B. Braun: FDA 510(k) clearances across all its applicant names
FDA lists 597 510(k) clearances, 1 PMA and 0 De Novo decision across the 23 applicant names Caduvo groups under B. Braun, first 1976, latest 2026. Median 510(k) review time across these names: 90 days. Since 2017 the median was 167 days, against 110 days for all cleared 510(k)s in the same product codes. Groups are curated by Caduvo from public sources listed below; FDA does not group applicants. Counts include filings made before an acquisition, and can include older filings by a business that was later sold when FDA records them under the same applicant name; see the notes on this page.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 14 | 102 |
| 2013 | 14 | 105 |
| 2014 | 16 | 90 |
| 2015 | 17 | 151 |
| 2016 | 15 | 198 |
| 2017 | 14 | 184 |
| 2018 | 13 | 243 |
| 2019 | 7 | 146 |
| 2020 | 12 | 153 |
| 2021 | 6 | 180 |
| 2022 | 7 | 100 |
| 2023 | 4 | 173 |
| 2024 | 4 | 106 |
| 2025 | 2 | 254 |
| 2026 | 2 | 246 |
The 23 FDA applicant names in this group
| Applicant name | 510(k) clearances | PMA | De Novo | Years |
|---|---|---|---|---|
| Aesculap, Inc. | 218 | 0 | 0 | 1991–2025 |
| B.Braun Medical, Inc. | 150 | 0 | 0 | 1993–2026 |
| Aesculap Implant Systems, LLC | 51 | 0 | 0 | 2007–2022 |
| Burron Medical Products, Inc. | 41 | 0 | 0 | 1979–1987 |
| B. Braun of America, Inc. | 19 | 0 | 0 | 1991–2000 |
| Aesculap Implant System, Inc. | 18 | 0 | 0 | 2007–2014 |
| Aesculap Instruments Corp. | 13 | 0 | 0 | 1977–1990 |
| American Mcgaw | 13 | 0 | 0 | 1981–1985 |
| B. Braun Instruments | 13 | 0 | 0 | 1976–1976 |
| Mcgaw, Inc. | 13 | 0 | 0 | 1991–1997 |
| Burron Medical, Inc. | 9 | 0 | 0 | 1988–1991 |
| Aesculap-Meditec North America | 6 | 0 | 0 | 1998–2000 |
| B. Braun Avitum AG | 5 | 1 | 0 | 2010–2017 |
| B.Braun Melsungen AG | 5 | 0 | 0 | 2011–2017 |
| Aesculap Implants Systems, LLC | 4 | 0 | 0 | 2015–2023 |
| Aesculap-Meditec GmbH | 3 | 0 | 0 | 1997–1999 |
| B. Braun Interventional Systems, Inc. | 3 | 0 | 0 | 2013–2017 |
| B. Braun Medizintechnologie GmbH | 3 | 0 | 0 | 2006–2008 |
| Mcgaw Laboratories | 3 | 0 | 0 | 1976–1978 |
| B. Braun Medical AG | 2 | 0 | 0 | 1997–1998 |
| B. Braun Vena-Tech | 2 | 0 | 0 | 1992–1993 |
| B. Braun/Mcgaw | 2 | 0 | 0 | 1999–2000 |
| B. Braun Melsugen AG | 1 | 0 | 0 | 2020–2020 |
Review time against the same product codes
Since 2017, 510(k)s cleared under these names took a median 167 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 110 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FPA | Set, Administration, Intravascular | 37 | 37 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 20 | 20 |
| FRN | Pump, Infusion | 18 | 18 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 18 | 18 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 18 | 18 |
| LHI | Set, I.V. Fluid Transfer | 16 | 16 |
| NKB | Thoracolumbosacral Pedicle Screw System | 15 | 15 |
| GCJ | Laparoscope, General & Plastic Surgery | 14 | 14 |
| JXG | Shunt, Central Nervous System And Components | 13 | 13 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 13 | 13 |
Plus 166 more product codes.
