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 2026-10-22, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 2833 of 3529

510(k) clearances, page 2833 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K870847	Schultz Phalangeal Component Driver	Warsaw Orthopedic, Inc.	HWR	Class I	1987-03-13
K870846	Schultz Mp Component Punch	Warsaw Orthopedic, Inc.	HWP	Class I	1987-03-13
K870844	Schultz Prosthesis Component Inserter Extractor	Warsaw Orthopedic, Inc.	HWB	Class I	1987-03-13
K870828	Intersect Systems Enzymatic Cholesterol Reagent	Intersect Systems, Inc.	CHH	Class I	1987-03-13
K870827	Intersect Systems Triglyceride-Gpo Reagent	Intersect Systems, Inc.	CDT	Class I	1987-03-13
K870795	EMG Electrodes and Extension Cords	Nihon Kohden America Inc	IKT	Class II	1987-03-13
K870777	Progress Plus Selective Chemistry Analyzer	Kone Instruments, Inc.	JJF	Class I	1987-03-13
K870776	Raichem(tm) Phosphorus Reagent, Rapid Endpoint	Reagents Applications, Inc.	CEO	Class I	1987-03-13
K870768	Ac Adapter Accessory, Product Code 600123A	Deltec Systems, Inc.	FRN	Class II	1987-03-13
K870691	Dahlberg Model UV Trimline in-the-Ear Hearing Aid	Dahlberg Electronics, Inc.	ESD	Class I	1987-03-13
K870632	Fast Uric Acid	Sclavo, Inc.	KNK	Class I	1987-03-13
K870631	Fast Glucose	Sclavo, Inc.	CGA	Class II	1987-03-13
K870522	Depend Underpad	Kimberly-Clark Corporation	KME	Class I	1987-03-13
K870474	Instaject	Pavel Jordan & Associates, Inc.	KZH	Class II	1987-03-13
K870351	Ez Complement Reagents, 78N2212	Diamedix Corp.	DHL	Class I	1987-03-13
K870324	#014460-120 3-Way & #014461-120 4-Way Stopcock	Clinical Connections, Inc.	FMG	Class II	1987-03-13
K870242	Intermate(tm)	Infusion Systems Corp.	FRN	Class II	1987-03-13
K870229	Hearing Aid Test System Model Hat 1000	Madsen Electronics (Canada), Ltd.	ETW	Class II	1987-03-13
K870166	Platform Mattress W/disposable Bedpan Bag	George C. Kuhn	FNJ	Class I	1987-03-13
K870106	Coat-a-Count Irma Hcg Kit and Its Components	Siemens Healthcare Diagnostics Inc.	JHI	Class II	1987-03-13
K870030	The Screener Gsi 55 Abr Screener	Grason-Stadler, Inc.	GWJ	Class II	1987-03-13
K870025	Amresco Flow Pac Carbon Dioxide (CO2) Reagents	American Research Products Co.	KMS	Class II	1987-03-13
K865071	Thyroid Stimulating Hormone (Tsh Irma) Ria Kit	Immuchem Corp.	JLW	Class II	1987-03-13
K865011	Pregelled Disposable Electrode, Silver-Silver	Labeltape Meditect, Inc.	DRX	Class II	1987-03-13
K864968	Bacpac (Tm), Model 6500	Medical Devices Inc.	GZJ	Class II	1987-03-13
K864872	Medica Easylyte Sodium/potassium Analyzer	Medica Corp.	JGS	Class II	1987-03-13
K864751	Tdxr Cannabinoids	Abbott Medical	LDJ	Class II	1987-03-13
K864586	S&w Electrode Types 888, 844, 988 and 944	S & W Medico Teknik	DRX	Class II	1987-03-13
K864543	Sunglasses	Image of Hawaii	HQY	Class I	1987-03-13
K864515	Ring Upm Total Hip Replacement	Downs Surgical, Ltd.	KWA	Class III	1987-03-13
K864313	CO2 Reagent Set	Hf Scientific, Inc.	CIE	Class II	1987-03-13
K864174	Ubimagiwel(tm)hcg Quantitative and Qualitative	United Biotech	JHI	Class II	1987-03-13
K863245	Syva Ets System	Syva Co.	JJF	Class I	1987-03-13
K862766	Epison, Alerting System for Epileptics	Zygo Industries, Inc.	LEL	Class II	1987-03-13
K861679	Shbg Irma Kit	Farmos Group, Ltd.	CDZ	Class I	1987-03-13
K870832	Oxy-Therm	M.D. Intl., Inc.	IMD	Class I	1987-03-12
K870570	Ferritin Mab Solid Phase Component System	BD Becton Dickinson Vacutainer Systems Preanalytic	DBF	Class II	1987-03-12
K870151	Total/ige Theophylline Control Sera	3M Company	JJX	Class I	1987-03-12
K865105	Affinity(tm) System	BD Becton Dickinson Vacutainer Systems Preanalytic	JJE	Class I	1987-03-12
K865081	Affinity(tm) Htsh Immunit(tm)	BD Becton Dickinson Vacutainer Systems Preanalytic	JLW	Class II	1987-03-12
K864766	Soundtek Model Ut-4700	Soundtek, Inc.	IMJ	Class II	1987-03-12
K864737	Nibp Non-Invas. Blood Press. Cart. Model 88 35 340	Siemens Medical Solutions USA, Inc.	DXN	Class II	1987-03-12
K864714	Infralux Heat Lamp	Infralux International, Inc.	ILY	Class II	1987-03-12
K864668	Ana Test Kit	Val Tech Diagnostics, Inc.	LKJ	Class II	1987-03-12
K864658	Iq Free T4 Immunoassay	BD Becton Dickinson Vacutainer Systems Preanalytic	CEC	Class II	1987-03-12
K864539	Modified Imagen(tm) Chlamydia Test	Boots-Celltech Diagnostics, Inc.	LJP	Class I	1987-03-12
K864438	Beckman Epsilon(tm) Lipase Test Kit	Beckman Instruments, Inc.	CET	Class I	1987-03-12
K864228	Apo B., Immunoturbidimetric Assay	Intl. Diagnostic Laboratories, Ltd.	MSJ	Class I	1987-03-12
K864110	Rickettsial Igg and Igm Ifa Kit	Hillcrest Biologicals	GPN	Class I	1987-03-12
K863877	Benzodiazepine Enzyme Immunoassay Kit	General Diagnostics	JXM	Class II	1987-03-12