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 1805 of 3531

510(k) clearances, page 1805 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K973979	Multi-Stim TENS, Ap-101081T	Apex Medical, Inc.	GZJ	Class II	1998-07-29
K973978	Micro II Microcurrent TENS	Apex Medical, Inc.	GZJ	Class II	1998-07-29
K971340	Olympus Neuro Endoscope	Olympus Optical Co., Ltd.	GWG	Class II	1998-07-29
K981951	CT 100 Electrocardiograph	Macquarie Medical Systems	DPS	Class II	1998-07-28
K981918	Urea	Abbott Medical	CDQ	Class II	1998-07-28
K981827	Ves 0281-M Complete Video Endoscopic Video System	Angiolaz, Inc.	FET	Class II	1998-07-28
K981721	C0-Axial Introducer Needle	Inrad	KNW	Class II	1998-07-28
K981683	Huber Needle Infusion Set Model #20G01 & Y-Site Model #20G01y	Venusa Ltd.	FPA	Class II	1998-07-28
K981675	Powderfree Green Nitrile Examination Gloves (Polymer Coated)	Besglove Medicare Sdn. Bhd.	LZA	Class I	1998-07-28
K981674	Powdered Green Nitrile Examination Gloves	Besglove Medicare Sdn. Bhd.	LZA	Class I	1998-07-28
K981673	Powderfree Green Nitrile Examination Gloves	Besglove Medicare Sdn. Bhd.	LZA	Class I	1998-07-28
K981631	Influence Clip System	Influence, Inc.	FZP	Class II	1998-07-28
K981618	Liquid a	Harry J. Bosworth Co.	EMA	Class II	1998-07-28
K981601	California Medical Laboratories Inc. Malleable Vent Catheter	Corcym Inc.	DWF	Class II	1998-07-28
K980158	Myo-Train V (5)	Sterne Equipment Co., Ltd.	IPF	Class II	1998-07-28
K980094	Modification to the Oxyconalpha	Erich Jaeger, Inc.	BTY	Class II	1998-07-28
K982048	Mps Reservoir Bag	Medical Product Specialists	KPE	Class II	1998-07-27
K981692	Meniscal Repair Device	Linvatec Corporation	MBI	Class II	1998-07-27
K981434	Eup-Ol334 Laparascopicprobe	Hitachi Medical Corp. of America	ITX	Class II	1998-07-27
K980526	Photon Radiosurgery System Prs400	Pec Photoelectron Corp.	JAD	Class II	1998-07-27
K973636	Mcs-Medicated Canal Sealer	Dr. Howard Martin, P.A.	EMA	Class II	1998-07-27
K974445	3M Red Dot Resting EKG Electrode, Catalog 2360	3M Healthcare	DRX	Class II	1998-07-26
K982232	Modification of the Ibi-1100 Steerable Electrophysiology Catheter System	Irvine Biomedical. Inc.	DRF	Class II	1998-07-25
K982118	Careside Analyzer	Exigent Diagnostics, Inc.	CHH	Class I	1998-07-24
K981963	Sensitex Examination Glove	Oak Carolina, Inc.	LYZ	Class I	1998-07-24
K981804	Xenon Light Source Model Ls6000	Contec Medical Vision, Ltd.	GCT	Class II	1998-07-24
K981774	Medi-Plus, Health-Plus, Sanitex, Reliance	Pwa Industries Sdn. Bhd.	LYY	Class I	1998-07-24
K981741	Carriazo Barraquer Microkeratome	Moria SA	HMY	Class I	1998-07-24
K981736	Bact/alert 3D Microbial Detection System	bioMerieux, Inc.	MDB	Class I	1998-07-24
K981561	Liquid Enzyme Id 90133	Alcon Laboratories	LPN	Class II	1998-07-24
K981511	Oto Wizzard	Medrx, Inc.	EWO	Class II	1998-07-24
K981112	Mobetron	Intraop Medical Corp.	LHN	Class II	1998-07-24
K980128	Baladi Inverter with Coaxial Aortic Punch	Cardio Medical Solutions, Inc.	DXC	Class II	1998-07-24
K972817	Resor-Pin Resorbable Membrane Pin	Geistlich Pharma AG	LYC	Class II	1998-07-24
K982269	Clear Hub Spinal Needle 14Ga, 16Ga, 17Ga, 18Ga, 20Ga, 21Ga, 22Ga, 25Ga, 26Ga and 27Ga	Medtronic, Inc.	MIA	Class II	1998-07-23
K981708	Dental Porcelain-Various	Excel Porcelain Products	FLL	Class II	1998-07-23
K981534	Vipercam	Integra Medical	EIA	Class I	1998-07-23
K981078	Transtracheal Augmented Ventilation Oxygen Concentrator Model Number Ttav 1000	Transtracheal Systems	CAW	Class II	1998-07-23
K981071	Ml Microkeratome	Med-logics Inc	HNO	Class I	1998-07-23
K973347	Tsx Prm Pulmonary Resuscitation Monitor	Spiracle Technology	CAP	Class II	1998-07-23
K970681	Altra Nova 200 Hemodialyzer	Althin Medical AB an Affiliate of Baxter Intl	MSF	Class II	1998-07-23
K970679	Altra Flux 200 Hemodialyzer	Althin Medical AB an Affiliate of Baxter Intl	MSF	Class II	1998-07-23
K982290	Chem-Chex Stat (New)	Streck Laboratories, Inc.	JJY	Class I	1998-07-22
K982277	Modification to Stat Profile Phox Blood Gas Analyzer (K980991)	Nova Biomedical Corporation	CHL	Class II	1998-07-22
K982094	Verabond 2	Aalba Dent, Inc.	EJH	Class II	1998-07-22
K982007	Trubyte Denture Bond Denture Bonding Agent	Dentsply Intl.	KLE	Class II	1998-07-22
K981978	Autoldl Cholesterol Reagent Set and Autoldl Cholesterol Calibrator	Horiba Instruments Incorporated	MRR	Class I	1998-07-22
K981943	Dbil	Abbott Medical	CIG	Class II	1998-07-22
K981926	Ethyl Alcohol Clinical Standard Solutions	EMD Millipore Corporation	DLJ	Class II	1998-07-22
K981920	Amm	Abbott Medical	JIF	Class I	1998-07-22