Benlan, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Benlan, Inc.” (first 1999, latest 2014), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 169 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 | 143 |
| 2013 | 0 | — |
| 2014 | 1 | 403 |
| 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 |
|---|---|---|---|
| FPA | Set, Administration, Intravascular | 4 | 4 |
| FPD | Tube, Feeding | 1 | 1 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 1 | 1 |
| LJH | System, Irrigation, Urological | 1 | 1 |
Review panels
Most recent Benlan, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K131183 | MED-RX ORAL/ENTERAL SYRINGE | KNT | 2014-06-03 | 403 |
| K120375 | MED-RX PATIENT DELIVERY SET | FPA | 2012-06-28 | 143 |
| K112799 | MED-RX EXTENSION SET WITH T-CONNECTOR | FPA | 2011-12-23 | 87 |
| K100700 | MED-RX PEDIATRIC FEEDING TUBES AND ACCESSORIES | FPD | 2010-12-13 | 276 |
| K102073 | MED-RX TRANSFER SET, MODELS 10-1227TS, 10-1300TS, 10-1305TS AND 10-1306TS | FPA | 2010-11-08 | 108 |
| K010607 | MED-RX IRRIGATION SET, MODEL 10-3001, 10-3002, 10-4000, 10-4001 | LJH | 2001-11-28 | 272 |
| K990777 | MED-RX EXTENSION SETS | FPA | 1999-08-25 | 169 |
Recalls
2 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2015-12-11.
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 Benlan, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Benlan, Inc.” (first 1999, latest 2014), across 4 product codes in 2 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 Benlan, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Benlan, Inc. is 169 days.
Which FDA product codes appear under Benlan, Inc.?
The most frequent FDA product codes under this applicant name are FPA (Set, Administration, Intravascular, 4); FPD (Tube, Feeding, 1); KNT (Tubes, Gastrointestinal (And Accessories), 1).
Next steps
- See all 7 Benlan, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FPA, Benlan, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.