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Med-Linket Corp: FDA-registered device maker in Alhambra, CA, United States, 13 510(k) clearances

Name: Med-Linket Corp FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Med-Linket Corp is registered with the FDA (registration 3013426279) in Alhambra, CA, United States. It lists 16 device types. The FDA files 13 510(k) clearances under its listings, the newest dated January 19, 2023. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3013426279
Address: 245 East Main Street, Suite 115, Alhambra, CA, United States, 91801
Owner or operator: MED-LINKET CORP (10054780)
Roles: Manufacturer
First device listed: September 3, 2024
Registered through: 2026
Brand names listed: Adult SpO2 Finger Sensor, Disposable Gas Sampling Line, Disposable Non-invasive EEG Sensor, Disposable Pressure Infusion Bag;, Hylink Disposable Blood Pressure Cuff, Incontinence probe, Interconnect tube, MED-LINKET Disposable Spo2 Sensor S0005J-S S0005K-S S0005L-L S0005M-L S0005N-L and more

Devices it lists

Device	Product code	Class	Role	Source
Blood Pressure Cuff	DXQ	2	Manufacturer	accessdata.fda.gov
Cable, Electrode	IKD	2	Manufacturer	accessdata.fda.gov
Cable, Transducer And Electrode, Patient, (Including Connector)	DSA	2	Manufacturer	accessdata.fda.gov
Cannula, Nasal, Oxygen	CAT	1	Manufacturer	accessdata.fda.gov
Continuous Measurement Thermometer	FLL	2	Manufacturer	accessdata.fda.gov
Drain, Tee (Water Trap)	BYH	1	Manufacturer	accessdata.fda.gov
Dress, Surgical	FYE	1	Manufacturer	accessdata.fda.gov
Electrode, Cutaneous	GXY	2	Manufacturer	accessdata.fda.gov
Electrode, Electrocardiograph	DRX	2	Manufacturer	accessdata.fda.gov
Infusor, Pressure, For I.V. Bags	KZD	1	Manufacturer	accessdata.fda.gov
Oximeter	DQA	2	Manufacturer	accessdata.fda.gov
Perineometer	HIR	2	Manufacturer	accessdata.fda.gov
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	HOY	1	Manufacturer	accessdata.fda.gov
Stimulator, Electrical, Non-Implantable, For Incontinence	KPI	2	Manufacturer	accessdata.fda.gov
System, Measurement, Blood-Pressure, Non-Invasive	DXN	2	Manufacturer	accessdata.fda.gov
System, Pressure Measurement, Intermittent	JFC	1	Manufacturer	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
January 19, 2023	K220448	Disposable Non-invasive EEG Sensor	GXY	Substantially Equivalent	Shenzhen Med-Link Electronics Tech Co., Ltd.	accessdata.fda.gov
June 28, 2022	K220447	Med-link Disposable ECG Cable and Leadwires	DSA	Substantially Equivalent	Shenzhen Med-Link Electronics Tech Co., Ltd.	accessdata.fda.gov
May 20, 2022	K212752	Med-link Pulse Oximeter	DQA	Substantially Equivalent	Shenzhen Med-Link Electronics Tech Co., Ltd.	accessdata.fda.gov
September 17, 2021	K210441	Incontinence Probe	KPI	Substantially Equivalent	Shenzhen Med-Link Electronics Tech Co., Ltd.	accessdata.fda.gov
March 1, 2021	K202743	Med-Link Temp-pulse Oximeter	DQA	Substantially Equivalent	Shenzhen Med-Link Electronics Tech Co., Ltd.	accessdata.fda.gov
August 25, 2020	K193338	Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes	FLL	Substantially Equivalent	Shenzhen Med-Link Electronics Tech Co., Ltd.	accessdata.fda.gov
August 2, 2019	K181154	Med-link Wrist Digital Blood Pressure Monitor, Med-link Upper Arm Digital Blood Pressure Monitor	DXN	Substantially Equivalent	Shenzhen Med-Link Electronics Tech Co., Ltd.	accessdata.fda.gov
June 18, 2019	K182667	Med-link Temperature Probes	FLL	Substantially Equivalent	Shenzhen Med-Link Electronics Tech Co., Ltd.	accessdata.fda.gov
August 2, 2018	K173869	Med-link Reusable Blood Pressure Cuff	DXQ	Substantially Equivalent	Shenzhen Med-Link Electronics Tech Co., Ltd.	accessdata.fda.gov
November 28, 2016	K160530	Med-link Reusable Blood Pressure Cuff, Med-link Disposable Blood Pressure Cuff	DXQ	Substantially Equivalent	Shenzhen Med-Link Electronics Tech Co., Ltd.	accessdata.fda.gov
March 21, 2013	K113727	SHENZHEN MED-LINK PULSE OXIMETER PROBE	DQA	Substantially Equivalent	Shenzhen Med-Link Electronics Tech Co., Ltd.	accessdata.fda.gov
January 19, 2012	K120010	CABLE/ LEAD-WIRE (ECG, EKG, SPO2 AND INVASIVE BLOOD PRESSURE)	DSA	Substantially Equivalent	Shenzhen Med-Link Electronics Tech Co., Ltd.	accessdata.fda.gov
June 10, 2009	K083010	SHENZHEN MED-LINKET ADULT FINGER CLIP SPO2 SENSOR, SHENZHEN MED-LINKET ADULT SILICONE SOFT TIP SPO2 SENSOR	DQA	Substantially Equivalent	Shenzhen Med-Link Electronics Tech Co., Ltd.	accessdata.fda.gov

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Updated January 19, 2023. 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.