Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
B. Braun of America, Inc. · Predicate Candidate Screening
19 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
186 daysmedian FDA review time
319 days90th percentile
19clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K993024 | CELSITE IMPLANTABLE PORT WITH VALVED CATHETER | B. Braun of America, Inc. | 2000-03-13 | 186 | 1 |
| K983794 | CHEMO MINI SPIKE PLUS | B. Braun of America, Inc. | 1999-03-23 | 147 | 0 |
| K946170 | COMFORT-Q SUBCUTANEOUS INJECTION SETS | B. Braun of America, Inc. | 1995-11-03 | 319 | 0 |
| K945850 | BRAUN DIACAN(R) FISTULA NEEDLES | B. Braun of America, Inc. | 1995-10-06 | 310 | 0 |
| K942988 | FILTERED EXTENSION SETS | B. Braun of America, Inc. | 1995-07-14 | 389 | 26 |
| K945752 | CELSITE(TM) BRACHIAL VENOUS PORT | B. Braun of America, Inc. | 1995-05-31 | 189 | 0 |
| K945551 | CELSITE(TM) DUAL VENOUS SYSTEM | B. Braun of America, Inc. | 1995-04-21 | 158 | 0 |
| K943770 | LOW VOLUME MULTIPORT | B. Braun of America, Inc. | 1995-04-10 | 251 | 11 |
| K950982 | B. BRAUN SONOCAN BIOPSY NEEDLE AND ASPIRATION HANDLE | B. Braun of America, Inc. | 1995-04-04 | 32 | 0 |
| K950184 | B. BRAUN IV START KITS | B. Braun of America, Inc. | 1995-03-15 | 57 | 0 |
| K943181 | DISPENSING PIN WITH ONE-WAY VALVE | B. Braun of America, Inc. | 1994-09-29 | 90 | 2 |
| K940980 | CHARGED SUPOR(R) FILTER EXTENSION SET | B. Braun of America, Inc. | 1994-07-14 | 135 | 0 |
| K932569 | PENCIL POINT SPINAL NEEDLE AND TRAY | B. Braun of America, Inc. | 1994-01-26 | 244 | 2 |
| K932400 | ESPOCAN COMBINED SPINAL/EPIDURAL NEEDLE SET & TRAY | B. Braun of America, Inc. | 1993-12-13 | 209 | 0 |
| K925285 | DUALTHERM(R) CARDIAC OUTPUT COMPUTER | B. Braun of America, Inc. | 1993-07-21 | 274 | 0 |
| K925401 | IV FLUID TRANSFER PIN | B. Braun of America, Inc. | 1993-03-03 | 128 | 0 |
| K915421 | GUIDEWIRE INTRODUCER SET | B. Braun of America, Inc. | 1992-02-27 | 87 | 0 |
| K910503 | DISCOGRAPHY KIT | B. Braun of America, Inc. | 1991-10-07 | 244 | 0 |
| K911415 | TRUMPET VALVE | B. Braun of America, Inc. | 1991-06-03 | 63 | 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