FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Tetra (TM-20); Tetra (TM-50)
K Number: K251105
·
Decision Dec 22, 2025
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
6
Applicant Total
11
Review Days
255
Basic Information
- Device Name
- Tetra (TM-20); Tetra (TM-50)
- K Number
- K251105
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5725
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Emed Technologies Corporation
- Date Received
- April 11, 2025
- Decision Date
- December 22, 2025
- Product Code
- PKP
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| PKP | Immunoglobulin G (Igg) Infusion System | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (PKP), ordered by most recent decision date.
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Other Clearances by Emed Technologies Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K240148 | SCIg60 Infusion System | Feb 16, 2024 | Substantially Equivalent |
| K230883 | VersaPump Infusion System | Nov 28, 2023 | Substantially Equivalent |
| K213429 | AccuSert Needle Inserter | Oct 20, 2022 | Substantially Equivalent |
| K222087 | SCIg60 Infusion System | Oct 13, 2022 | Substantially Equivalent |
| K173783 | SCIg60 Infusion System | Dec 14, 2018 | Substantially Equivalent |
| K161906 | SCIg60 Infuser | Dec 1, 2016 | Substantially Equivalent |
| K142319 | SCIg60 Infuser, Infuset | May 14, 2015 | Substantially Equivalent |
| K140133 | INFUSET FLOW CONTROL EXTENSION SET | May 15, 2014 | Substantially Equivalent |
| K140131 | SUB-Q SUBCUTANEOUS TISSUE INFUSION SET | Apr 3, 2014 | Substantially Equivalent |
| K123729 | VERSARATE FLOW RATE CONTROLER | Dec 21, 2012 | Substantially Equivalent |