, IV | B. Braun Instruments | 1976-11-02 | 89 | 0 |
| K760386 | CENTRAL VEINOUS PRESSURE SETS | B. Braun Instruments | 1976-11-02 | 89 | 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