510(k) K251105
K251105 is an FDA 510(k) premarket notification submitted by Emed Technologies Corporation for the device "Tetra (TM-20); Tetra (TM-50)". The FDA issued a decision of Substantially Equivalent on December 22, 2025. The device falls under product code PKP (Immunoglobulin G (Igg) Infusion System), a Class II device regulated under 21 CFR 880.5725. Emed Technologies Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 22, 2025
- Date Received
- April 11, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Immunoglobulin G (Igg) Infusion System
- Device Class
- Class II
- Regulation Number
- 880.5725
- Review Panel
- HO
- Submission Type
An Immunoglobulin G (IgG) Infusion System is a prescription device intended for subcutaneous delivery of Immunoglobulin G (IgG) in accordance with the FDA approved labeling.