PKP
7 FDA 510(k) clearances · Product code
243 daysmedian time to decision
366 days90th percentile
7clearances measured
FDA profile
- Official device name
- Immunoglobulin G (Igg) Infusion System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5725
- Medical specialty
- General Hospital
- FDA definition
- 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.
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| Record | Firm | Date |
|---|---|---|
| Tetra (TM-20); Tetra (TM-50) (K251105) | Emed Technologies Corporation | 2025-12-22 |
| SCIg60 Infusion System (K240148) | Emed Technologies Corporation | 2024-02-16 |
| VersaPump Infusion System (K230883) | Emed Technologies Corporation | 2023-11-28 |
| SCIg60 Infusion System (K222087) | Emed Technologies Corporation | 2022-10-13 |
| SCIg60 Infusion System (K173783) | Emed Technologies Corporation | 2018-12-14 |
| SCIg60 Infuser (K161906) | Emed Technologies Corporation | 2016-12-01 |
| SCIg60 Infuser, Infuset (K142319) | Emed Technologies Corporation | 2015-05-14 |
Track PKP automatically
Every clearance here is in the API, with alerts when new ones post.