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 1889 of 3531

510(k) clearances, page 1889 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K970327	Scleral Shell	Southwest Artificial Eyes, Inc.	HQT	Class II	1997-07-07
K970320	Scleral Shell	Xavier A. Guerra, Ocularist, Inc.	HQT	Class II	1997-07-07
K970319	Ocular Conformer	Xavier A. Guerra, Ocularist, Inc.	HQN	Class II	1997-07-07
K970318	Ocular Conformer	Southwest Artificial Eyes, Inc.	HQN	Class II	1997-07-07
K963848	Manual Resuscitator	Owens-Brigam Medical Co.	BTM	Class II	1997-07-07
K963249	Epilight Hair Removal System	Esc Medical Systems, Ltd.	GEX	Class II	1997-07-07
K961734	Capiox 308 Hollow Fiber Oxygenator W/integrated Heat Exchange	Terumo Medical Corp.	DTZ	Class II	1997-07-07
K972089	Alexander Manufacturing Co. Rechargeable Battery Part Number Ms06224	Alexander Mfg. Co.	MRZ	Class II	1997-07-03
K972084	Alexander Manufacturing Co. Rechargeable Battery Part Number M212	Alexander Mfg. Co.	FLN	Class II	1997-07-03
K972082	Custom Nasal Splint	Boston Medical Products, Inc.	LYA	Class I	1997-07-03
K972068	Unicap Specific Ige Feia Assay, Latex Allergen Immunocap K82	Pharmacia, Inc.	DHB	Class II	1997-07-03
K972060	Nasal Septal Button	Boston Medical Products, Inc.	LFB	Unclassified	1997-07-03
K972038	Intruder	The Buzzz Corp.	INI	Class II	1997-07-03
K972037	Prowler	The Buzzz Corp.	INI	Class II	1997-07-03
K972036	Stealth	The Buzzz Corp.	INI	Class II	1997-07-03
K972019	Pefect Shot	International Imaging Electronics	EIA	Class I	1997-07-03
K971873	Levo Active-Easy Lae	Levo USA	IPL	Class II	1997-07-03
K971866	Alexander Manufacturing Co. Rechargeable Battery Part Number Ms61010	Alexander Mfg. Co.	FLL	Class II	1997-07-03
K971865	Alexander Manufacturing Co. Rechargeable Battery Part Number M12/500-3P	Alexander Mfg. Co.	LDR	Class II	1997-07-03
K971835	Anti-Thyroglobulin (Tg) Microplate Elisa	Monobind, Inc.	DDC	Class II	1997-07-03
K971834	Anti-Thyroid Peroxidase (Tpo) Microplate Elisa	Monobind, Inc.	JNL	Class II	1997-07-03
K971826	Alexander Manufacturing Co. Rechargeable Battery Part Number M12/500	Alexander Mfg. Co.	LDR	Class II	1997-07-03
K971809	Isolate	FUJIFILM Biosciences Inc.	MQL	Class II	1997-07-03
K971699	Argosy Dynameq	Argosy Electronics	ESD	Class I	1997-07-03
K971666	Smart - Fit, Prepowdered Nitrile Examination Gloves	Sj Medical Products (M) Sdn Bhd	LZA	Class I	1997-07-03
K971635	Azithromycin Antimicrobial Susceptibility Test Disc	Oxoid, Ltd.	JTN	Class II	1997-07-03
K971633	Piperacillin/tazobactam Antimicrobial Susceptibility Test Disc	Oxoid, Ltd.	JTN	Class II	1997-07-03
K971631	Cefotetan Antimicrobial Susceptibility Test Disc	Oxoid, Ltd.	JTN	Class II	1997-07-03
K971605	Resound Ed4 Personal Hearing System W/remote Control Option	Resound Corp.	ESD	Class I	1997-07-03
K971489	Ratational Angiography Option for Philips Multidiagnost 4	Philips North America LLC	IZI	Class II	1997-07-03
K971448	Cordis Opta Lp Pta Balloon Catheter	Cordis US Corp.	LIT	Class II	1997-07-03
K971380	Medrad Flex Interface Device	Medrad, Inc.	LNH	Class II	1997-07-03
K971347	Medisurf	International Regulatory Consultants	LMD	Class I	1997-07-03
K971279	Version 4 Operating System Software	FUJIFILM Healthcare Americas Corporation	LNH	Class II	1997-07-03
K971278	Pure Company Fluid Delivery System	Pure Co.	EIA	Class I	1997-07-03
K971268	Bone & Marrow Cllection System	Biomedical International Corp.	GEY	Class I	1997-07-03
K970579	One Step Morphine Card Test	Teco Diagnostics	DNK	Class II	1997-07-03
K970548	One Step Marijuana Card Test	Teco Diagnostics	LDJ	Class II	1997-07-03
K970398	Sharps Container	Custom Medical Plastics, Inc.	FMI	Class II	1997-07-03
K970383	Sharps Container	Custom Medical Plastics, Inc.	FMI	Class II	1997-07-03
K970300	Natural-Hip System Porous Stem with Ha/csti	Intermedics Orthopedics	LPH	Class II	1997-07-03
K970191	Uniject Examination Gloves	Uniject Gloves, Ltd.	LYY	Class I	1997-07-03
K970073	Bio-Esthetic Indirect Abutment	Steri-Oss, Inc.	NHA	Class II	1997-07-03
K965245	Tbd	Utah Medical Products, Inc	HGI	Class II	1997-07-03
K965230	Abbott Lifecare Standard Tubing Infusion Pump	Abbott Mfg., Inc.	FRN	Class II	1997-07-03
K965179	Insight Diagnostic Imaging Workstation Nit-Du0-Zoo	Neo Imagery Technologies, Inc.	LLZ	Class II	1997-07-03
K965110	N-Assay Tia Multi Crp Calibrator Set	Crestat Diagnostics, Inc.	DCK	Class II	1997-07-03
K964873	Silkair Low Airloss Therapy	Hill-Rom Inc.	IOQ	Class II	1997-07-03
K964172	Medtronic Model 3991A, 3992A, 3993A, 3994A Leads or Transverse Tripolar Leads or Ttl	Medtronic, Inc.	GZB	Class II	1997-07-03
K962767	Ms401097-17,Ms722-K,ms720,ms721,ms722	Alexander Mfg. Co.	HLJ	Class II	1997-07-03