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 1930 of 3531

510(k) clearances, page 1930 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K963548	Dentapure Dental Unit Water Line Filter-Iodinated	Mrlb Intl., Inc.	EIA	Class I	1997-01-22
K963480	Multi-Purpose Utility Restraint/body Holder	DeRoyal Industries, Inc.	KID	Class I	1997-01-22
K963476	Disposable Limb Holder	DeRoyal Industries, Inc.	FMQ	Class I	1997-01-22
K963475	Poncho Vest Restraint	DeRoyal Industries, Inc.	KID	Class I	1997-01-22
K963474	Tuxedo Vest Restraint	DeRoyal Industries, Inc.	FMQ	Class I	1997-01-22
K963468	Restrictive Limb Holder	DeRoyal Industries, Inc.	FMQ	Class I	1997-01-22
K963380	Co 2 Smo Plus	Novametrix Medical Systems, Inc.	BZC	Class II	1997-01-22
K963339	Coherent Ultrapulse CO2 Surgical Lasers	Coherent Medical Group	GEX	Class II	1997-01-22
K963322	Olympus,jasmine,jimmy-O Raincoat,drink,ares,aphrodite,zeus,apollo,selfcare,careplus,titan	Custom Services Intl., Inc.	LTZ	Class II	1997-01-22
K963321	Olympus,jasmine,jimmy-O Raincoat,drink,ares,aphrodite,zeus,apollo,selfcare,careplus,titan	Custom Services Intl., Inc.	HIS	Class II	1997-01-22
K963319	Olympus,jasmine,jimmy-O Raincoat,drink,ares,aphrodit,zeus,apollo,selfcare,careplus,titan	Custom Services Intl., Inc.	HIS	Class II	1997-01-22
K963304	Stryker Tempest Orthopedic Pump	Stryker Corp.	HRX	Class II	1997-01-22
K963282	Seraquest Hsv Igg	Quest Intl., Inc.	LGC	Class II	1997-01-22
K963263	Tetraone System for Epics Xl Flow Cytometry Systems and Cyto-Stat Tertrachrome Cd45-Fitc/cd4-Rdi/cd8-Ecd/cd3-Pc5	Coulter Corp.	GKZ	Class II	1997-01-22
K962999	Safety Injection System	Integritech, Inc.	EJI	Class II	1997-01-22
K962857	Coag-a-Mate Mtx	bioMerieux, Inc.	GKP	Class II	1997-01-22
K962564	Richards Total/partial Prosthesis	Gyrus Ent LLC	ETB	Class II	1997-01-22
K962251	Medoff Sliding Plate (Proposed Name)	Wrightmedicaltechnologyinc	KTT	Class II	1997-01-22
K961847	Hemashield Vantage (Vascular Graft	Meadox Medicals, Div. Boston Scientific Corp.	DSY	Class II	1997-01-22
K961002	Diasonics Itnraoperative Probes	Diasonics Ultrasound	ITX	Class II	1997-01-22
K955023	Brentwood Pc-ECG	Brentwood Medical Products, Inc.	DSI	Class II	1997-01-22
K954717	Sodem High Speed System for Neurosurgery & Median Sternotomy	Sodem Diffusion SA	HBB	Class II	1997-01-22
K964995	Sas One-Step Pregnancy	SA Scientific, Ltd	JHI	Class II	1997-01-21
K964748	Elecsys Prolactin Assay	Boehringer Mannheim Corp.	CFT	Class I	1997-01-21
K964639	Telex in-the-Ear Custom Hearing Aid with Threshold Compression-II	Telex Communications, Inc.	ESD	Class I	1997-01-21
K964574	Affirm One-Step Professional Pregnancy Test	Athena Medical Corp.	JHI	Class II	1997-01-21
K963500	Glucometer Dex Diabetes Care System	Bayer Corp.	CGA	Class II	1997-01-21
K962796	Neuroguard Transcranial Doppler Ultrasound System	Medasonics, Inc.	IYN	Class II	1997-01-21
K961508	Immunocard H. Pylori	Meridian Diagnostics, Inc.	LYR	Class I	1997-01-21
K954214	Cep X Spectrumorange\y Spectrumgreen DNA Probe Kit	Vysis	OXP	Class II	1997-01-21
K965157	Cedia Dau Multi-Drug Control Cedia Dau Specialty Control Set 1	Boehringer Mannheim Corp.	DIF	Class I	1997-01-17
K965126	Ast/sgot	Derma Media Lab., Inc.	CIT	Class II	1997-01-17
K965013	Digiscope Rx-2 (9 Option)	Medirex, Inc.	OXO	Class II	1997-01-17
K964856	Cd3 Fitc/cd19 R-Pe/cd45 Tri-Color Monoclonal Antibody Combination	Caltag Laboratories, Inc.	GKZ	Class II	1997-01-17
K964816	Audina 153 Behind the Ear and Audina 158 Behind the Ear	Audina Hearing Instrument, Inc	ESD	Class I	1997-01-17
K964772	Aquarius Hpf (Will Be Sold as Williams Classic Visions)	Ivoclar North America, Inc.	EJT	Class II	1997-01-17
K964586	Prescott's Light Source Model No. II-150	Iba/Griffith	FCW	Class II	1997-01-17
K964583	Xrt-7.0	Elscint, Inc.	JAK	Class II	1997-01-17
K964548	Apex Universal Drive System	Linvatec Corporation	ERL	Class II	1997-01-17
K964430	Pulpdent Snoop	Pulpdent Corporation	LFC	Class II	1997-01-17
K964330	Biohorizons Dental Implant System (Name Subject to Change)	BioHorizons Implant Systems Inc	DZE	Class II	1997-01-17
K964327	Ipu Rx-2	Medirex, Inc.	LLZ	Class II	1997-01-17
K964306	Magnetic Resonance Diagnostic Accessory	General Electric Co.	LNH	Class II	1997-01-17
K964304	Osteonics Spinal System-Toploading Transverse Connector Assembly	Osteonics Corp.	MNH	Class II	1997-01-17
K963872	Femrx Morcellator System	Gynecare Innovation Center	HET	Class II	1997-01-17
K963695	Immulite Anti-Tpo-Ab(lktoi,lkt05,lktoz	Siemens Healthcare Diagnostics Inc.	JZO	Class II	1997-01-17
K963535	Sigma Diagnostics Glucose Reagent	Sigma Diagnostics, Inc.	CGA	Class II	1997-01-17
K962648	Ohmeda Model 5330 Anesthetic Agent Monitor	GE Healthcare	CBQ	Class II	1997-01-17
K962404	Siemens Sc 6000 & Sc 6000 P Portable Bedside Monitoring System	Siemens Medical Solutions USA, Inc.	DSI	Class II	1997-01-17
K962175	Portex Adjustable Flange Tracheostomy Tube	Smiths Industries Medical Systems, Inc.	JOH	Class II	1997-01-17