B.Braun Medical, Inc.: FDA clearances and approvals
B.Braun Medical, Inc. has 150 FDA 510(k) clearances (first 1993, latest 2026), across 45 product codes in 6 review panels. Median 510(k) review time: 140 days. Since 2017 its median was 188 days, against 148 days for all cleared 510(k)s in the same product codes. openFDA lists 509 product recalls by a recalling firm named B.Braun Medical, Inc. It is the industry lead sponsor of 2 device clinical trials on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 3 | 127 |
| 2013 | 2 | 127 |
| 2014 | 4 | 151 |
| 2015 | 4 | 261 |
| 2016 | 5 | 224 |
| 2017 | 4 | 213 |
| 2018 | 5 | 243 |
| 2019 | 1 | 146 |
| 2020 | 5 | 189 |
| 2021 | 2 | 205 |
| 2022 | 5 | 90 |
| 2023 | 2 | 204 |
| 2024 | 3 | 59 |
| 2025 | 1 | 266 |
| 2026 | 2 | 246 |
Review time against the same product codes
Since 2017, B.Braun Medical, Inc.'s cleared 510(k)s took a median 188 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 148 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FPA | Set, Administration, Intravascular | 22 | 22 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 12 | 12 |
| FRN | Pump, Infusion | 11 | 11 |
| DYB | Introducer, Catheter | 9 | 9 |
| LHI | Set, I.V. Fluid Transfer | 9 | 9 |
| CAZ | Anesthesia Conduction Kit | 7 | 7 |
| FRO | Dressing, Wound, Drug | 7 | 7 |
| BSO | Catheter, Conduction, Anesthetic | 6 | 6 |
| BSP | Needle, Conduction, Anesthetic (W/Wo Introducer) | 5 | 5 |
| FMF | Syringe, Piston | 5 | 5 |
Plus 35 more product codes.
Review panels
- General Hospital (83)
- Cardiovascular (21)
- Anesthesiology (19)
- Gastroenterology and Urology (14)
- General and Plastic Surgery (12)
- Radiology (1)
Most recent B.Braun Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K254111 | Irrigation/Urology Sets | LJH | 2026-09-10 | 265 |
| K253235 | Introcan Safety® Deep Access XL IV Catheter | FOZ | 2026-05-15 | 228 |
| K243392 | Infusomat® Space Volumetric Infusion Pump Administration Sets | FPA | 2025-07-24 | 266 |
| K240578 | VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter System | DTK | 2024-07-31 | 152 |
| K241845 | Introcan Safety® 2 IV Catheter | FOZ | 2024-07-26 | 30 |
| K241385 | Omnifix Syringe NRFit | QEH | 2024-07-13 | 59 |
| K231242 | Perifix FX Catheter; Contiplex FX Catheter | BSO | 2023-09-15 | 137 |
| K223479 | AQUAbase nX | FIP | 2023-08-16 | 271 |
| K220756 | Introcan Safety 2 IV Catheter | FOZ | 2022-06-23 | 100 |
| K220626 | Introcan Safety IV Catheter | FOZ | 2022-05-14 | 71 |
140 earlier clearances. See the full list in Caduvo.
Recalls
509 product recalls in 84 recall events; 228 initiated in the last five years. Most recent: 2026-08-04.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
B.Braun Medical, Inc. is the industry lead sponsor of 2 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT00526058: (H.E.L.P.)Apheresis Therapy to Compare the Reduction of LDL (Low Density Lipoprotein) Cholesterol (Completed, started 2007-08)
- NCT00916643: Low-Density Lipoprotein (LDL) Apheresis Using H.E.L.P. Therapy (Completed, started 1999-12)
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of B.Braun Medical, Inc.'s product codes (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via MRZ)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via MRZ)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via MRZ)
Frequently asked questions
How many FDA 510(k) clearances does B.Braun Medical, Inc. have?
B.Braun Medical, Inc. has 150 FDA 510(k) clearances (first 1993, latest 2026), across 45 product codes in 6 review panels.
How long does FDA take to clear B.Braun Medical, Inc.'s 510(k)s?
The median time from FDA receipt to decision across B.Braun Medical, Inc.'s cleared 510(k)s is 140 days. Since 2017: 188 days, versus 148 days for all cleared 510(k)s in the same product codes.
What devices does B.Braun Medical, Inc. make?
Its most frequent FDA product codes are FPA (Set, Administration, Intravascular, 22); FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days, 12); FRN (Pump, Infusion, 11).
Has B.Braun Medical, Inc. had device recalls?
openFDA lists 509 product recalls in 84 recall events by a recalling firm whose name matches B.Braun Medical, Inc; the most recent began 2026-08-04. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 150 B.Braun Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FPA, B.Braun Medical, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.