B. Braun Avitum AG: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “B. Braun Avitum AG” (first 2010, latest 2017), plus 1 PMA decision, across 3 product codes in 1 review panel. Median 510(k) review time under this name: 264 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under B. Braun, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 449 |
| 2017 | 1 | 165 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name B. Braun Avitum AG took a median 165 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 211 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KDI | Dialyzer, High Permeability With Or Without Sealed Dialysate System | 4 | 4 |
| KPO | Dialysate Concentrate For Hemodialysis (Liquid Or Powder) | 1 | 1 |
| MMY | Lipoprotein, Low Density, Removal | 1 | 0 |
Review panels
Most recent B. Braun Avitum AG 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K170574 | Diacap Pro Dialyzer | KDI | 2017-08-11 | 165 |
| K143482 | xevonta dialyzer | KDI | 2016-03-01 | 449 |
| K102194 | SOLCART B | KPO | 2011-04-25 | 264 |
| K100334 | DIACAP POLYSULFONE HIFLO 23 HEMODILAYZER , MODEL 72036811 | KDI | 2010-04-22 | 76 |
| K083460 | DIALOG WITH ADIMEA OPTION | KDI | 2010-02-18 | 454 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P940016 | PMA | H.E.L.P. SYSTEM | 1997-09-19 |
Recalls
openFDA lists no recalls under a recalling firm named B. Braun Avitum AG.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named B. Braun Avitum AG is the lead sponsor of 4 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT06376968: Prospective, Multicentre, Randomized, Controlled, Cross-over Study on the Safety and Performance of the Biologic Fusion Option of DialogiQ Compared to Haemodialysis Without Biologic Fusion in Hypotension Prone Patients on Maintenance Haemodialysis (Recruiting, started 2024-04-22)
- NCT02964429: Determination In-vivo KUF for Diacap Pro Hemodialyser (Completed, started 2016-11-14)
- NCT01840683: HELP Therapy for Dry AMD (Completed, started 2013-05)
- NCT01111266: Determination of in Vivo Ultrafiltration Coefficient (KUF) in Patients With Chronic Kidney Disease (CKD) (Completed, started 2010-03)
Frequently asked questions
How many FDA 510(k) clearances are listed under B. Braun Avitum AG?
FDA lists 5 510(k) clearances under the applicant name “B. Braun Avitum AG” (first 2010, latest 2017), plus 1 PMA decision, across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by B. Braun Avitum AG?
The median time from FDA receipt to decision across 510(k)s cleared under the name B. Braun Avitum AG is 264 days.
Which FDA product codes appear under B. Braun Avitum AG?
The most frequent FDA product codes under this applicant name are KDI (Dialyzer, High Permeability With Or Without Sealed Dialysate System, 4); KPO (Dialysate Concentrate For Hemodialysis (Liquid Or Powder), 1); MMY (Lipoprotein, Low Density, Removal, 1).
Next steps
- See all 5 B. Braun Avitum AG clearances with predicates and recalls
- Run predicate analysis for product code KDI, B. Braun Avitum AG's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.