Data / Medical devices / United States / Simple Diagnostics

Simple Diagnostics: FDA-registered device maker in Maspeth, NY, United States, 6 510(k) clearances

Name: Simple Diagnostics FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Simple Diagnostics is registered with the FDA (registration 3007384659) in Maspeth, NY, United States. It lists 9 device types. The FDA files 6 510(k) clearances under its listings, the newest dated March 20, 2020. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3007384659
Address: 5208 Grand Ave Suite 201, Maspeth, NY, United States, 11378
Owner or operator: Simple Diagnostics (10028449)
Roles: Complaint file establishment
First device listed: March 10, 2010
Registered through: 2026

Devices it lists

Device	Product code	Class	Role	Source
Bedding, Disposable, Medical	KME	1	Complaint file establishment	accessdata.fda.gov
Holding Chambers, Direct Patient Interface	NVP	2	Complaint file establishment	accessdata.fda.gov
Humidifier, Non-Direct Patient Interface (Home-Use)	KFZ	1	Complaint file establishment	accessdata.fda.gov
Nebulizer (Direct Patient Interface)	CAF	2	Complaint file establishment	accessdata.fda.gov
Needle, Hypodermic, Single Lumen	FMI	2	Complaint file establishment	accessdata.fda.gov
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	FMK	2	Complaint file establishment	accessdata.fda.gov
Syringe, Piston	FMF	2	Complaint file establishment	accessdata.fda.gov
System, Measurement, Blood-Pressure, Non-Invasive	DXN	2	Complaint file establishment	accessdata.fda.gov
System, Test, Blood Glucose, Over The Counter	NBW	2	Complaint file establishment	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
March 20, 2020	K191657	Bioland Blood Glucose Monitoring System	NBW	Substantially Equivalent	Bioland Technology, Ltd.	accessdata.fda.gov
December 29, 2016	K162180	Disposable Insulin Syringe	FMF	Substantially Equivalent	Berpu Medical Technology Co., Ltd.	accessdata.fda.gov
February 25, 2014	K133059	INSULIN PEN NEEDLE	FMI	Substantially Equivalent	Wenzhou Beipu Science & Technology Co., Ltd.	accessdata.fda.gov
December 19, 2013	K123030	COMPRESSOR NEBULIZER MODEL MCN-S600XX	CAF	Substantially Equivalent	Dongguan Aidisy Machinery & Electronic Equipment C	accessdata.fda.gov
January 28, 2011	K101136	FISIO CHAMBER SPACE	NVP	Substantially Equivalent	Koo (Shanghai) Industries Co., Ltd.	accessdata.fda.gov
August 12, 2005	K051703	CLEVER TD-3018A BLOOD PRESSURE MONITOR	DXN	Substantially Equivalent	Taidoc Technology Corporation	accessdata.fda.gov

Compare with other makers

Updated March 20, 2020. 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.