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 2026-11-05, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,132 of the 176,529 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	2,732

176,529 records, page 1252 of 3531

510(k) clearances, page 1252 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K061893	Integra Radionics Xknife Rt 4	Integra Radionics, Inc.	MUJ	Class II	2006-07-25
K061724	Powder Free Nitrile Examination Glove, Grape Scented (Blue and White)	Smart Glove Corp. Sdn Bhd	LZA	Class I	2006-07-25
K061665	Arthrex 4.5 Mm, 5.5 Mm and 6.5 Mm Corkscrew Ft	Arthrex GmbH	HWC	Class II	2006-07-25
K061657	Hitch Lactosorb Suture Anchor	Arthrotek, Inc.	JDR	Class II	2006-07-25
K061637	Echoview/ Shimasonic Diagnostic Ultrasound System, Model Sdu-2200Pro	Shimadzu Medical Systems	IYN	Class II	2006-07-25
K061582	Varisource 200 Hdr Afterloader	Varian Medical Systems, Inc.	JAQ	Class II	2006-07-25
K061449	Syngo Expert-1	Siemens Medical Solution	JAK	Class II	2006-07-25
K061441	Ebi 5.5 Helical Flange Spinal System	Ebi, LLC	MNH	Class II	2006-07-25
K061429	Dynamic MRI Software Option for C-Scan, E-Scan Xq and E-Scan Opera	Esaote S.p.A.	LNH	Class II	2006-07-25
K061421	Erad Pacs	Erad, Inc.	LLZ	Class II	2006-07-25
K061405	Apnealink, Model 22302	Resmed Germany, Inc.	MNR	Class II	2006-07-25
K061331	Oral Balance Liquid/ Gel	Laclede, Inc.	LFD	Unclassified	2006-07-25
K060898	Pulsion Picco Plus, Model 8100	Pulsion Medical Systems AG	DXG	Class II	2006-07-25
K060808	Brainpro, Brainpro Access	Pajunk GmbH Medizintechnologie	HAW	Class II	2006-07-25
K060793	Element Blood Glucose Test System	Home Diagnostics, Inc.	NBW	Class II	2006-07-25
K060769	Hydromark Biopsy Site Marker	Biopsy Sciences, LLC	NEU	Class II	2006-07-25
K060540	Xpert, Genexpert Dx System	Cepheid	NJR	Class I	2006-07-25
K060527	Instant-View Bup/nbup Urine Test. Instant-Verdict Bup/nbup Urine Test; Instant-Confirmatory Bup/nbup Urine Test	Alfa Scientific Designs, Inc.	DJG	Class II	2006-07-25
K060037	Fitpack	ASP Plastics Pty Ltd.	MMK	Class II	2006-07-25
K053446	Gen-Probe Aptima Assay for Chlamydia Trachomatis, Model 1088	Hologic, Inc.	MKZ	Class I	2006-07-25
K061786	Versys Fiber Metal Midcoat Low Head Center Hip Prosthesis	Zimmer GmbH	LPH	Class II	2006-07-24
K061229	Unity Lx Anterolateral Lumbar Plate Fixation System	Blackstone Medical, Inc.	KWQ	Class II	2006-07-24
K061151	Pioneer Vertebral Spacer (Vertebral Spacer)	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)	MQP	Class II	2006-07-24
K053490	Merits Health Products Portable Nebulizer	Merits Health Products, Inc.	CAF	Class II	2006-07-24
K052668	Or Specific Big Case Back Table Cover	Or Specific, Inc.	KKX	Class II	2006-07-24
K061977	Pelex-04 Wireless Electrocardiograph with Software Accessories	Pinmed, Inc.	DXH	Class II	2006-07-21
K061969	Preformance Posts and Temporary Cylinders	ZimVie US Corp LLC	NHA	Class II	2006-07-21
K061946	Acuson X300 Diagnostic Ultrasound System	Siemens Medical Solutions USA, Inc.	IYN	Class II	2006-07-21
K061823	Admira Protect/admira Protect Single Dose	Voco GmbH	EBC	Class II	2006-07-21
K061743	Venous Hardshell Cardiotomy Reservoir W/safeline Coating, Model Bsq-Vhk 2000;Vacuum Tight, Model Bsq-Vhk 2001	MAQUET CARDIOPULMONARY GmbH	DTN	Class II	2006-07-21
K061713	Magis1;magis2	Direx Systems Corp.	IYE	Class II	2006-07-21
K061687	Microscan Dried Gram Negative Mic/combo Panels	Siemens Healthcare Diagnostics Inc.	JWY	Class II	2006-07-21
K061683	Tina-Quant Myoglobin Gen.2 Test System	Roche Diagnostics GmbH	DDR	Class II	2006-07-21
K061588	Vitros Chemistry Products Hcy Reagent, Vitros Chemistry Products Calibrator Kit 27, Hcy Performance Verifiers	Ortho-Clinical Diagnostics, Inc.	LPS	Class II	2006-07-21
K061574	Coulter Lh 750 Hematology Analyzer, Model 6605632	Siemens Healthcare Diagnostics Inc.	GKZ	Class II	2006-07-21
K061556	Amedica Drug Screen Thc, Coc,opi,amp,met,pcp,mdma,bar,bzo,; Model C1010,c1015,c1020	Amedica Biotech, Inc.	LDJ	Class II	2006-07-21
K061530	Md-Temp	Meta Biomed Co., Ltd.	EBG	Class II	2006-07-21
K061447	5M Monochrome Digital Mammography Lcd Monitor Mdl2116a (Me551i2)	Totoku Electric Co., Ltd.	LLZ	Class II	2006-07-21
K061418	Quantiva	Tomographix IP, Ltd.	LLZ	Class II	2006-07-21
K061387	Veresure Bell	Veresure, Inc.	HIF	Class II	2006-07-21
K060998	Qms Tobramycin	Seradyn, Inc.	LCR	Class II	2006-07-21
K060895	Nomosstat, Version 1.0	Nomos Corp.	IYE	Class II	2006-07-21
K060739	Monoplace Hyperbaric Oxygen Treatment System, Model Blks-307	Khrunichev State Research & Production Space Centr	CBF	Class II	2006-07-21
K060619	Diazyme Carbon Dioxide Enzymatic Assay Kit, Model Kz122a	Diazyme Laboratories, Inc.	KHS	Class II	2006-07-21
K060489	Dade Pfa-100 Platelet Function Analyzer and Reagents	Siemens Healthcare Diagnostics Inc.	JOZ	Class II	2006-07-21
K060205	General Chemistries on Abx Pentra 400 Clinical Chemistry Analyzer	Horiba Abx	CJE	Class II	2006-07-21
K053597	I-Stat B-Type Natriuretic Peptide (Bnp)	I-Stat Corp.	NBC	Class II	2006-07-21
K051958	Mp Rapidoxy Test Strip, Model 07Rd-7073	Mp Biomedicals, LLC	DJG	Class II	2006-07-21
K061470	Del Sol Blue Light Therapy System	Edge Systems Corp.	GEX	Class II	2006-07-20
K061439	Aequalis Reversed Prosthesis	TORNIER Inc.	PHX	Class II	2006-07-20