Fresenius Kabi AG: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Fresenius Kabi AG” (first 2013, latest 2026), across 7 product codes in 4 review panels. Median 510(k) review time under this name: 262 days. Since 2017 the median was 262 days, against 213 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2013 | 1 | 334 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 183 |
| 2017 | 0 | — |
| 2018 | 1 | 255 |
| 2019 | 2 | 62 |
| 2020 | 1 | 193 |
| 2021 | 1 | 29 |
| 2022 | 4 | 413 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 1 | 270 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Fresenius Kabi AG took a median 262 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 213 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| CAC | Apparatus, Autotransfusion | 4 | 4 |
| FRN | Pump, Infusion | 3 | 3 |
| GKT | Separator, Automated, Blood Cell, Diagnostic | 1 | 1 |
| KPE | Container, I.V. | 1 | 1 |
| LHI | Set, I.V. Fluid Transfer | 1 | 1 |
| LKN | Separator, Automated, Blood Cell And Plasma, Therapeutic | 1 | 1 |
| PHC | Infusion Safety Management Software | 1 | 1 |
Review panels
Most recent Fresenius Kabi AG 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K251139 | KabiHelp® Uno; KabiHelp® Advance plus | KPE | 2026-01-09 | 270 |
| K212445 | freeflex+ Transfer Adapter | LHI | 2022-06-01 | 300 |
| K210075 | Vigilant Software Suite Vigilant Master Med | PHC | 2022-03-01 | 413 |
| K210074 | Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link, Agilia Duo, Agilia USB Cable | FRN | 2022-03-01 | 413 |
| K210073 | Agilia VP Infusion System, Agilia VP MC WIFI Infusion Pump, Volumat Lines Administration Sets, Agilia Link, Agilia Duo | FRN | 2022-03-01 | 413 |
| K210089 | CATSmart, Automated Blood Processing Autotransfusion System | CAC | 2021-02-11 | 29 |
| K200530 | AMICUS Separator System | GKT | 2020-09-11 | 193 |
| K192150 | AMICUS Separator System | LKN | 2019-11-13 | 96 |
| K192368 | CATSmart | CAC | 2019-09-27 | 28 |
| K180831 | CATSmart | CAC | 2018-12-10 | 255 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Fresenius Kabi 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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Fresenius Kabi AG (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via FRN)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via FRN)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via FRN)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Fresenius Medical Care Renal Therapies Group, LLC (52 510(k)s)
- Fresenius Medical Care North America (42 510(k)s)
- Fresenius USA, Inc. (38 510(k)s)
- Fresenius Medical Care (7 510(k)s)
- Fresenius Medical Care North America, Design Cente (5 510(k)s)
- Fresenius Hemotechnology, Inc. (3 510(k)s)
- Fresenius Pharma (3 510(k)s)
- Fresenius AG (2 510(k)s)
- Fresenius Kabi (2 510(k)s)
- Fresenius Kabi USA,Llc (2 510(k)s)
- Fresenius Medical Care South Asia Pacific Pty , Ltd. (2 510(k)s)
- Fresenius Kabi Deutschland GmbH (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Fresenius Kabi AG?
FDA lists 12 510(k) clearances under the applicant name “Fresenius Kabi AG” (first 2013, latest 2026), across 7 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Fresenius Kabi AG?
The median time from FDA receipt to decision across 510(k)s cleared under the name Fresenius Kabi AG is 262 days. Since 2017: 262 days, versus 213 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Fresenius Kabi AG?
The most frequent FDA product codes under this applicant name are CAC (Apparatus, Autotransfusion, 4); FRN (Pump, Infusion, 3); GKT (Separator, Automated, Blood Cell, Diagnostic, 1).
Next steps
- See all 12 Fresenius Kabi AG clearances with predicates and recalls
- Run predicate analysis for product code CAC, Fresenius Kabi 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.