Benlan, Inc.
Country not established
- Devices
- 7
- FDA recalls
- 2
At a glance
Market reach
- United States
- FDA recalls
What Benlan, Inc. makes
Benlan, Inc. manufactures medical devices for enteral and oral feeding, including extension sets with T-connectors, pediatric feeding tubes and accessories, oral/enteral syringes, and patient delivery sets. Their portfolio also includes irrigation sets (models 10-3001, 10-3002, 10-4000, 10-4001) and transfer sets (models 10-1227TS, 10-1300TS, 10-1305TS, 10-1306TS). These devices are designed for clinical use in fluid administration and irrigation procedures.
All listed devices fall under FDA Class II regulation and are recorded in the FDA’s 510(k) premarket notification database. The company’s products are based in the United States.
Catalogue
Med-Rx Extension Set With T-Connector Ref K112799
Regimes: 510(k) Registry: 510(k)Med-Rx Oral/Enteral Syringe Ref K131183
Regimes: 510(k) Registry: 510(k)Med-Rx Pediatric Feeding Tubes And Accessories Ref K100700
Regimes: 510(k) Registry: 510(k)Med-Rx Patient Delivery Set Ref K120375
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Med-Rx Extension Sets Ref K990777
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 2 recalls initiated by Benlan, Inc., the earliest on 2011-12-12 and the most recent on 2015-12-11. By recorded status: 2 terminated. The reasons filed fall into these groups: packaging and mechanical integrity. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2015
- 11 Dec 2015 Z-0595-2016 Class II Terminated The product may be packaged with a 5 or 6.5FR tube instead of an 8FR size.
2011
- 12 Dec 2011 Z-1070-2012 Unclassified (pre-2012) Terminated The tip caps may come loose from the syringe, potentially resulting in leakage of medication from the syringe.
Frequently asked questions
How many devices does Benlan, Inc. have in the registry?
The registry currently lists 7 devices for Benlan, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Benlan, Inc.'s devices?
Among its 7 most recently registered devices, Benlan, Inc. has devices listed in FDA 510(k) (7 devices).
What risk classes do Benlan, Inc.'s devices fall under?
Among its 7 most recently registered devices, the classes recorded for Benlan, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Benlan, Inc.?
FDA recall records list 2 recalls initiated by Benlan, Inc., the most recent initiated on 11 Dec 2015. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Benlan, Inc. in the registry?
The most recently registered devices listed for Benlan, Inc. include MED-RX EXTENSION SET WITH T-CONNECTOR, MED-RX ORAL/ENTERAL SYRINGE, MED-RX PEDIATRIC FEEDING TUBES AND ACCESSORIES and MED-RX PATIENT DELIVERY SET.