Data / Medical devices / United States / Alleva Medical Devices

Alleva Medical Devices: FDA-registered device maker in Pomona, CA, United States, 6 510(k) clearances

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

Alleva Medical Devices is registered with the FDA (registration 3021767551) in Pomona, CA, United States. It lists 7 device types. The FDA files 6 510(k) clearances under its listings, the newest dated March 8, 2023. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3021767551
Address: 3101 Pomona Blvd, Pomona, CA, United States, 91768
Owner or operator: Alleva Medical Devices (10084505)
Roles: Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer
First device listed: March 1, 2022
Registered through: 2027
Brand names listed: 1000mL "Bag" Suction Liner (MI285-0008), 1000mL "Bag" Suction Liner with solidifier (MI285-0015), 1000mL Suction Canister (MI129-0013), 1000mL Suction Lid Liner (MI217), 1200mL Rigid Suction Canister (MI056-0012), 1300mL Suction Canister (MI129), 1300mL Suction Liner (MI157), 1500mL "Bag" Suction Liner (MI286-0008) and more

Devices it lists

Device	Product code	Class	Role	Source
Bottle, Collection, Vacuum	KDQ	2	Complaint file establishment	accessdata.fda.gov
Brush, Dermabrasion, Powered	GFE	1	Manufacturer	accessdata.fda.gov
Catheter And Tip, Suction	JOL	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Catheter, Cholangiography	GBZ	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Catheter, Ventricular, General & Plastic Surgery	GBS	1	Complaint file establishment	accessdata.fda.gov
Negative Pressure Wound Therapy Powered Suction Pump	OMP	2	Complaint file establishment, Repackager or relabeler, Specification developer	accessdata.fda.gov
Sleeve, Limb, Compressible	JOW	2	Contract 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
March 8, 2023	K213906	extriCARE 1000 Negative Pressure Wound Therapy System	OMP	Substantially Equivalent	Alleva Medical, Ltd.	accessdata.fda.gov
February 9, 2023	K221223	extriCARE® 3000 Negative Wound Pressure Therapy System	OMP	Substantially Equivalent	Alleva Medical Devices	accessdata.fda.gov
February 3, 2015	K143362	extriCARE 3600 Negative Pressure Wound Therapy System 1000cc canister	OMP	Substantially Equivalent	Devon Medical Products	accessdata.fda.gov
September 19, 2014	K140634	extriCARE 2400 NPWT System with extriCARE 2400 NPWT Pump and extriCARE NPWT Foam Dressing Kit	OMP	Substantially Equivalent	Devon Medical, Inc.	accessdata.fda.gov
September 27, 2013	K132252	EXTRICARE 100CC/ 250CC/ 400CC CANISTERS	OMP	Substantially Equivalent	Devon Medical	accessdata.fda.gov
February 10, 2012	K110078	EXTRICARE	OMP	Substantially Equivalent	Devon Medical Products, Inc.	accessdata.fda.gov

Compare with other makers

Updated March 8, 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.