Tetra (TM-20); Tetra (TM-50)
FDA 510(k) clearance K251105 · decided 2025-12-22
Clearance details
- K-number
- K251105
- Device name
- Tetra (TM-20); Tetra (TM-50)
- Applicant
- Emed Technologies Corporation
- Decision
- Substantially Equivalent
- Date received
- 2025-04-11
- Decision date
- 2025-12-22
- Days to decision
- 255 days
- Clearance type
- Traditional
- Product code
- PKP
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- El Dorado Hills, CA, US
- Third-party review
- No
- Expedited review
- No
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Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| 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 |
Recalls involving this device
No recalls on record reference this clearance.