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 1931 of 3531

510(k) clearances, page 1931 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K962153	Digital Image Analysis System	University of Washington	LLZ	Class II	1997-01-17
K962075	Hsw Gmbh Arthroscope	Henke Sass Wolf of America, Inc.	HRX	Class II	1997-01-17
K961642	Medilog Mr95	Oxford Instruments, PLC.	GWQ	Class II	1997-01-17
K961638	Medilog Mpa-S	Oxford Instruments Medical Systems	OLV	Class II	1997-01-17
K961636	Medilog Vision	Oxford Instruments, PLC.	OLZ	Class II	1997-01-17
K961275	Sirius 10, 10L, 40, 40L	Micro-Mega Societe Anonyme	EFB	Class I	1997-01-17
K960685	Orthodoc Preoperative Planner Model 500	Integrated Surgical Systems, Inc.	HWT	Class I	1997-01-17
K964848	Wallace Artificial Insemination Catheter - 8Cm/18cm	Marlow Surgical Technologies, Inc.	MFD	Class II	1997-01-16
K964601	Cusa System 200C Ultrasonic Aspirator/cusa System 200T Ultrasonic Aspirator/cusa Lap Accessory	Medtronic, Inc.	LFL	Unclassified	1997-01-16
K964581	Sofsilk	United States Surgical, A Division of Tyco Healthc	GAP	Class II	1997-01-16
K964362	Kinamed Profix System	Kinamed Inc	HRS	Class II	1997-01-16
K964350	Modula Options for Severe Bone Loss and Trauma	Intermedics Orthopedics	JDI	Class II	1997-01-16
K964258	Instruments for Endoscopic Subfascial Discision of Perforating Vins Esdp, Model 8781	Richard Wolf Medical Instruments Corp.	GCJ	Class II	1997-01-16
K963930	Cts Midcab/svh Bipolar Scissors	Cardiothoracic Systems, Inc.	GEI	Class II	1997-01-16
K962632	Omnipulse/omnipulse-Max	Trimedyne, Inc.	GEX	Class II	1997-01-16
K960508	Pathway Electromyograph Model Pathway Ii/mr-10/Mr-15/Mr-20/Mr-25	The Prometheus Group	HIR	Class II	1997-01-16
K950099	Synergy(tm) Ti Posterior Spinal System	Buckman Co., Inc.	MNH	Class II	1997-01-16
K964991	700-Fr Series Radiolucent Stimulation Electrodes	Cardiotronics Systems, Inc.	MKJ	Class III	1997-01-15
K964560	Bhi W/vancomycin Agar	Hardy Diagnostics	JSO	Class II	1997-01-15
K964527	N Rheumatology Standard Sl	Behring Diagnostics, Inc.	JIX	Class II	1997-01-15
K964275	Alpha Posterior Spinal System	Sofamor Danek USA,Inc.	KWP	Class II	1997-01-14
K964249	Bridge Long Stem Femoral Component	Wrightmedicaltechnologyinc	LZO	Class II	1997-01-14
K964227	Metal Acetabular Component	Encore Orthopedics, Inc.	LPH	Class II	1997-01-14
K964154	Segue Infusion Catheter	Interventional Innovations Corp.	KRA	Class II	1997-01-14
K963424	Olympus Lipase Reagent	OLYMPUS Corporation of the Americas	CDT	Class I	1997-01-14
K962223	Water Chambers for St 3000 Heated Humidifier	Marquest Medical Products, Inc.	BTT	Class II	1997-01-14
K962220	Heated Wire Circuits for Sct 3000 Heated Humidifier	Marquest Medical Products, Inc.	BZE	Class II	1997-01-14
K962144	Phoenix Ete Tissue Extension System	Phoenix Biomedical Corp.	MKY	Class I	1997-01-14
K943230	Mayo Hip Prosthesis	Mayo Clinic	LPH	Class II	1997-01-14
K965171	Liquichek Urianlysis Control (Cat. No. 420,421,422,425,426)	Bio-Rad	JJY	Class I	1997-01-13
K964950	La Plata 28 (Pm-28)	Gateway Alloys, Inc.	EJT	Class II	1997-01-13
K964949	Aurora 53	Gateway Alloys, Inc.	EJT	Class II	1997-01-13
K964948	Aurora 52 (Pm-01)	Gateway Alloys, Inc.	EJT	Class II	1997-01-13
K964941	El Dorado 40	Gateway Alloys, Inc.	EJT	Class II	1997-01-13
K964940	Taos 28	Gateway Alloys, Inc.	EJT	Class II	1997-01-13
K964682	Skyway	Kid'S Wheel-Chairs	IOR	Class I	1997-01-13
K964587	Vancomycin Assay or the Technicon Immuno 1 System	Bayer Corp.	LEH	Class II	1997-01-13
K964457	Roche Cobas Ibtegra Reagent Cassettes	Roche Diagnostic Systems, Inc.	JQB	Class I	1997-01-13
K964403	Simplicity Tm Electric/battery Breast Pump Kit (1068)	The First Years, Inc.	HGX	Class II	1997-01-13
K964348	Aia-Pack B12 Assay	Tosoh Medics, Inc.	CDD	Class II	1997-01-13
K964331	Asc High Pressure Braided Tubes	Adam Spencer Corp.	DQO	Class II	1997-01-13
K963663	11F Guiding Catheter	Boston Scientific /International Technologies	DQY	Class II	1997-01-13
K963092	Maxi-Torque Plus Softip Angiographic Catheter	Adam Spencer Corp.	DQO	Class II	1997-01-13
K962914	Rep 3 Quto-Flur Cholesterol-30	Helena Laboratories, Corp.	JHO	Class I	1997-01-13
K962873	Cep 12 Spectrumorange Direct Labeled Chromosome Enumeration DNA Probe	Vysis	OVQ	Class II	1997-01-13
K962458	Cadwell Four-/Eight-Channel Preamplifier	Cadwell Laboratories, Inc.	GWF	Class II	1997-01-13
K962457	Two-Channel Preamplifier	Cadwell Laboratories, Inc.	GWF	Class II	1997-01-13
K962455	Four-Channel Preamplifier	Cadwell Laboratories, Inc.	GWF	Class II	1997-01-13
K962438	Misty Ox Turboheater	Vital Signs, Inc.	CAF	Class II	1997-01-13
K962179	Stat Im 5000 Cassette Autoclave	Scican Ltd.	FLE	Class II	1997-01-13