Mallya Injection Pen Adapter (Mallya® for Solostar®)
FDA 510(k) clearance K222689 · decided 2022-12-05
Clearance details
- K-number
- K222689
- Device name
- Mallya Injection Pen Adapter (Mallya® for Solostar®)
- Applicant
- Biocorp Production
- Decision
- Substantially Equivalent
- Date received
- 2022-09-06
- Decision date
- 2022-12-05
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- QOG
- Device class
- 2
- Regulation number
- 880.5860
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Issoire, FR
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SmartPilot YpsoMate NS-A2.25 (K243901) | Ypsomed AG | 2025-08-28 |
| MallyaG Injection Pen Adapter (MallyaG) (K251500) | Biocorp Production | 2025-06-09 |
| MallyaD injection pen adapter (MallyaD) (K250555) | Biocorp Production | 2025-03-27 |
| INSULCLOCK® v2.0 PRO (K241803) | Insulcloud S.L. | 2024-08-22 |
| SoloSmart Injection Pen Adapter (SoloSmart®) (K231820) | Biocorp Production | 2024-01-12 |
| Tempo Smart Button (K212217) | Eli Lilly and Company | 2022-09-16 |
Recalls involving this device
No recalls on record reference this clearance.