SCIg60 Infusion System
FDA 510(k) K173783 · Emed Technologies Corporation
510(k) numberK173783
Submission
- Device name
- SCIg60 Infusion System
- Applicant
- Emed Technologies Corporation
El Dorado Hills, CA, US - Received
- December 13, 2017
- Decision date
- December 14, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PKP – Immunoglobulin G (Igg) Infusion System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5725
- Specialty
- General Hospital
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.
Other 510(k)s with product code PKP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251105 | Tetra (TM-20); Tetra (TM-50)PKP · Traditional | Emed Technologies Corporation | 12/22/2025SE |
| K240148 | SCIg60 Infusion SystemPKP · Special | Emed Technologies Corporation | 02/16/2024SE |
| K230883 | VersaPump Infusion SystemPKP · Traditional | Emed Technologies Corporation | 11/28/2023SE |
| K222087 | SCIg60 Infusion SystemPKP · Traditional | Emed Technologies Corporation | 10/13/2022SE |
| K161906 | SCIg60 InfuserPKP · Traditional | Emed Technologies Corporation | 12/01/2016SE |
| K142319 | SCIg60 Infuser, InfusetPKP · Traditional | Emed Technologies Corporation | 05/14/2015SE |
More from Emed Technologies Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K251105 | Tetra (TM-20); Tetra (TM-50)PKP · Traditional | 12/22/2025SE |
| K240148 | SCIg60 Infusion SystemPKP · Special | 02/16/2024SE |
| K230883 | VersaPump Infusion SystemPKP · Traditional | 11/28/2023SE |
| K213429 | AccuSert Needle InserterKZH · Traditional | 10/20/2022SE |
| K222087 | SCIg60 Infusion SystemPKP · Traditional | 10/13/2022SE |
| K161906 | SCIg60 InfuserPKP · Traditional | 12/01/2016SE |
| K142319 | SCIg60 Infuser, InfusetPKP · Traditional | 05/14/2015SE |
| K140133 | Infuset Flow Control Extension SetFPA · Traditional | 05/15/2014SE |
| K140131 | Sub-Q Subcutaneous Tissue Infusion SetFPA · Special | 04/03/2014SE |
| K123729 | Versarate Flow Rate ControlerFPA · Traditional | 12/21/2012SE |
Questions and answers
When was SCIg60 Infusion System cleared by the FDA?
SCIg60 Infusion System (K173783) received a 510(k) decision of Substantially Equivalent on December 14, 2018, 366 days after the submission was received.
What is the product code of K173783?
The FDA product code is PKP – Immunoglobulin G (Igg) Infusion System, a Class II (moderate risk) device regulated under 21 CFR 880.5725.