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 1098 of 3531

510(k) clearances, page 1098 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K083847	Marvel Pediatric Wheelchair	Rogue Wheelchairs, Inc.	IOR	Class I	2009-01-30
K083771	Retcam Portable Ophthalmic Imaging System, Model Rcp	Clarity Medical Systems	HKI	Class II	2009-01-30
K083717	Powder Free Nitrile Examination Gloves, Bubble Gum Scented, Pink	Gx Corporation Sdn Bhd	LZA	Class I	2009-01-30
K083635	Smith & Nephew Biosure Pk Interference Screw	Smith & Nephew Endoscopy, Inc.	MBI	Class II	2009-01-30
K083496	Camlog Implant System Modified Implants and Abutments	Altatec GmbH	DZE	Class II	2009-01-30
K083464	Premier Campy, Model 618096	Meridian Bioscience Inc	LQP	Class I	2009-01-30
K083286	Orthopediatrics Pediloc Locking Plate System	Orthopediatrics Corp	HRS	Class II	2009-01-30
K083258	Medilas D Family Lasers, Including Medilas D Litebeam, Litebeam +, Urobeam, Multibeam, Flexipulse and Magnapulse	Dornier Medtech America, Inc.	GEX	Class II	2009-01-30
K083226	Smith & Nephew Peek Interference Screw	Smith & Nephew Endoscopy, Inc.	MBI	Class II	2009-01-30
K083059	Air Sonic Scaler	DPM USA Corp.	ELC	Class II	2009-01-30
K083040	S-Test C-Reactive Protein (Crp)	Alfa Wassermann Diagnostic Technologies, Inc.	DCN	Class II	2009-01-30
K082866	Revolutionfull Face Mask	Respironics Inc., Sleep & Home Respiratory Group	BZD	Class II	2009-01-30
K082482	Fora Td-4251/U-Right Td-4252/U-Right Td-4254 Blood Glucose Monitoring System, Model Td-4251/Td-4252A/td-4252B/td-4254	Taidoc Technology Corporation	CGA	Class II	2009-01-30
K081153	Novel Spinal System	Medyssey Co., Ltd.	MNH	Class II	2009-01-30
K080782	Niti-S Esophageal Stent	Taewoong Medical Co., Ltd.	ESW	Class II	2009-01-30
K080513	Qlaser System	2035, Inc.	NHN	Class II	2009-01-30
K080117	Patient Isolation Unit, Model G019-1000	Gentex Corporation	LGM	Class II	2009-01-30
K083915	Angelite Family of Intense Pulsed Light Systems, Models Angelite-Ddc and Angelite-Sdc	Advanced Technology Laser Co., Ltd.	GEX	Class II	2009-01-29
K083904	Asahi Suoh Ptca Guide Wire	Asahi Intecc Co., Ltd.	DQX	Class II	2009-01-29
K083574	Relieva Stratus Microflow Spacer	Acclarent Inc	KAM	Class I	2009-01-29
K083319	Fully Automatic Electronic Blood Pressure Monitor, Model Kd-7941	Andon Health Co., Ltd	DXN	Class II	2009-01-29
K083318	Fully Automatic Electronic Blood Pressure Monitor, Model Kd-5904	Andon Health Co., Ltd	DXN	Class II	2009-01-29
K083317	Fully Automatic Electronic Blood Pressure Monitor, Model Kd-5902	Andon Health Co., Ltd	DXN	Class II	2009-01-29
K083248	Fully Automated Electronic Blood Pressure Monitor, Model Kd-7902	Andon Health Co., Ltd	DXN	Class II	2009-01-29
K083247	Fully Automated Electronic Blood Pressure Monitor, Model Kd-7906	Andon Health Co., Ltd	DXN	Class II	2009-01-29
K083246	Fully Automated Electronic Blood Pressure Monitor, Model Kd-5961	Andon Health Co., Ltd	DXN	Class II	2009-01-29
K082973	Ster-Mate Sterile Lavage Kit	Dentsply Interntional	ELC	Class II	2009-01-29
K082852	Bd Phoenix Automated Microbiology System-Nitrofurantoin (Gp) 4-128 Ug/ml	Becton Dickinson & Co	LON	Class II	2009-01-29
K082035	Maico Mb 11 with Beraphone Probe	MAICO Diagnostics GmbH	GWJ	Class II	2009-01-29
K081548	Anterior Buttress Plate	Scien'Tx USA, Inc.	KWQ	Class II	2009-01-29
K073593	I2s Doppler Probe ( 6 Hour), I2s Doppler Probe (24 Hour), I2c Doppler Probe (72 Hour), Models 9090-7015, 9090-7016	Deltex Medical Limited	DPT	Class II	2009-01-29
K090045	Color Lcd Monitor, Radiforce Rx320	Eizo Nanao Corporation	LLZ	Class II	2009-01-28
K090009	Thd Slide One	Thd SpA	JAF	Class II	2009-01-28
K083865	Pilot Spinal System	Life Spine	MNI	Class II	2009-01-28
K083618	Pacs Scan	Pacsgear, Inc.	LLZ	Class II	2009-01-28
K083528	Smith & Nephew Bipolar Adapter Cable, Model 72200022	Smith & Nephew, Inc.	GEI	Class II	2009-01-28
K083323	Nuvo Verde LED Lighting System	Nuvo, Inc.	FSY	Class II	2009-01-28
K083297	Pitt-Easy Dental Implant System	Sybron Implant Solutions GmbH	DZE	Class II	2009-01-28
K083279	Caltrix Resorbable Bone Void Filler	Ag Digital Technology Corp.	MQV	Class II	2009-01-28
K081846	Grebset Micro-Introducer Kit, Models 7950, 7951	Vascular Solutions LLC	DQO	Class II	2009-01-28
K083617	Apieron Insight Eno System	Apieron, Inc.	MXA	Class II	2009-01-27
K083337	Nugard, Sensiflex Procedure Examination Gloves	Terang Nusa (Malaysia) Sdn. Bhd.	LYY	Class I	2009-01-27
K083209	Acrylic Herbst Splint Appliance	Specialty Appliances, LLC	LRK	Class II	2009-01-27
K082799	Hds Hi 1.54	Paragon Vision Sciences, Inc.	HQD	Class II	2009-01-27
K082754	Aequalis Humeral Nail System	TORNIER Inc.	HSB	Class II	2009-01-27
K082504	Apollo Anterior Cervical Plate System	Apollo Spine, Inc.	KWQ	Class II	2009-01-27
K081878	Lemaitre Tt Tortuous Tracker Introducer Catheter Delivery System	LeMaitre Vascular Inc.	DQY	Class II	2009-01-27
K081787	Camlab Cranial Orthosis Helmet	Biosculptor Corporation	OAN	Class II	2009-01-27
K083874	Galaxy	Respironics Inc., Sleep & Home Respiratory Group	MNR	Class II	2009-01-26
K083718	Beau Rx Scar Care Gel	Beau RX Solutions, LLC	MDA	Class I	2009-01-26