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 2026-10-12, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,969 of the 176,366 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	2,569

176,366 records, page 3309 of 3528

510(k) clearances, page 3309 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K810260	Omed Silicone Loops	Omega-Med Intl., Inc.	KDC	Class I	1981-02-26
K810244	Porta-Puls Muscle Stimulator	General Physiotherapy, Inc.	IRO	Class I	1981-02-26
K810191	Sircam 103	Siemens Corp.	IZJ	Class II	1981-02-26
K810134	Keep-Account Sharps Disposal System	Info-Chem	MMK	Class II	1981-02-26
K810131	Administration Set	G.D. Searle and Co.	FPD	Class II	1981-02-26
K810123	The Luomanen Oral Airway	Luomanen Medical Products	CAE	Class I	1981-02-26
K810087	Urea Nitrogen, Kinetic	Bio-Analytics Laboratories, Inc.	JGZ	Class II	1981-02-26
K810059	Endo-Med Tube for Endotracheal Med	Ackrad Laboratories	CCT	Class II	1981-02-26
K810058	Ortho Quantitative Fibrinogen Assay	Ortho Diagnostic Systems, Inc.	KQJ	Class II	1981-02-26
K810044	Muscle Stimulator	Micron Instruments, Inc.	IPF	Class II	1981-02-26
K803234	Eskachem Pap Reagent	Smithkline Diagnostics, Inc.	JFH	Class II	1981-02-26
K803067	Surg-Flex 10 Light	Medical Products Development, Inc.	FSQ	Class II	1981-02-26
K802852	Humidifier	Airlife, Inc.	BTT	Class II	1981-02-26
K810345	Liquid Scintillation Spectrophotometer	Beckman Instruments, Inc.	JJJ	Class I	1981-02-25
K810304	Model Lc-85 UV Detector	Revvity Health Sciences, Inc.	LDM	Class I	1981-02-25
K810302	Quantimune Hlh Ria Human Lutenizing Horm	Bio-Rad	CEP	Class I	1981-02-25
K810301	Crithidia Luciliae Native DNA-Ifa Test	IMMUNO CONCEPTS, NA, Ltd.	DHN	Class II	1981-02-25
K810281	Urological Catheters	Latex Ind., Inc.	KOD	Class II	1981-02-25
K810272	Bio Care Oxygen Concentrator	The Biomed Group	CAW	Class II	1981-02-25
K810194	Wall Cassette Holder - Trac44	Philips North America LLC	IXY	Class I	1981-02-25
K810183	Pro-Top-Angio Shift Table Top Extension	Philips North America LLC	IZI	Class II	1981-02-25
K810179	Dual Trace Patient Monitor 116,118,120	Honeywell, Inc.	DSK	Class II	1981-02-25
K810178	Patient Monitor Cm111, 112	Honeywell, Inc.	DSK	Class II	1981-02-25
K810177	Patient Monitor Model Cm130, 140	Honeywell, Inc.	DXG	Class II	1981-02-25
K810176	ECG Function Block	Honeywell, Inc.	DPS	Class II	1981-02-25
K810172	Pressure Function Blocks	Honeywell, Inc.	DSK	Class II	1981-02-25
K810171	Peripheral Pulse Function Blocks	Honeywell, Inc.	DSK	Class II	1981-02-25
K810170	Trend Graph Function Block	Honeywell, Inc.	DXG	Class II	1981-02-25
K810169	Central Station Controller Ac100/ce100	Honeywell, Inc.	DSF	Class I	1981-02-25
K810168	Slave Monitors Dc109 & Vs109	Honeywell, Inc.	DXJ	Class II	1981-02-25
K810167	Single Channell Recorder Ar110	Honeywell, Inc.	DSF	Class I	1981-02-25
K810166	1,2,3 Channell Recorders (Ar150,ar250,-)	Honeywell, Inc.	DSF	Class I	1981-02-25
K810165	Dual Trace Video Monitor Vm 410	Honeywell, Inc.	DXJ	Class II	1981-02-25
K810164	Vc 430 Video Converter	Honeywell, Inc.	DXJ	Class II	1981-02-25
K810127	Gambro Bicarbonate Module, Bcm-10	Gambro, Inc.	FKR	Class II	1981-02-25
K810046	Cordia a	Cordis US Corp.	KHW	Class II	1981-02-25
K803109	Uristop	The Sora Co.			1981-02-25
K810390	Ast (UV) Test	Boehringer Mannheim Corp.	CIT	Class II	1981-02-23
K810356	Bicarbonate Test	Boehringer Mannheim Corp.	KHS	Class II	1981-02-23
K810355	Alt (UV) Test	Boehringer Mannheim Corp.	CKA	Class I	1981-02-23
K810354	Percuss-O-Flex Foot & Hand Massager	Modern Reflexology, Inc.	ISA	Class I	1981-02-23
K810353	Harris Cement Restrictor	Cintor Orthopaedic Div.	LZN	Class II	1981-02-23
K810351	Radioimmunoassay, Total Triiodothronie	Endocrine-Metabolic Center	CDP	Class II	1981-02-23
K810348	Cm 3	Instrumentation Industries, Incorporated	CBP	Class II	1981-02-23
K810316	Surgikos Face Mask	Surgikos, Inc.	FXX	Class II	1981-02-23
K810279	Denture Cleaner	Mcdennan Oral Products, Inc.	EFT	Class I	1981-02-23
K810266	Etching Gel	Espe-Premier Sales Co.	EJK	Class II	1981-02-23
K810265	Visio-Band	Espe-Premier Sales Co.	KLE	Class II	1981-02-23
K810121	Unifocal 3	American Pacemaker Corp.	DXY	Class III	1981-02-23
K803313	Pacing System Analyzer	Medtronic, Inc.	DTE	Class II	1981-02-23