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 2026-11-09, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,227 of the 176,624 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	2,827

176,624 records, page 1729 of 3533

510(k) clearances, page 1729 of 3533
K number	Device	Applicant	Product code	Class	Decision date
K990766	Cersr Electromyography System	Paraspinal Diagnostic Corp.	IKN	Class II	1999-08-27
K990261	Plus Ceramic Head Prostheses (Alumina and Zirkonia)	Plus Orthopedics	LZO	Class II	1999-08-27
K983800	Dn Acupunture Needles	Sedatelec	MQX	Class II	1999-08-27
K983798	Sedatelec Asp Acupuncture Needles	Sedatelec	MQX	Class II	1999-08-27
K982208	Irl Vasoscan(tm) Intravascular Ultrasound Catheter	Jomed Imaging, Ltd.	ITX	Class II	1999-08-27
K981677	Repose Bone Screw System	Influence, Inc.	LRK	Class II	1999-08-27
K992589	Resolution 5X (Spherical) and Ultra Gel 5X (Toric)(hioxifilcon a) Soft Daily Wear Contact Lens, (Clear & Blue Visibility	Opti-Centre Laboratories	LPL	Class II	1999-08-26
K992397	Accunate-One Step, Accunate-One Step Cassette	Cenogenics Corp.	JHI	Class II	1999-08-26
K992395	Urine Drug Screening Control	Seracare Technology	DIF	Class I	1999-08-26
K992279	Heparin Control Plasma Level 2	Pacific Hemostasis	GGN	Class II	1999-08-26
K992278	Heparin Control Plasma Level 1	Pacific Hemostasis	GGN	Class II	1999-08-26
K992222	Fluoroplastic Ventilation Tubes	Gyrus Ent LLC	ETD	Class II	1999-08-26
K992140	Piccolo Metlyte 7 Reagent Disc	Abaxis Inc	JLB	Class I	1999-08-26
K991925	Pasco Mic and Mic/id Panels	Pasco Laboratories, Inc.	JWY	Class II	1999-08-26
K991854	Osteoplast, Model Pop200	Interpore Cross Intl.	MQV	Class II	1999-08-26
K991847	Thermoflex System	Argomed, Inc.	KNS	Class II	1999-08-26
K991841	Hawkeye Option for Dual-Head Variable Angle Gamma Camera	GE Medical Systems F.I. Haifa	KPS	Class II	1999-08-26
K991670	Silverstein Microwick	Micromedics, Inc.	ETD	Class II	1999-08-26
K992497	Powdered Nitrile Examination Glove, Blue or White (Non-Colored)	Kossan Latex Industries (M) Sdn Bhd	LZA	Class I	1999-08-25
K992496	Powder-Free Nitrile Examination Glove, Blue or White (Non-Colored)	Kossan Latex Industries (M) Sdn Bhd	LZA	Class I	1999-08-25
K992494	Flexiflo Enteral Feeding Tube	Ross Product Div. Abbott Laboratories	KNT	Class II	1999-08-25
K992248	Post Cement Hi-X	Bisco Inc	EBF	Class II	1999-08-25
K992165	Health-Plus, Sanitex, Reliance Powder-Free Latex Examination Glove	Pamitex Industries Sdn Bhd	LYY	Class I	1999-08-25
K992062	Safeskin Sterile Purple Nitrile Examination Gloves	Safeskin Corp.	LZA	Class I	1999-08-25
K991888	Miniject	Spartan Ultrasonics, Inc.	EJI	Class II	1999-08-25
K991823	N-395 Pulse Oximeter, Model N-395	Medtronic, Inc.	DQA	Class II	1999-08-25
K991698	Redi-Test Pcp	Redwood Biotech, Inc.	LCM	Unclassified	1999-08-25
K990777	Med-Rx Extension Sets	Canadian Hospital Specialties Ltd.	FPA	Class II	1999-08-25
K983719	Bioshield Express Sterilization Wrap	Medtronic, Inc.	FRG	Class II	1999-08-25
K992672	Belmont Fluid Management System (Fms2000)	Belmont Medical Technologies	FRN	Class II	1999-08-24
K992663	Aloka Ssd-5500 Diagnostic Ultrasound System	Aloka Co., Ltd.	IYN	Class II	1999-08-24
K992608	Atc Option for Evita 2 Dura and Evita 4	Drager, Inc.	CBK	Class II	1999-08-24
K992477	Rotosnare	Inscope, LLC	FDI	Class II	1999-08-24
K992349	Vitros Immunodiagnostic Products Troponin I Range Verifiers	Ortho-Clinical Diagnostics, Inc.	JJY	Class I	1999-08-24
K992181	Trip Tonometry Catheter, 8F	GE Healthcare	KNT	Class II	1999-08-24
K991942	Autostat II Anti-Gpc Elisa, Hy.tec Anti-Gpc Elisa	Cogent Diagnotics, Ltd.	MLE	Class II	1999-08-24
K990037	Neptune Waste Management System	American Immuno Tech	FYD	Class II	1999-08-24
K992644	Sidexis Digital Radiography Imaging System	Sirona Dental Systems GmbH	MUH	Class II	1999-08-23
K992470	Ultramark 400C/sonoace 6000 Ultrasound System	Advanced Technology Laboratories, Inc.	IYO	Class II	1999-08-23
K992299	Health-Plus, Sanitex, Reliance Pre-Powdered Nitrile Examination Glove	Pamitex Industries Sdn Bhd	LZA	Class I	1999-08-23
K992123	Scimed Impulse Angiographic Catheters	Boston Scientific Corporation	DQO	Class II	1999-08-23
K992107	Baldur Brand Vinyl Powdered Examination Gloves	General Gloves Corp.	LYZ	Class I	1999-08-23
K992104	Parset, Model A10001e	Rd Medical Mfg., Inc.	FPA	Class II	1999-08-23
K991943	Mrgp Optical Tracking Unit	Philips North America LLC	LNH	Class II	1999-08-23
K991896	Mg Atc: Attenuation Correction System for Dual-Head Variable-Angle Gamma Camera	GE Medical Systems F.I. Haifa	KPS	Class II	1999-08-23
K991559	Medline Prohibit Series Surgical Mask with Fluid Shield	MEDLINE INDUSTRIES, LP - Northfield	FXX	Class II	1999-08-23
K991254	Qs Delivery System	Sub-Q, Inc.	KYZ	Class I	1999-08-23
K991007	K-Defib/pace Radiolucent Adult Electrode, Model Krt-60	Katecho LLC	MKJ	Class III	1999-08-23
K980244	Aequalis Shoulder Prosthesis	TORNIER Inc.	KWS	Class II	1999-08-23
K992620	Blulaze	Premier Laser Systems, Inc.	GEX	Class II	1999-08-20