Data / Medical devices / United States / Mannkind Corporation
Mannkind Corporation: FDA-registered device maker in Danbury, CT, United States, 2 510(k) clearances
Mannkind Corporation is registered with the FDA (registration 3005340341) in Danbury, CT, United States. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated February 23, 2011. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005340341
- Address
- 1 Casper St, Danbury, CT, United States, 06810
- Owner or operator
- MannKind Corporation (10056720)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- May 12, 2022
- Registered through
- 2026
- Brand names listed
- BluHale PRO, V-GO DISPOSABLE INSULIN DELIVERY DEVICE, MODEL# V-GO 20, V-GO 30, V-GO40, V-GO INSULIN DELIVERY SYSTEM
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Pump, Infusion, Insulin | LZG | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Set, Administration, Intravascular | FPA | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Transducer, Gas Pressure, Differential | BYR | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 23, 2011 | K103825 | V-GO INSULIN DELIVERY SYSTEM | LZG | Substantially Equivalent | Valeritas, Inc. | accessdata.fda.gov |
| December 1, 2010 | K100504 | V-GO DISPOSABLE INSULIN DELIVERY DEVICE, MODEL# V-GO 20, V-GO 30, V-GO40 | LZG | Substantially Equivalent | Valeritas, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Set, Administration, Intravascular
- All makers of Pump, Infusion, Insulin
- All makers of Transducer, Gas Pressure, Differential
Updated February 23, 2011. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.