Data / Medical devices / United States / IMPILO, Inc.

IMPILO, Inc.: FDA-registered device maker in Philadelphia, PA, United States, 8 510(k) clearances

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

IMPILO, Inc. is registered with the FDA (registration 3022147580) in Philadelphia, PA, United States. It lists 10 device types. The FDA files 8 510(k) clearances under its listings, the newest dated August 29, 2022. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3022147580
Address: 2275 Bridge street Building 208, unit 110, 300, Philadelphia, PA, United States, 19137
Owner or operator: Impilo Health (10086162)
Roles: Contract manufacturer, Repackager or relabeler
First device listed: October 19, 2022
Registered through: 2026
Brand names listed: Absorbent Sheet 50 mL 3x4, Bioland Blood Pressure Monitor, Bioland Glucose Monitoring System, Fingertip Bandage, Guangdong Transtek Medical Electronics Co, Impilo Collection Kit - 1140, Instant Hot Pack, MICROTAINER BRAND TUBE WITH EDTA and more

Devices it lists

Device	Product code	Class	Role	Source
Blood Specimen Collection Convenience Kit (Excludes Hiv)	PQD	2	Contract manufacturer, Repackager or relabeler	accessdata.fda.gov
Fiber, Medical, Absorbent	FRL	1	Repackager or relabeler	accessdata.fda.gov
Gauze / Sponge,Nonresorbable For External Use	NAB	1	Repackager or relabeler	accessdata.fda.gov
Glucose Oxidase, Glucose	CGA	2	Repackager or relabeler	accessdata.fda.gov
Pack, Hot Or Cold, Disposable	IMD	1	Repackager or relabeler	accessdata.fda.gov
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	FMK	2	Repackager or relabeler	accessdata.fda.gov
System, Measurement, Blood-Pressure, Non-Invasive	DXN	2	Contract manufacturer, Repackager or relabeler	accessdata.fda.gov
System, Test, Blood Glucose, Over The Counter	NBW	2	Contract manufacturer, Repackager or relabeler	accessdata.fda.gov
Tape And Bandage, Adhesive	KGX	1	Repackager or relabeler	accessdata.fda.gov
Tubes, Vials, Systems, Serum Separators, Blood Collection	JKA	2	Repackager or relabeler	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
August 29, 2022	K220676	Blood Pressure Monitor	DXN	Substantially Equivalent	Guangdong Transtek Medical Electronics Co., Ltd.	accessdata.fda.gov
August 12, 2022	K221131	Tasso+	FMK	Substantially Equivalent	Tasso, Inc.	accessdata.fda.gov
September 21, 2020	K201467	Blood Pressure Monitor-Model 2005, 2006-2, 2006-2B	DXN	Substantially Equivalent	Bioland Technology, Ltd.	accessdata.fda.gov
March 20, 2020	K191657	Bioland Blood Glucose Monitoring System	NBW	Substantially Equivalent	Bioland Technology, Ltd.	accessdata.fda.gov
May 2, 2017	K161790	iGlucose Blood Glucose Monitoring System	NBW	Substantially Equivalent	Bionime Corporation	accessdata.fda.gov
February 2, 2016	K160014	iHealth Track Blood Pressure Monitor	DXN	Substantially Equivalent	Andon Health Co, Ltd.	accessdata.fda.gov
June 19, 2013	K131395	TRANSTEK BLOOD PRESSURE MONITOR	DXN	Substantially Equivalent	Guangdong Transtek Medical Electronics Co., Ltd.	accessdata.fda.gov
September 28, 1993	K931368	MICROTAINER BRAND TUBE WITH EDTA	JKA	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic	accessdata.fda.gov

Compare with other makers

Updated August 29, 2022. 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.