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

Allison Medical, Inc.: FDA-registered device maker in Littleton, CO, United States, 9 510(k) clearances

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

Allison Medical, Inc. is registered with the FDA (registration 1722458) in Littleton, CO, United States. It lists 4 device types. The FDA files 9 510(k) clearances under its listings, the newest dated April 3, 2025. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 1722458
FEI number: 1000138447
Address: 8091 Shaffer Pkwy, Littleton, CO, United States, 80127
Owner or operator: ALLISON MEDICAL, INC. (9009434)
Roles: Complaint file establishment
First device listed: April 2, 2012
Registered through: 2026
Brand names listed: CarePoint, EaseInject, FreeStyle Precision, Healthwise Alcohol Prep Pads, Healthwise Lancets, InControl, Premier Value, Select Brand and more

Devices it lists

Device	Product code	Class	Role	Source
Bandage, Liquid, Skin Protectant	NEC	1	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

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 3, 2025	K250658	SureFine Pen Needle	FMI	Substantially Equivalent	Shina Med Corporation	accessdata.fda.gov
March 1, 2022	K210848	Sure-Fine Insulin Syringes	FMF	Substantially Equivalent	Shina Med Corporation	accessdata.fda.gov
September 9, 2016	K152879	Sure-Fine Insulin Syringes	FMF	Substantially Equivalent	Shina Med Corporation	accessdata.fda.gov
June 7, 2016	K152877	SureFine Pen Needle	FMI	Substantially Equivalent	Shina Med Corporation	accessdata.fda.gov
February 2, 2016	K152410	Top Fine Pen Needle	FMI	Substantially Equivalent	Medexel Co.,Ltd	accessdata.fda.gov
September 12, 2013	K124037	JUNG RIM SINGLE USE HYPODERMIC SYRINGE WITH NEEDLE	FMF	Substantially Equivalent	Jung Rim Medical Industrial Co., Ltd.	accessdata.fda.gov
April 12, 2012	K113186	STERILE INSULIN PEN NEEDLE	FMI	Substantially Equivalent	Shina Corp.	accessdata.fda.gov
August 6, 2009	K091167	SHINA INSULIN SYRINGE-INCLUDING ACCU-SURE INSULIN SYRINGES	FMF	Substantially Equivalent	Shina Corp.	accessdata.fda.gov
March 1, 2007	K063348	TOP FINE INSULIN SYRINGE	FMF	Substantially Equivalent	Daejin Tech Medical Manufacturing Co., Ltd.	accessdata.fda.gov

Recalls

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

Initiated	Event	Class	Status	Product	Reason	Source
September 3, 2020	91092	Class II	Completed	CarePoint 60 mL Syringe Without Needle, REF: 04-7560	Syringe without needle may have a green substance on the plunger. Substance found to be nontoxic but its effect on drug potency or interaction is unknown.	accessdata.fda.gov
January 19, 2018	91083	Class II	Completed	InControl Insulin Syringes, Short Needle, 29 Gauge, 1CC	Insulin syringe retail packages incorrectly labeled as "Short Needle".	accessdata.fda.gov

Compare with other makers

Updated April 3, 2025. 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.