Acucera, Inc.
South KoreaFDA applicant, unverified
- Devices
- 2
What Acucera, Inc. makes
Acucera, Inc. manufactures insulin delivery systems, including the ZIRACE, a portable insulin pump designed for continuous subcutaneous insulin infusion, and ZIRBLANK-PS and ZIRBLANK-FS, which are disposable insulin pump components for refilling and maintenance. These devices are intended for managing diabetes by automating insulin administration.
The company’s products fall under FDA Class II medical devices and are listed via the 510(k) pathway, indicating they undergo regulatory review for safety and performance. The manufacturer is based in the United States.
Catalogue
Zirace Ref K051501
Regimes: 510(k) Registry: 510(k)Zirblank-Ps And Zirblank-Fs Ref K070045
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Acucera, Inc. have in the registry?
The registry currently lists 2 devices for Acucera, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Acucera, Inc.'s devices?
Among its 2 most recently registered devices, Acucera, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Acucera, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Acucera, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Acucera, Inc. in the registry?
The most recently registered devices listed for Acucera, Inc. include ZIRACE and ZIRBLANK-PS AND ZIRBLANK-FS.