Data / Medical devices / United States / Acme United Corp.

Acme United Corp.: FDA-registered device maker in Vancouver, WA, United States, 2 510(k) clearances

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

Acme United Corp. is registered with the FDA (registration 3023917) in Vancouver, WA, United States. It lists 29 device types. The FDA files 2 510(k) clearances under its listings, the newest dated July 20, 2017. 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: 3023917
Address: 11101 NE 37th Cir, Vancouver, WA, United States, 98682
Owner or operator: ACME UNITED CORP. (1217843)
Roles: Manufacturer, Repackager or relabeler
First device listed: July 30, 1992
Registered through: 2026
Brand names listed: Finger Cot, First Aid Only, First Aid Only Pac-Kit Physicians Care, First Aid Only Burn Gel, First Aid Only Vented Chest Seal, Pac-Kit, Physicans Care, Physicians CAre and more

Devices it lists

Device	Product code	Class	Role	Source
Accessory, Surgical Apparel	LYU	1	Repackager or relabeler	accessdata.fda.gov
Applicator, Absorbent Tipped, Non-Sterile	KXF	1	Repackager or relabeler	accessdata.fda.gov
Bandage, Elastic	FQM	1	Repackager or relabeler	accessdata.fda.gov
Bedding, Disposable, Medical	KME	1	Repackager or relabeler	accessdata.fda.gov
Depressor, Tongue, Non-Surgical	FMA	1	Repackager or relabeler	accessdata.fda.gov
Dressing, Compression	MHW	1	Repackager or relabeler	accessdata.fda.gov
Dressing, Wound, Hydrogel Without Drug And/Or Biologic	NAE	1	Repackager or relabeler	accessdata.fda.gov
Dressing, Wound, Hydrophilic	NAC	1	Repackager or relabeler	accessdata.fda.gov
Dressing, Wound, Occlusive	NAD	1	Repackager or relabeler	accessdata.fda.gov
Finger Cot	LZB	1	Repackager or relabeler	accessdata.fda.gov
First Aid Kit With Drug	LRR	N	Manufacturer, Repackager or relabeler	accessdata.fda.gov
First Aid Kit Without Drug	OHO	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Forceps	HTD	1	Repackager or relabeler	accessdata.fda.gov
Gauze / Sponge,Nonresorbable For External Use	NAB	1	Repackager or relabeler	accessdata.fda.gov
Mask, Surgical	FXX	2	Repackager or relabeler	accessdata.fda.gov
Mouthpiece, Breathing	BYP	1	Repackager or relabeler	accessdata.fda.gov
Pack, Hot Or Cold, Disposable	IMD	1	Repackager or relabeler	accessdata.fda.gov
Pack, Hot Or Cold, Reusable	IME	1	Repackager or relabeler	accessdata.fda.gov
Pad, Eye	HMP	1	Repackager or relabeler	accessdata.fda.gov
Polymer Patient Examination Glove	LZA	1	Repackager or relabeler	accessdata.fda.gov
Scissors, General, Surgical	LRW	1	Repackager or relabeler	accessdata.fda.gov
Shoe And Shoe Cover, Conductive	BWP	1	Repackager or relabeler	accessdata.fda.gov
Sling, Arm	ILI	1	Repackager or relabeler	accessdata.fda.gov
Snake Bite Suction Kit	KYP	1	Repackager or relabeler	accessdata.fda.gov
Splint, Extremity, Noninflatable, External, Sterile	FYH	1	Repackager or relabeler	accessdata.fda.gov
Stretcher, Hand-Carried	FPP	1	Repackager or relabeler	accessdata.fda.gov
Tape And Bandage, Adhesive	KGX	1	Repackager or relabeler	accessdata.fda.gov
Thermometer, Clinical Color Change	FQZ	1	Repackager or relabeler	accessdata.fda.gov
Tourniquet, Nonpneumatic	GAX	1	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
July 20, 2017	K171616	Xingyu Powder Free Nitrile Patient Examination Gloves, Blue color	LZA	Substantially Equivalent	Shandong Xingyu Gloves Co., Ltd.	accessdata.fda.gov
June 15, 2016	K153496	Disposable Surgical Face Mask	FXX	Substantially Equivalent	Xiantao Rayxin Medical Products 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
December 10, 2007	46198	Not yet classified	Terminated	First Aid Kits, soft canvas, plastic, and metal containers holding various products to include ibuprofen and other first aid supplies, in various sizes. Kits include: Labeled with First Aid Only, Inc. Vancouver, WA: Recr	Failed USP Impurity testing: the Ibuprofen supplied by its own manufacturer, used in these first aid kits, tablet refills, and cabinets, is being recalled for failing its USP limits for impurities during stability testing.	accessdata.fda.gov
August 17, 2006	36566	Not yet classified	Terminated	First Aid kits, First Aid Only brand, containing various products to include acetaminophen and other first aid supplies, various sizes, - travel size, all purpose, first aid response kit, on-the-road, recreational, outdo	Kits contain acetaminophen tablets that were recalled due to being contaminated with mold.	accessdata.fda.gov

Compare with other makers

Updated July 20, 2017. 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.