Data / Medical devices / United States / Emed Technologies Corporation
Emed Technologies Corporation: FDA-registered device maker in El Dorado Hills, CA, United States, 13 510(k) clearances
Emed Technologies Corporation is registered with the FDA (registration 2523167) in El Dorado Hills, CA, United States. It lists 5 device types. The FDA files 13 510(k) clearances under its listings, the newest dated December 22, 2025. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 2523167
- Address
- 1262 Hawks Flight Ct Ste 200, El Dorado Hills, CA, United States, 95762
- Owner or operator
- EMED Technologies Corporation (2523167)
- Roles
- Specification developer
- First device listed
- May 19, 2008
- Registered through
- 2027
- Brand names listed
- AccuSert, FLO, Infuset, Infuset Flow Control Extension Set, Infuset Flow Control Infusion Set, OPTflow, SAF-Q, SCIg Set and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Immunoglobulin G (Igg) Infusion System | PKP | 2 | Specification developer | accessdata.fda.gov |
| Introducer, Syringe Needle | KZH | 2 | Specification developer | accessdata.fda.gov |
| Pump, Infusion | FRN | 2 | Specification developer | accessdata.fda.gov |
| Set, Administration, Intravascular | FPA | 2 | Specification developer | accessdata.fda.gov |
| Tubing, Fluid Delivery | FPK | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 22, 2025 | K251105 | Tetra (TM-20); Tetra (TM-50) | PKP | Substantially Equivalent | Emed Technologies Corporation | accessdata.fda.gov |
| February 16, 2024 | K240148 | SCIg60 Infusion System | PKP | Substantially Equivalent | Emed Technologies Corporation | accessdata.fda.gov |
| November 28, 2023 | K230883 | VersaPump Infusion System | PKP | Substantially Equivalent | Emed Technologies Corporation | accessdata.fda.gov |
| October 20, 2022 | K213429 | AccuSert Needle Inserter | KZH | Substantially Equivalent | Emed Technologies Corporation | accessdata.fda.gov |
| October 13, 2022 | K222087 | SCIg60 Infusion System | PKP | Substantially Equivalent | Emed Technologies Corporation | accessdata.fda.gov |
| December 14, 2018 | K173783 | SCIg60 Infusion System | PKP | Substantially Equivalent | Emed Technologies Corporation | accessdata.fda.gov |
| December 1, 2016 | K161906 | SCIg60 Infuser | PKP | Substantially Equivalent | Emed Technologies Corporation | accessdata.fda.gov |
| May 14, 2015 | K142319 | SCIg60 Infuser, Infuset | PKP | Substantially Equivalent | Emed Technologies Corporation | accessdata.fda.gov |
| May 15, 2014 | K140133 | INFUSET FLOW CONTROL EXTENSION SET | FPA | Substantially Equivalent | Emed Technologies Corporation | accessdata.fda.gov |
| April 3, 2014 | K140131 | SUB-Q SUBCUTANEOUS TISSUE INFUSION SET | FPA | Substantially Equivalent | Emed Technologies Corporation | accessdata.fda.gov |
| December 21, 2012 | K123729 | VERSARATE FLOW RATE CONTROLER | FPA | Substantially Equivalent | Emed Technologies Corporation | accessdata.fda.gov |
| April 29, 2002 | K020530 | EVANS SUB-Q, MODEL MC4206 | FPA | Substantially Equivalent | Evans Medical, Inc. | accessdata.fda.gov |
| January 28, 1994 | K935642 | EVANS MEDICAL EXTENSION SETS | FPK | Substantially Equivalent | Evans Medical, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Introducer, Syringe Needle
- All makers of Set, Administration, Intravascular
- All makers of Immunoglobulin G (Igg) Infusion System
- All makers of Pump, Infusion
- All makers of Tubing, Fluid Delivery
Updated December 22, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.