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 1768 of 3531

510(k) clearances, page 1768 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K981480	Philips Easyguide	Philips North America LLC	HAW	Class II	1999-01-28
K973227	Askina Hydrocolloid/thin	B.Braun Medical, Inc.	KMF	Class I	1999-01-28
K983988	Syntec-Taichung Non-Sterile Titanium Alloy Mini-Plate	Syntec Scientific Corp.	HRS	Class II	1999-01-27
K983100	Kavo Key Laser 1242	Kavo America	GEX	Class II	1999-01-27
K982819	Endius Spine Endoscope	Endius, Inc.	GWG	Class II	1999-01-27
K982540	Mercator Atrial High Density Array Catheter Models, 7005, 7006, 7007, Mercator Atrial High Density Array Deployment Kit,	Cardiac Pathways Corp.	MTD	Class II	1999-01-27
K982506	Verruca-Freeze Cryosurgery Delivery System	Cryosurgery, Inc.	GEH	Class II	1999-01-27
K982500	Chait Cecostomy Catheter	Cook Inc.	KNT	Class II	1999-01-27
K982384	Mercator	Harley Street Software, Ltd.	DSH	Class II	1999-01-27
K982242	Invacare CPAP	Invacare GmbH	BZD	Class II	1999-01-27
K982095	Lactosorb Meniscal Repair Device	Zimmer GmbH	MAI	Class II	1999-01-27
K981359	Gt Leggiero	Terumo Medical Corp.	DQY	Class II	1999-01-27
K972616	Oncology Plus Powder Free Latex Examination Gloves (Protein Content Labeling)	Wembley Rubber Products (M) Sdn Bhd	LYY	Class I	1999-01-27
K972065	Aurora	Neurovena Corp.	DQY	Class II	1999-01-27
K990150	Abbott Liquid Lipids Chemistry, Model #'S 3E18-01, 3E19-01	Bio-Rad	JJY	Class I	1999-01-26
K990149	Abbott Liquid Pediatric Chemistry Control, Model # 4E37-01, 4E38-01	Bio-Rad	JJY	Class I	1999-01-26
K984288	Vitros Chemistry Products Phbr Slides	Ortho-Clinical Diagnostics, Inc.	DLZ	Class II	1999-01-26
K984260	Pinnacle R/o or Redifocus Introducer R/o (Comprised of a Sheath & Dilator)	Terumo Medical Corp.	DYB	Class II	1999-01-26
K984013	Planmeca Intracam Station	Planmeca Oy	EIA	Class I	1999-01-26
K983992	Nichols Advantage Thyroglobulin Autoantibodies (Tgab) Assay	Nichols Institute Diagnostics	JZO	Class II	1999-01-26
K983912	Vistakon (Lenefilcon A)contact Lens Clear and Visibility Tint with UV Blocker	Vistakon, Johnson & Johnson Vision Products, Inc.	LPL	Class II	1999-01-26
K983809	Kls Martin Intraoral Zurich Ramus Distractor	KLS-Martin L.P.	MQN	Class II	1999-01-26
K983799	Medtronic Ps Medical Niveau Drainage System, Medtronic Ps Medical Niveau Drainage System Pole Clamp, Medtronic Ps Medicl	Medtronic PS Medical	GWM	Class II	1999-01-26
K983281	Apob	Abbott Medical	DFC	Class II	1999-01-26
K983145	Textured Powder-Free Latex Exam Gloves with Aloe Vera and Protein Content Labeling Claim (50 Micrograms or Less)	Shen Wei (USA), Inc.	LYY	Class I	1999-01-26
K982488	Bicon Bone Screw System	Bicon, LLC	DZE	Class II	1999-01-26
K982178	Vagabond Soft Restraint System	Emergent Innovations, Ltd.	FMQ	Class I	1999-01-26
K982090	Paceart Home Trak Plus Easi Event Recorder System	Paceart, Inc.	DXH	Class II	1999-01-26
K972615	Chemo Plus Powder Free Blue Latex Examination Gloves (Protein Content Labeling)	Wembley Rubber Products (M) Sdn Bhd	LYY	Class I	1999-01-26
K990061	Vitros Immunodiagnostic Products Afp Range Verifiers	Ortho-Clinical Diagnostics, Inc.	JJX	Class I	1999-01-25
K990017	Abbott Immunoassay-Mcc (Liquid) Control, Model Number 6E20-10	Bio-Rad	JJY	Class I	1999-01-25
K984605	Powder-Free Nitrile Patient Examination Glove, White (Non Colored)	Perusahaan Getah Asas Sdn. Bhd.	LZA	Class I	1999-01-25
K984274	Magnetic Resonance Diagnostic Device, Version 5.0 Operating System Software	FUJIFILM Healthcare Americas Corporation	LNH	Class II	1999-01-25
K984273	Focus Dailies Visitint (Nelfilcon a) One-Day Contact Lens	Alcon Laboratories	MVN	Class II	1999-01-25
K984257	Medrad Phased Array Neurovascular Coil	Medrad, Inc.	MOS	Class II	1999-01-25
K984252	Imation Trimatic Digital System	Imation Corp.	LMA	Class II	1999-01-25
K984127	Powder Free Latex Examination Gloves, Non-Sterile	Kilang Barangan Getah Dioh	LYY	Class I	1999-01-25
K984069	Entaxis Nasal Packing	Les Laboratorires Brothier, S.A.	EMX	Class I	1999-01-25
K984045	RF Control for Immunoturbidimetric Assays	Kamiya Biomedical Company, LLC	DHR	Class II	1999-01-25
K983905	Kodak Digital Science 3600 Distributed Medical Imager, Kodak Digital Science 1200 Distributed Medical Imager, Model 3600	Eastman Kodak Company	LMC	Class II	1999-01-25
K983832	Interacoustics Model Mt 10, Handheld Impedance Audiometer	Idem (Int'L Dist. of Electronics for Medicine)	ETY	Class II	1999-01-25
K983782	Electrosurgical Dispersive Electrode	Conmedcorp	GEI	Class II	1999-01-25
K982568	Bladdermanager Pci 5000 Model 1002	Diagnostic Ultrasound Corp.	ITX	Class II	1999-01-25
K982432	Pillow Masker, C2007m, C2008m,ce2000, Wonder Ear, Mini Wonder Ear, Pt-2Sm, Pt-3Sm, Pt-3Lfm, Pt-3Hfm, Pt3cm, Pt5-Sm, Pt5-	Tinnitus Treatment Centers, Inc.	KLW	Class II	1999-01-25
K982264	Firstsave Biphasic Models 9200 and 9210	Survivalink Corp.	MKJ	Class III	1999-01-25
K981954	Various Dental Implants with Various Abutments	Healthline Implants, Inc.	NRQ	Class II	1999-01-25
K984577	Drager Oxylog 2000	Drager, Inc.	CBK	Class II	1999-01-22
K984321	Vitros Immunodiagnostic Products Vitamin B12, Reagent Pack 1/2, Folate Reagent Pack 3, Anf Calibrators	Ortho-Clinical Diagnostics, Inc.	CDD	Class II	1999-01-22
K984317	The Aptus (Automated) Application of the Toxoplasma Igg Elisa Test System. an Enzyme Linked Immunosorbent Assay (Elisa)f	Zeus Scientific LLC	LGD	Class II	1999-01-22
K984232	Modification of Emit D.a.u. Opiates Assay	Syva Co.	DJG	Class II	1999-01-22