Chf Solutions, Inc.: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Chf Solutions, Inc.” (first 2002, latest 2020), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 76 days. 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 |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 147 |
| 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 Chf Solutions, Inc. took a median 147 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 200 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KDI | Dialyzer, High Permeability With Or Without Sealed Dialysate System | 11 | 11 |
| NQJ | Catheter, Hemodialysis, Non-Implanted, Ultrafiltration, For Peripheral Use | 2 | 2 |
Review panels
Most recent Chf Solutions, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K192756 | Aquadex FlexFlow System 2.0 | KDI | 2020-02-24 | 147 |
| K071854 | AQUADEX FLEXFLOW SYSTEM | KDI | 2007-09-07 | 64 |
| K070512 | MODIFICATION TO AQUADEX FLEXFLOW SYSTEM | KDI | 2007-04-27 | 64 |
| K062922 | MODIFICATION TO AQUADEX FLEXFLOW SYSTEM | KDI | 2006-12-13 | 76 |
| K060008 | AQUADEX FLEXFLOW SYSTEM | KDI | 2006-02-02 | 30 |
| K050609 | AQUADEX SYSTEM | KDI | 2005-11-09 | 244 |
| K041791 | 5.2F DUAL LUMEN EXTENDED LENGTH CATHETER (DELC) | NQJ | 2004-09-10 | 70 |
| K040489 | AQUADEX SYSTEM 100, MODEL A1100 | KDI | 2004-04-27 | 61 |
| K031689 | DUAL LUMEN EXTENDED LENGTH CATHETER (DELC) | NQJ | 2003-12-23 | 204 |
| K023874 | SYSTEM 100 ULTRAFILTRATION CATHETER | KDI | 2003-11-20 | 364 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Chf Solutions, Inc..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Chf Solutions, Inc.?
FDA lists 13 510(k) clearances under the applicant name “Chf Solutions, Inc.” (first 2002, latest 2020), across 2 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 Chf Solutions, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Chf Solutions, Inc. is 76 days.
Which FDA product codes appear under Chf Solutions, Inc.?
The most frequent FDA product codes under this applicant name are KDI (Dialyzer, High Permeability With Or Without Sealed Dialysate System, 11); NQJ (Catheter, Hemodialysis, Non-Implanted, Ultrafiltration, For Peripheral Use, 2).
Next steps
- See all 13 Chf Solutions, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KDI, Chf Solutions, Inc.'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.