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 2946 of 3529

510(k) clearances, page 2946 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K852909	Mvp - 6000	Waters Instruments, Inc.	BZC	Class II	1985-11-14
K852887	Cr5 Cardiac Monitor	Cardiac Recorders, Ltd.	DRT	Class II	1985-11-14
K852761	Cilas Model Ym101	Inframed, Inc.	LLO	Class II	1985-11-14
K852460	Gentle Expressions Automatic Breast Pump & Feed Sy	Healthteam	HGX	Class II	1985-11-14
K852326	Unistim Unt-1	Neuromed, Inc.	GZB	Class II	1985-11-14
K852284	Digirad System 1 and the Reusuable Image Media	Digirad Corp.	LLZ	Class II	1985-11-14
K851662	Logos8821 1-Channel Direct-Writing Electrocardiogr	Logos Medical Co., Ltd.	DPS	Class II	1985-11-14
K840574	Ebm-500	Bosch Hearing Instruments, Inc.	DXN	Class II	1985-11-14
K854344	Aquacel Surgical Prep Pads	Advanced Ortho-Technology, Inc.	FRO	Unclassified	1985-11-13
K854327	Subcutaneous Tunneling Needles & Handles	Concord Laboratories, Inc.	GCB	Class I	1985-11-13
K854283	Cambridge Model Xt1000	Cambridge Medical Instruments, Inc.	IOL	Class I	1985-11-13
K854263	Setma Fht, Model St 8130	Setma, Inc.	ILJ	Class II	1985-11-13
K854238	Needle W/stylet for Implantation	Microvasive	GAA	Class I	1985-11-13
K854192	Anadias Nasal Saw Blades	Anadias, Inc.	GFA	Class I	1985-11-13
K854191	Mecron Uncemented Structured Stem Hip	Mecron Medical Products, Inc.			1985-11-13
K854146	Surgical & Dental Instrument	Baort, Inc.	GEN	Class I	1985-11-13
K854123	Midas Rex Operating Room Vise	Midas Rex Pneumatic Tools, Inc.			1985-11-13
K854008	Statlock	Healthtek, Inc.	LHI	Class II	1985-11-13
K853778	The Dextra Precision Power Unit	Storz Instrument Co.	GEY	Class I	1985-11-13
K853653	Sana-Lube	Huntington Laboratories, Inc.	KMJ	Class I	1985-11-13
K853376	Morgan Suture-Drill	Bowen & Company, Inc.	HWE	Class I	1985-11-13
K853311	Linear Array Probe Plb-310M for Sal-32B	Toshiba Medical Systems	IYO	Class II	1985-11-13
K853270	Centercom Control	Carrom Healthcare, Inc.	FNL	Class II	1985-11-13
K852503	R.r. Pronto Siringa	Medical Hospital Equipment	FMF	Class II	1985-11-13
K852470	Surgilase 40S	Surgilase, Inc.	GEX	Class II	1985-11-13
K850792	Odac-on Demand Aralgesia by Computer-Infusion Pump	Janssen Pharmaceutica NV	FRN	Class II	1985-11-13
K854383	Keratolux	Carl Zeiss, Inc.	HPL	Class I	1985-11-12
K854343	Siom	South West Intl., Inc.	HQZ	Class I	1985-11-12
K854305	Dart Iron & Iron Binding Capacity Reagent	Coulter Electronics, Inc.	CFM	Class I	1985-11-12
K854304	Keymed Office Couch	Keymed, Inc.	FPO	Class II	1985-11-12
K854298	Iron	Boehringer Mannheim Corp.	CEM	Class II	1985-11-12
K854288	Ophalmic Laser Photocoagulator	Mira, Inc.	HQF	Class II	1985-11-12
K854275	Thayer-Martin Medium (Mod)	R. Kent Richards, Inc.	JTY	Class II	1985-11-12
K854264	Sunglasses/optical Frames	Wha Chun Industries, Co., Ltd.	HQY	Class I	1985-11-12
K854255	Span / Aid Syringe	Span-America Medical Systems, Inc.	FMF	Class II	1985-11-12
K854244	The Keeler All Pupil Indirect Ophthalmoscope	Keeler Instruments, Inc.	HLI	Class II	1985-11-12
K854230	Mebiasis Agar Gel Diffusion Kit	Lmd Laboratories	KHW	Class II	1985-11-12
K854218	The Ultra-Mate Lens	Optical Systems Intl., Inc.	HQG	Class I	1985-11-12
K854138	Kodakektachem Dtr Module	Eastman Kodak Company	JJE	Class I	1985-11-12
K854108	Polyvalent Fluorescent Antibody Reagents for Legio	Medical Diagnostic Technologies, Inc.	LHL	Class II	1985-11-12
K854093	Leuco Prep	BD Becton Dickinson Vacutainer Systems Preanalytic	JCF	Class I	1985-11-12
K854066	Double Antibody C-Peptide Ria Kit	Siemens Healthcare Diagnostics Inc.	JKD	Class I	1985-11-12
K854035	Micro Therm Mt-500 & Mt-600	Medequi, Division of King Yip Co., Inc.	FLL	Class II	1985-11-12
K853986	Thromboplastin-R Reagent	American Dade	JPA	Class II	1985-11-12
K853890	Ophthalmic Laser Photocoagulator	Mira, Inc.	HQF	Class II	1985-11-12
K853851	Fresenius Disposable Blood Lines	Seratronics, Inc.	FJK	Class II	1985-11-12
K853604	Ace-Kyle Dye Injection Needle P/n 14082	Today'S Machining & Design, Inc.	FMI	Class II	1985-11-12
K853584	Cadd-1, Model 5100 HF, Ambulatory Infusion Pump	Deltec Systems, Inc.	FRN	Class II	1985-11-12
K853549	Mcgaw/drop Watch Flow Monitor	American Mcgaw	FLN	Class II	1985-11-12
K853399	Virogen Rotatest Slide Test	Armkel, LLC	LIQ	Class I	1985-11-12