Fenwal, Inc.: FDA filings under this applicant name
FDA lists 3 510(k) clearances under the applicant name “Fenwal, Inc.” (first 2008, latest 2014), plus 1 PMA decision, across 3 product codes in 3 review panels. Median 510(k) review time under this name: 96 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 | 1 | 279 |
| 2013 | 0 | — |
| 2014 | 1 | 50 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LKN | Separator, Automated, Blood Cell And Plasma, Therapeutic | 2 | 2 |
| BRZ | Set, Blood Transfusion | 1 | 1 |
| LMN | Ceramics, Calcium Triphosphate/Hydroxypatite, Non-Load Bearing Uses | 1 | 0 |
Review panels
Most recent Fenwal, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K141019 | AMICUS SEPARATOR SYSTEM/ AMICUS SEPERATOR SYSTEM;REFURBISHED | LKN | 2014-06-10 | 50 |
| K111702 | AMICUS SEPARATOR SYSTEM- USE IN THERAPEUTIC PLASMA EXCHANGE AND FILTER SET FOR AMICUS TPE | LKN | 2012-03-22 | 279 |
| K073339 | BLOOD COMPONENT RECIPIENT SET WITH STANDARD SIZE FILTER AND INFUSION SET WITH SIDE ARM LUER CONNECTOR | BRZ | 2008-03-03 | 96 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P820032 | PMA | PLASMA SEPARATION SYSTEM | 1983-10-07 |
Recalls
10 product recalls in 6 recall events; 2 initiated in the last five years. Most recent: 2023-02-14.
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 Fenwal, Inc. is the lead sponsor of 3 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT06122935: Evaluation of the Aurora Xi New Nomogram Software 2.0 (Completed, started 2023-11-27)
- NCT02372877: Evaluation of the AMICUS RBCx System in Sickle Cell Patients (Completed, started 2015-05)
- NCT01210716: Evaluation of Therapeutic Plasma Exchange (TPE) Procedure Using the AMICUS Device (Completed, started 2010-09)
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.
- Fenwal Laboratories (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Fenwal, Inc.?
FDA lists 3 510(k) clearances under the applicant name “Fenwal, Inc.” (first 2008, latest 2014), plus 1 PMA decision, across 3 product codes in 3 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 Fenwal, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Fenwal, Inc. is 96 days.
Which FDA product codes appear under Fenwal, Inc.?
The most frequent FDA product codes under this applicant name are LKN (Separator, Automated, Blood Cell And Plasma, Therapeutic, 2); BRZ (Set, Blood Transfusion, 1); LMN (Ceramics, Calcium Triphosphate/Hydroxypatite, Non-Load Bearing Uses, 1).
Next steps
- See all 3 Fenwal, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LKN, Fenwal, 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.