Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2523167

FEI Number

2523167

Entity Name

EMED TECHNOLOGIES CORPORATION

City/State/Country

EL DORADO HILLS, CA, US

Establishment Address

1262 Hawks Flight Ct Ste 200, EL DORADO HILLS, CA 95762, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

EMED Technologies Corporation (Owner Number: 2523167)

Owner / Operator Contact Address

1262 Hawks Flight Court, Suite 200, El Dorado Hills, CA 95762, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K020530

PMA Number

N/A

All Registered Proprietary Names

SCIg60 Infusion System VersaRate Flow Rate Controller SCIg60 Infuser AccuSert SCIg60 Infusion System SUB-Q SAF-Q OPTflow SCIg60 Infusion System Infuset FLO VersaPump Infuser VersaPump Infusion System SCIg Set SUB-Q SUB SAF-Q

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PKP	Immunoglobulin G (Igg) Infusion System	General Hospital	Class 2	880.5725	2022-10-21
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2013-01-10
PKP	Immunoglobulin G (Igg) Infusion System	General Hospital	Class 2	880.5725	2025-01-08
KZH	Introducer, Syringe Needle	General Hospital	Class 2	880.6920	2022-10-21
PKP	Immunoglobulin G (Igg) Infusion System	General Hospital	Class 2	880.5725	2015-05-14
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2015-01-23
PKP	Immunoglobulin G (Igg) Infusion System	General Hospital	Class 2	880.5725	2021-11-12
FPK	Tubing, Fluid Delivery	General Hospital	Class 2	880.5440	2010-05-10
PKP	Immunoglobulin G (Igg) Infusion System	General Hospital	Class 2	880.5725	2023-12-14
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2008-05-19

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

EMED Technologies Corporation

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K221518	Np Medical	NP Medical nCompass Extension Set with Stabilizing Base	2022-11-03
K953474	Medikmark, Inc.	IV START KIT	1995-10-02
K972493	Nipro Medical Corp.	NIPRO DISPOSABLE SOLUTION INFUSION SET	1997-09-18
K982672	Baxter Healthcare Corp	COLLEAGUE PUMP SYRINGE ADAPTER SET	1998-09-04
K143446	Roche Diagnostics GmbH	Accu-Chek FlexLink Plus infusion set	2015-08-13

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0010-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
Z-0011-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24
Z-0012-2013	Baxter Healthcare Corp. Rt.	2	Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve Drip Chamber); a sterile Rx IV fluid pathway device. Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.
Z-0012-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24
Z-0013-2013	Baxter Healthcare Corp. Rt.	2	Baxter Interlink System Buretrol Solution Set, 117" (3.0 m), with 150 mL Burette (Ball-Valve Drip Chamber) (Non-DEHP); a sterile Rx IV fluid pathway device; Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.

Similar Registrations

Registration Number	Establishment Name	Location
3018229072	INNOVATIVE HEALTH SCIENCES	Chester, NY, US
3007428065	DIMCOGRAY CORP. DBA DG MEDICAL	Centerville, OH, US
3024122953	KORU MEDICAL SYSTEMS, INC.	Mahwah, NJ, US
3003927385	JDI ELECTRONICS FACTORY	Dongguan Guangdong, CN
3008132411	Sterigenics Shanghai E Beam Ltd.	Shanghai, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2523167. Last updated year: 2026. Please use registration number 2523167 when referencing this establishment in official correspondence.