Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1722458

FEI Number

1000138447

Entity Name

ALLISON MEDICAL, INC.

City/State/Country

Littleton, CO, US

Establishment Address

8091 Shaffer Pkwy, Littleton, CO 80127, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

ALLISON MEDICAL, INC. (Owner Number: 9009434)

Owner / Operator Contact Address

8091 Shaffer Parkway, --, Littleton, CO 80127, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K124037

PMA Number

N/A

All Registered Proprietary Names

SureComfort EaseInject CAREPOINT Sure Comfort Pen Needle Sure Comfort Pen Needle SureComfort Freedom SureComfort SureComfort SureComfort SureComfort Healthwise Lancets Up&Up Lancets Up&Up Lancing Pens SureComfort Lancing Pens SureComfort Lancets CarePoint

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2013-05-02
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2014-11-04
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2013-08-21
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2013-08-21
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2017-08-16
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2016-11-02
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2025-02-10
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2025-05-20
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2025-02-07
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2016-09-12
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2012-04-02
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2022-02-11
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2022-02-11

Official Correspondent

Isaiah Ray

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ALLISON MEDICAL, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K812404	Nu Tech Medical Systems	BUTTERFLY NEEDLE ASSEMBLY	1981-09-09
K880350	Honway International Co.	YUE/FA DISPOSABLE SYRINGE	1988-02-16
K003571	Terumo Medical Corp.	SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE	2001-02-12
K130132	Medipurpose Pte. , Ltd.	BABYLANCE HEEL INCISION DEVICE	2013-02-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2022	Bard Peripheral Vascular Inc	2	REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796
Z-0003-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
Z-0004-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes
Z-0005-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes
Z-0005-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1722458. Last updated year: 2026. Please use registration number 1722458 when referencing this establishment in official correspondence.