510(k) clearances

Premarket notifications cleared by FDA, newest decision first.

Every 510(k) record MDM has ingested from openFDA. Each clearance page carries the record as FDA published it, the product code it was cleared under, recalls sharing that product code, and a link to the FDA source.

Data as of 2026-10-29, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 ingested clearances have a decision year between 2012 and 2026, the 15 years shown, 2023 the highest year at 3,346.

Show the numbers

510(k) clearances by decision year, the last 15 years of ingested records
Year	Clearances
2012	3,135
2013	3,052
2014	3,202
2015	3,020
2016	2,956
2017	3,200
2018	3,062
2019	2,918
2020	2,923
2021	3,023
2022	3,209
2023	3,346
2024	3,129
2025	3,225
2026	2,669

176,466 records, page 2656 of 3530

510(k) clearances, page 2656 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K891525	M-46 Gold Base Dental Alloy	Macdonald Metals and Ceramics	EJT	Class II	1989-04-12
K891524	M-40 Gold Base Dental Alloy	Macdonald Metals and Ceramics	EJT	Class II	1989-04-12
K891523	M-20 Gold Base Dental Alloy	Macdonald Metals and Ceramics	EJT	Class II	1989-04-12
K891522	M-4 Gold Base Dental Alloy	Macdonald Metals and Ceramics	EJT	Class II	1989-04-12
K891521	M-1 Gold Base Dental Alloy	Macdonald Metals and Ceramics	EJT	Class II	1989-04-12
K891520	C-87 Gold Base Dental Alloy	Macdonald Metals and Ceramics	EJT	Class II	1989-04-12
K891519	C-86 Gold Base Dental Alloy	Macdonald Metals and Ceramics	EJT	Class II	1989-04-12
K891518	C-76 Gold Base Dental Alloy	Macdonald Metals and Ceramics	EJT	Class II	1989-04-12
K891517	C-63 Gold Bae Dental Alloy	Macdonald Metals and Ceramics	EJT	Class II	1989-04-12
K891514	C-5 Palladium Base Dental Alloy	Macdonald Metals and Ceramics	EJT	Class II	1989-04-12
K891476	C. Albicans Screen	Carr-Scarborough Microbiologicals, Inc.	JXC	Class I	1989-04-12
K891186	Repositionable Bitewing X-Ray Film Holder Kit	Benn Research, Ltd.	EHA	Class I	1989-04-12
K891058	Dental Gown	Dispomed, Inc.	FYA	Class II	1989-04-12
K891056	Surgical Cone Mask	Dispomed, Inc.	FXX	Class II	1989-04-12
K891053	Dental Bib	Dispomed, Inc.	FYB	Class II	1989-04-12
K891052	Splash Guard Goggle	Dispomed, Inc.	FXX	Class II	1989-04-12
K891051	Surgical Face Mask-Ear Loop	Dispomed, Inc.	FXX	Class II	1989-04-12
K890904	Modified Stockert-Shiley Caps Multi. Roller Pump	Shiley, Inc.	DWB	Class II	1989-04-12
K890898	Model 611101 Contrast Injection Device	Medtronic Versaflex, Inc.	DXT	Class II	1989-04-12
K890410	Revised Ohmeda Modulus II Anesthesia Gas Machine	GE Healthcare	BSZ	Class II	1989-04-12
K890319	Uric Acid Kit, Codes 4825400 and 4825050	American Research Products Co.	KNK	Class I	1989-04-12
K890287	Sharplan Model 1050 Sealed-Off CO2 Surgical Laser	Sharplan Lasers, Inc.	GEX	Class II	1989-04-12
K890133	Ocular Connection Machine(tm)	Innovision Medical, Inc.	HQE	Class II	1989-04-12
K885344	Immunocomb(tm) Toxoplasma Igg Antibody Test Kit	Orgenics, Ltd.	LGD	Class II	1989-04-12
K884829	Ebv Early Antigen (R+d)	Hillcrest Biologicals	JRY	Class I	1989-04-12
K884661	D-Scope III	Medx, Inc.	IYX	Class I	1989-04-12
K884533	Sensodyne Sealant Dentin Conditioning System	Block Drug Company, Inc.	KLE	Class II	1989-04-12
K891907	Qbc(r) Centrifugal Hematology Contr/multi Modified	R & D Systems, Inc.	JCN	Class II	1989-04-11
K891885	Patient Examination Gloves (Latex)	Alfaseal Sdn. Bhd.	LYY	Class I	1989-04-11
K891883	Patient Examination Gloves (Latex)	China National Machinery & Equipment Import & Expo	LYY	Class I	1989-04-11
K891866	Rubber Latex Patient Examination Gloves	Amsia Intl., Inc.	LYY	Class I	1989-04-11
K891860	Patient Examination Gloves (Vinyl)	Cypress Medical Products LLC	LYZ	Class I	1989-04-11
K891854	Skin Angel Brand (Patient Exam Gloves - Latex)	Unidus Corp.	LYY	Class I	1989-04-11
K891850	Ammex Latex Examination Gloves	Ammex Corp.	LYY	Class I	1989-04-11
K891568	Vinyl Exam Gloves (Mfg. Jm Gloves Co. Ltd.)	Neo-Sigma, Inc.	LYZ	Class I	1989-04-11
K891567	Vinyl Exam Gloves (Mfg. Precious Mountain ENT.)	Neo-Sigma, Inc.	LYZ	Class I	1989-04-11
K891566	Vinyl Exam Gloves (Mfg. Am Gloves Co. Ltd.)	Neo-Sigma, Inc.	LYZ	Class I	1989-04-11
K891334	Acu-Curette	Acuderm, Inc.	FZS	Class I	1989-04-11
K891128	Patient Examination Glove	Jensen Union Ent. Co., Ltd.	LYZ	Class I	1989-04-11
K891001	Microscope Knob Cover, Sterile, Disposable	Prescott's, Inc.	HRM	Class I	1989-04-11
K890925	Manan Bone Marrow Biopsy Needle	Argon Medical Devices, Inc	DWO	Class I	1989-04-11
K890920	Eagle Vision-Freeman(tm) Punctal Valve	Grace Medical, Inc.	LZU	Unclassified	1989-04-11
K890099	Modified Vas-Cath Catheter Repair Kit	Vas-Cath, Inc.	LFJ	Class II	1989-04-11
K884842	Cmv-Cube(tm)	Difco Laboratories, Inc.	LFZ	Class II	1989-04-11
K891394	Pm830 Electric Massager	Back in Action, Inc.	ISA	Class I	1989-04-10
K891286	Biotrol Chemistry Urine Control	Biotrol, USA, Inc.	JJW	Class I	1989-04-10
K891179	Edl Normal Coagulation Control	Elite Diagnostic, Ltd.	GIZ	Class II	1989-04-10
K891175	Edl Abnormal Coagulation Control	Elite Diagnostic, Ltd.	GGL	Class II	1989-04-10
K891169	Dade Thromboplastin Is	Baxter Healthcare Corporation	GJS	Class II	1989-04-10
K891117	Hdl Cholesterol Reagent	Horiba Instruments Incorporated	LBR	Class I	1989-04-10