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 1715 of 3531

510(k) clearances, page 1715 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K991281	Electric Mobility Cavalier Scooters	Electric Mobility	INI	Class II	1999-10-27
K990233	St-302 Infrarex	Skylark Device Co., Ltd.	ILY	Class II	1999-10-27
K984465	Oxyconalpha with Option ECG	Erich Jaeger, Inc.	LOS		1999-10-27
K983613	Pre-Powdered Non-Sterile Vinyl Examination Gloves	Shanghai Jiatai Plastic Products Co., Ltd.	LYZ	Class I	1999-10-27
K983000	Cricothyrotomy Tube	Polamedco, Inc.	BTO	Class II	1999-10-27
K993175	Gold Core 75	Jeneric/Pentron, Inc.	EJT	Class II	1999-10-26
K993173	Gold Core 55	Jeneric/Pentron, Inc.	EJT	Class II	1999-10-26
K992926	Ginram Endocic Single Oval Port (Model No. 720195)	Ri Mos. S.r.l.	HHK	Class II	1999-10-26
K992544	Transvaginal Hydro Laparoscopy (Thl) System	Circon Corp.	HEX	Class II	1999-10-26
K992522	Spectrum Designs Spectragel	Spectrum Designs, Inc.	MDA	Class I	1999-10-26
K992097	Endorez	Ultradent Products Inc.	KIF	Class II	1999-10-26
K982521	Skintact ECG Electrodes, S&w ECG Electrodes	Leonhard Lang GmbH	DRX	Class II	1999-10-26
K993345	K-Assay Apo Ai	Kamiya Biomedical Company, LLC	DER	Class II	1999-10-25
K993341	Intellisystem II Color Monitor	Merit Medical Systems, Inc.	MAV	Class II	1999-10-25
K993294	Diamedix Is-Ana Elisa Screen Test System	Diamedix Corp.	LKJ	Class II	1999-10-25
K993211	Piccolo Sodium Test System	Abaxis Inc	JGS	Class II	1999-10-25
K993009	Hydrocision Arthrojet System with Cautery	Hydrocision, Inc.	HRX	Class II	1999-10-25
K992902	Ambu Hand Power Suction Pump	Ambu, Inc.	BSY	Class I	1999-10-25
K992858	Abbott Axsym Homocysteine	Abbott Medical	LPS	Class II	1999-10-25
K992837	3.5 Mm 90 Cannulated Limited Contact Angeled Blade Plates (3.5Mm 90 Cannulated Lc-Abp)	Synthes (USA) Products LLC	KTW	Class II	1999-10-25
K992796	Aspiration/irrigation Catheter, Model Ac-1000	Image-Guided Neurologics, Inc.	HCA	Class II	1999-10-25
K992760	Select-Sutter Micro Bipolar Forceps	Select Medizintechnik Hermann Sutter GmbH	GEI	Class II	1999-10-25
K992698	Stentor, Pageview	Philips North America LLC	LMD	Class I	1999-10-25
K992628	Firstclass Power Tilt and Recline Seat System, Model S400	Teftec Corp.	ITI	Class II	1999-10-25
K992627	First Class Power Recline Seating System, Model S500	Teftec Corp.	ITI	Class II	1999-10-25
K992619	Amigo Model 680000 (Amigo Excite F 350)	Amigo Mobility Intl., Inc.	ITI	Class II	1999-10-25
K992603	Xrt 600 r/f, Wrf 0600	Wuestec Medical, Inc.	JAA	Class II	1999-10-25
K992269	Ventil-a Oral Protector	Somatics, LLC	JXL	Class II	1999-10-25
K991970	Scarease Sheets & Scarease Gel	Pillar Surgical, Inc.	MDA	Class I	1999-10-25
K991853	Interacoustics Ep 15 Abr Stand Alone Unit	Idem (Int'L Dist. of Electronics for Medicine)	GWJ	Class II	1999-10-25
K991696	Stryker Hermes-Ready Total Performance System	Stryker Corp.	DZI	Class II	1999-10-25
K991543	Intraop Catheter	Halyard Health	MEB	Class II	1999-10-25
K991456	Microwave Delivery System, Model Mmc-300	Microwave Medical, Inc.	MWY	Class II	1999-10-25
K991385	Dade Behring N High Sensitivity Crp Assay	Siemens Healthcare Diagnostics Inc.	DCK	Class II	1999-10-25
K991140	Oratec Interventions Vulcan Eas Electrothermal Arthroscopy System and Accessories	Oratec Interventions, Inc.	GEI	Class II	1999-10-25
K990397	Flexible Fiberscopes & Accessories	Richard Wolf Medical Instruments Corp.	HRX	Class II	1999-10-25
K990023	Hybrid Capture II CT-Id Test	Qiagen	LSK	Class I	1999-10-25
K993265	Soring Gmbh, Arco 3000, Arco 2000, Arco 1000, Mbc 601, Mbc 600	Soring GmbH Medizintechnik	GEI	Class II	1999-10-22
K993220	Puritan-Bennett Helios Portable Liquid Oxygen System	Medtronic, Inc.	BYJ	Class II	1999-10-22
K993212	Dryasol Acid Concentrate Mix	Diasol, Inc	KPO	Class II	1999-10-22
K993181	Howmedica Osteonics Accp System Cortical Screws	Howmedica Osteonics Corp	KWQ	Class II	1999-10-22
K992629	D/sense II (Green-or) Dentin Desensitizer	Centrix, Inc.	LBH	Class II	1999-10-22
K992519	Nrc Non-Rinse Conditioner	Dentsply Intl.	EBC	Class II	1999-10-22
K992471	Sims Portex Epidural Catheter, 20G Model# 4910-16/17; 21G Model# 4910-18	Abbott Medical	BSO	Class II	1999-10-22
K991026	Reflection Crosslinked Uhmwpe Acetabular Components	Smith & Nephew, Inc.	LPH	Class II	1999-10-22
K990793	Accuguide Muscle Injection Monitor	Medtronic Xomed, Inc.	GXZ	Class II	1999-10-22
K990713	Spectranetics Lead Locking Device (Lld) #1, #2, #3 Lister	Spectranetics Corp.	DRB	Class II	1999-10-22
K990637	Synthes Locking Reconstruction Plate (Lrp) with Condylar Head	Synthes (USA) Products LLC	NEI	Class II	1999-10-22
K984313	Htu3	Hyox Systems, Ltd.	CBF	Class II	1999-10-22
K983627	Venture Iho 100 Home Fill Complete Home Oxygen System	Invacare GmbH	CAW	Class II	1999-10-22