Review panels
- General Hospital (177)
- Orthopedic (124)
- General and Plastic Surgery (102)
- Neurology (67)
- Cardiovascular (42)
- Gastroenterology and Urology (38)
- Anesthesiology (31)
- Dental (5)
- Obstetrics and Gynecology (4)
- Radiology (3)
- Ophthalmic (2)
- Physical Medicine (1)
Most recent B. Braun 510(k) clearances
| 510(k) | Device | Applicant name | Product code | Decision date | Review days |
|---|---|---|---|---|---|
| K254111 | Irrigation/Urology Sets | B.Braun Medical, Inc. | LJH | 2026-09-10 | 265 |
| K253235 | Introcan Safety® Deep Access XL IV Catheter | B.Braun Medical, Inc. | FOZ | 2026-05-15 | 228 |
| K243392 | Infusomat® Space Volumetric Infusion Pump Administration Sets | B.Braun Medical, Inc. | FPA | 2025-07-24 | 266 |
| K242762 | Aesculap Aicon® Series Container System | Aesculap, Inc. | KCT | 2025-05-13 | 243 |
| K242003 | XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set | Aesculap, Inc. | JXG | 2024-12-16 | 160 |
| K240578 | VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter System | B.Braun Medical, Inc. | DTK | 2024-07-31 | 152 |
| K241845 | Introcan Safety® 2 IV Catheter | B.Braun Medical, Inc. | FOZ | 2024-07-26 | 30 |
| K241385 | Omnifix Syringe NRFit | B.Braun Medical, Inc. | QEH | 2024-07-13 | 59 |
| K231242 | Perifix FX Catheter; Contiplex FX Catheter | B.Braun Medical, Inc. | BSO | 2023-09-15 | 137 |
| K223479 | AQUAbase nX | B.Braun Medical, Inc. | FIP | 2023-08-16 | 271 |
587 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P940016 | PMA | H.E.L.P. SYSTEM | 1997-09-19 |
Recalls
630 product recalls in 154 recall events under these names; 253 initiated in the last five years.
Recalling firms are matched to the applicant names above by name only, so recalls filed under other names are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
How this group is built
Groups are curated by Caduvo from public sources listed below; FDA does not group applicants. Counts include filings made before an acquisition, and can include older filings by a business that was later sold when FDA records them under the same applicant name; see the notes on this page.
Family-owned B. Braun Melsungen AG. Aesculap is a B. Braun company; Burron Medical and McGaw (1997) were acquired. Includes filings made before each acquisition. McGaw had earlier periods under other owners (American Hospital Supply, Kendall); Kendall McGaw names are left out.
Sources
Frequently asked questions
How many FDA 510(k) clearances are listed across B. Braun's applicant names?
FDA lists 597 510(k) clearances, 1 PMA and 0 De Novo decision across the 23 applicant names Caduvo groups under B. Braun, first 1976, latest 2026. FDA records each applicant name separately; Caduvo adds up the names listed on this page.
Which FDA applicant names does B. Braun file under?
The names with the most 510(k) clearances in this group are Aesculap, Inc. (218); B.Braun Medical, Inc. (150); Aesculap Implant Systems, LLC (51); Burron Medical Products, Inc. (41); B. Braun of America, Inc. (19). The full list of 23 names is on this page.
How long does FDA take to clear B. Braun 510(k)s?
The median time from FDA receipt to decision across 510(k)s cleared under these names is 90 days. Since 2017 the median was 167 days, against 110 days for all cleared 510(k)s in the same product codes.
Does the B. Braun count include acquired companies?
Yes. A group includes filings an acquired business made under its own name, including before the acquisition. Businesses that were sold are left out, and names whose ownership is unclear are not included. FDA does not group applicants; the sources for each grouping are listed on this page.
Next steps
- See all 597 B. Braun clearances with predicates and recalls
- Run predicate analysis for product code FPA, B. Braun's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls). Applicant names are matched exactly, with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this grouping or data.
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