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

Omnicell, Inc.: FDA-registered device maker in Cranberry Township, PA, United States, 1 510(k) clearance

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

Omnicell, Inc. is registered with the FDA (registration 3007880912) in Cranberry Township, PA, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated April 24, 2022. 2 recall events name it as the recalling firm (1 Class I). Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3007880912
Address: 500 Cranberry Woods Dr. Suite 400, Cranberry Township, PA, United States, 16066
Owner or operator: Omnicell, Inc. (10059398)
Roles: Complaint file establishment, Specification developer
First device listed: February 21, 2019
Registered through: 2026
Brand names listed: Anesthesia Workstation, Anesthesia-Rx, IVX Cloud, IVX Manager, IVX Station, IVX Station Reconstitution Transfer Set, IVX Station Stock Solution Transfer Set

Devices it lists

Device	Product code	Class	Role	Source
Cabinet, Table And Tray, Anesthesia	BRY	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Set, I.V. Fluid Transfer	LHI	2	Complaint file establishment, Specification developer	accessdata.fda.gov
System/Device, Pharmacy Compounding	NEP	2	Complaint file establishment, Specification developer	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
April 24, 2022	K212530	IVX Fluid Transfer Set	LHI	Substantially Equivalent	Omnicell, Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
March 25, 2026	98717	Class I	Ongoing	Rolls of label stock used with the Omnicell i.v.Station. 1. Part Number 258920028, LABEL, STERILE, IVSTATION SYRINGE (40MMX40MM). 2. Part Number 258900029, LABEL, STERILE, IVSTATION SYRINGE (20MMX40MM). Model/Catalog Num	Potential for mislabeled syringe produced by the i.v.STATION device.	accessdata.fda.gov
February 20, 2025	96422	Class II	Ongoing	IVX Station Reconstitution Transfer Set. Model Number: 298921215. Packaging: 1 set per White Tyvek Pouch, 5 Tyvek Pouches per shelf box, 10 shelf boxes per case box. IVX Station Reconstitution Transfer Set is used for th	IVX Station Reconstitution Transfer Sets were shipped in advance of the IVX Station upgrade and not intended for clinical use but are engineering devices intended for use during set up and system calibration. The items were not shipped in a validated packing configuration and sterility cannot be ensured.	accessdata.fda.gov

Compare with other makers

Updated May 13, 2026. 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.