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 1409 of 3531

510(k) clearances, page 1409 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K040184	Dideco Micro 40 Ph.i.s.i.o. Adult Arterial Filter	LivaNova USA, Inc.	DTM	Class II	2004-02-26
K033689	Osstell Mentor Rfa	Integration Diagnostics, Ltd.	EKX	Class I	2004-02-26
K033479	Prospect Clostridium Difficile Toxin A/b Microplate Assay	Remel, Inc.	LLH	Class I	2004-02-26
K033086	Neosoothe Polymer Coated Powder-Free Polychloroprene Patient Examination Gloves with Aloe	PT. Medisafe Technologies	LZA	Class I	2004-02-26
K032625	Orthodontic Composite Bracket System	Ultradent Products Inc.	DYW	Class II	2004-02-26
K032555	3M Color Medical Flat Panel Display, Ccl316	Totoku Electric Co., Ltd.	LLZ	Class II	2004-02-26
K032274	Cook Five Lumen Central Venous Catheter	Cook Inc.	FOZ	Class II	2004-02-26
K031097	Polaris Pressure Adjustable Valve System Modes Spv, Spva, Spvb	Sophysa	JXG	Class II	2004-02-26
K030722	Envoy Patient Monitor	Mennen Medical, Inc.	MHX	Class II	2004-02-26
K022894	Epicor Medical Ablation System	Epicor Medical, Inc.	NTB	Class II	2004-02-26
K040326	Autoquant Plus	Philips North America LLC	KPS	Class II	2004-02-25
K040214	Modification to: Masimo Set Radical Pulse Oximeter with Satshare and Lnop Series of Sensors and Cables	Masimo Corporation	DQA	Class II	2004-02-25
K040183	Bisx	Aspect Medical Systems, Inc.	OLW	Class II	2004-02-25
K040157	Elecsys C-Peptide Calcheck	Roche Diagnostics GmbH	JJX	Class I	2004-02-25
K033988	Goldway Ut4000a Vital Signs Monitor	Goldway (Us), Inc.	MWI	Class II	2004-02-25
K033981	Smith & Nephew Electrothermal 20S Spine Generator, Model 7209975	Smith & Nephew, Inc.	GEI	Class II	2004-02-25
K033940	Microscan Dried Gram-Negative Mic/combo Panels-Amoxicillin/clavulanate Potassium (Augmentin)	Siemens Healthcare Diagnostics Inc.	LTT	Class II	2004-02-25
K033717	Transet Fracture Fixation System	Bonutti Research, Inc.	HTY	Class II	2004-02-25
K033395	Codman Dural Graft Implant, Models 80-1471, 80-1472, 80-1473, 80-1474, 80-1475, 80-1476, 80-1477, 80-1478, 80-1480, 80-1	Cerenovus, Inc.	GXO	Class II	2004-02-25
K033352	Vertebron Pss Pedicle Screw System	Vertebron, Inc.	MNI	Class II	2004-02-25
K033259	Light Age Q-Clear Laser, Model 701-1101	Light Age, Inc.	GEX	Class II	2004-02-25
K033232	Colorado Microdissection Needle	Stryker Corp.	GEI	Class II	2004-02-25
K033053	Alveolus, Tb-Sts Tracheobronchial Stent System	Alveolus, Inc.	JCT	Class II	2004-02-25
K040309	Digital Blood Pressure Monitor, Model Ds-1862	Nihon Seimitsu Sokki Co., Ltd.	DXN	Class II	2004-02-24
K040305	Vitrea2 Version 3.5	Canon Medical Informatics, Inc.	LLZ	Class II	2004-02-24
K040249	Skintact ECG Electrode	Leonhard Lang GmbH	DRX	Class II	2004-02-24
K040219	Cobra Surgical Probe	Boston Scientific Corporation	GEI	Class II	2004-02-24
K040176	Maxter Powder Free Nitrile Medical Examination Gloves	Maxter Glove Manufacturing Sdn Bhd	LZA	Class I	2004-02-24
K033996	Hermes	3M Espe AG Dental Products	EBF	Class II	2004-02-24
K033767	Dual Top Anchor System Screws	Jeil Medical Corporation	DZE	Class II	2004-02-24
K033723	Disposable Powdered Vinyl Patient Examination Gloves	Baoding Guanzhong Glove Co., Ltd.	LYZ	Class I	2004-02-24
K033650	Acunav 90/10 Diagnostic Ultrasound Catheter	Siemens Medical Solutions USA, Inc.	OBJ	Class II	2004-02-24
K033564	Powder Free Latex Surgeons Gloves Polymer Coated Sterile with Optional Labeling Claim of E.p. Less Than 50 Ug/dm2	Kanam Latex Industries Pvt. Ltd.	KGO	Class I	2004-02-24
K033030	Calysto Series IV Patient Care Monitors and Central Station and ECG Management System	Invivo Corporation	MWI	Class II	2004-02-24
K032888	Creation Nm Diagnostic Catheters	Neich Medical (Shenzhen) Company Limited	DQO	Class II	2004-02-24
K040272	Synthes (USA) Craniofacial Plates	Synthes (USA) Products LLC	JEY	Class II	2004-02-23
K040166	Depuy Sigma Xlk Tibial Inserts	Depuy Orthopaedics Inc.	JWH	Class II	2004-02-23
K040091	Linical Esoterics Calibration Verifiers Levels a-E for Olympus Au Systems	Cliniqa Corporation	JJY	Class I	2004-02-23
K033820	Microlife Digital Infrared Forehead Thermometer, Model Fr1dm1	Microlife Intellectual Property GmbH	FLL	Class II	2004-02-23
K033812	Siroair L Air Scaler	Sirona Dental Systems GmbH	EFB	Class I	2004-02-23
K033749	Titanium Cannulated Interference Screw	Advanced Biomaterials	HWC	Class II	2004-02-23
K033724	Nobel Biocare Centric Post, Models 31234, 31235 and 31236	Nobel Biocare Uas, Inc.	NHA	Class II	2004-02-23
K033678	Spectranetics Quick Cross Catheters, Models 518-032, 518-033, 518034, 518-035, 518-036, 518-037 and 518-038	Spectranetics Corp.	DQY	Class II	2004-02-23
K040319	Sinon Power Wheelchair, Sn-W401	Sinon Corporation	ITI	Class II	2004-02-20
K040251	Ge Logiq 9 Diagnostic Ultrasound System, Model 2404587	GE Med. Systems Ultrasound & Prim. Care Diag.,Llc	IYN	Class II	2004-02-20
K040221	Servo-I Ventilator System, Model 64 87 800 E407e	Maquet Critical Care AB	CBK	Class II	2004-02-20
K040212	Trigen Intertan	Smith & Nephew, Inc.	JDS	Class II	2004-02-20
K040199	Osse-Lign, 1.5Mm Cocr and Ss Cable System and Components	Osseus, LLC	JDQ	Class II	2004-02-20
K040151	Oasis Biliary Stent Introduction System	Wilson-Cook Medical Inc.	FGE	Class II	2004-02-20
K040137	Wilson-Cook Usw Cap and Wire Lock	Wilson-Cook Medical Inc.	OCY	Class II	2004-02-20