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 1756 of 3531

510(k) clearances, page 1756 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K990552	Immunoglobulin a Test System	Siemens Healthcare Diagnostics Inc.	CFQ	Class II	1999-03-25
K990551	Igg Flex Reagent Cartridge	Siemens Healthcare Diagnostics Inc.	CFQ	Class II	1999-03-25
K990518	Peregrine Wet Set, Model Pd400.00	Peregrine Surgical, LLC.	FRN	Class II	1999-03-25
K990456	Anal 2 Electrode Stimulation/emg Probe - W/stop	Hollister, Inc.	KPI	Class II	1999-03-25
K990438	Dermaflex Wound Dressing, Dermaflex Foam Wound Dressing, Healiaflex Wound Dressing, Healiafoam Wound Dressing	Dermaphylyx, Inc.	MGP	Unclassified	1999-03-25
K990257	Keeler Pulsair 3000 Non Contact Tonometer	Keeler Instruments, Inc.	HKX	Class II	1999-03-25
K990208	Personal Infusor with Drug Disposal Septal Port	Science Incorporated	MEG	Class II	1999-03-25
K990145	Wilson-Cook Bipolar Probe	Wilson-Cook Medical Inc.	KNS	Class II	1999-03-25
K990140	Normed Bone Transport	Ace Surgical Supply Co., Inc.	JEY	Class II	1999-03-25
K990072	Balloon Ureteral Dilators, Accent Dg Balloon Ureteral Dilator Set, Ascend Balloon Dilation Catheters, Balloon Dilation C	Cook Incorporated	EZN	Class II	1999-03-25
K990056	Jeldent Multicryl	J.F. Jelenko & Co., Inc.	EBI	Class II	1999-03-25
K984618	Bci Mini-Torr Plus, Model 6004	Bci Intl., Inc.	DXN	Class II	1999-03-25
K982798	Osteonics Anterior Cervical Compression Plating System	Osteonics Corp.	KWQ	Class II	1999-03-25
K990682	Prophy-Mate Motor Handpiece, Models Prophy-Mate (2000 Rpm Max), Endo-Mate (600Rpm Max.)	Nsk Nakanishi, Inc.	EKX	Class I	1999-03-24
K984062	Seal-Away Hemostasis Adapter, Model 406229	Diag Corp.	DYB	Class II	1999-03-24
K983483	Vascular Occlusion System	Cordis Neurovascular, Inc.	HCG	Class II	1999-03-24
K983272	Ibc Flopump, Model 6000	International Biophysics Corp.	KFM	Class II	1999-03-24
K982136	Jostra Venous Hardshell Cardiotomic Reservoir Vhk 4200	Schiff & Co.	DTN	Class II	1999-03-24
K990772	Directflow Arterial Cannula	Heartport, Inc.	DWF	Class II	1999-03-23
K990751	Southland Powderfree (Polymer-Coated) Latex Examination Gloves	Southland Products Co., Ltd.	LYY	Class I	1999-03-23
K990746	Southland Powderfree Latex Examination Gloves with Protein Label Claim	Southland Products Co., Ltd.	LYY	Class I	1999-03-23
K990691	Hermes Operating Room Control Center	Computer Motion, Inc.	GCJ	Class II	1999-03-23
K990448	The.r.mo.free	Dentamax, Inc.	EBI	Class II	1999-03-23
K990392	Depuy Ace Spider Plate	Depuy Ace Medical Co.	HRS	Class II	1999-03-23
K990291	Lactosorb Bone Pin	Zimmer GmbH	HTY	Class II	1999-03-23
K990013	Evergreen Non-Sterile Powder-Free, Colored Nitrile Examination Gloves	Yty Industry (Manjung) Sdn. Bhd.	LZA	Class I	1999-03-23
K984578	Synergy D2 Spinal Implants	Interpore Cross Intl.	MNI	Class II	1999-03-23
K984494	Randox Albumin	Randox Laboratories, Limited	CIX	Class II	1999-03-23
K984138	Aptus (Automated) Application for the B. Burgdorferi Antibody Elisa Test System	Zeus Scientific LLC	LSR	Class II	1999-03-23
K983986	Conway Stuart Medical Model C4 Electrosurgical Generator	Conway Stuart Medical, Inc.	GEI	Class II	1999-03-23
K983794	Chemo Mini Spike Plus	B. Braun of America, Inc.	LHI	Class II	1999-03-23
K983652	Ablator Electrode	Linvatec Corporation	HRX	Class II	1999-03-23
K983576	Dr180-R/oxy	North East Monitoring, Inc.	FLL	Class II	1999-03-23
K983533	Actiwatch	Mini-Mitter Co., Inc.	GWQ	Class II	1999-03-23
K983346	Standard 0.025 Straight, Standard 0.025 Angled, Standard 0.032 Straight, Standard 0.032 Angled, Soft 0.035 Straight, Sof	Boston Scientific Corporation	DQX	Class II	1999-03-23
K983229	Olympic Medical Lectromed Cerebral Function Monitor System	Olympic Medical Corp.	OMA	Class II	1999-03-23
K980737	Advantage Chemiluminescence Erythropoietin Immunoassay	Nichols Institute Diagnostics	GGT	Class II	1999-03-23
K990780	Nuvolase 532 Cutaneous Laser System	American Laser Medical	GEX	Class II	1999-03-22
K990725	Nuvolase 532 Laser System	American Laser Corp.	GEX	Class II	1999-03-22
K990707	Medtronic 5F & 9F Zuma Guiding Catheters	Medtronics Interventional Vascular	DQY	Class II	1999-03-22
K990557	The Stellar Tilt, Manually Operated Wheelchair	Pdg Product Design Group Inc	IOR	Class I	1999-03-22
K990555	Tisport X and Tisport Xc	TiSport, LLC	IOR	Class I	1999-03-22
K990554	Dimension Special Protein Calibrator	Siemens Healthcare Diagnostics Inc.	JIT	Class II	1999-03-22
K990553	Igm Flex Reagent Cartridge	Siemens Healthcare Diagnostics Inc.	CFQ	Class II	1999-03-22
K990460	Calibrator for Automated Systems (C.f.a.s.)	Roche Diagnostics GmbH	JIX	Class II	1999-03-22
K990393	Architect Progesterone Mastercheck Model #6C26-05	Bio-Rad	JJX	Class I	1999-03-22
K990389	Moss Gastrostomy Tube	Moss Tubes, Inc.	KNT	Class II	1999-03-22
K990334	Ksea Endoscope Holder	Karl Storz Endoscopy-America, Inc.	OCV	Class II	1999-03-22
K990297	Etest Minocycline	Ab Biodisk	JWY	Class II	1999-03-22
K990249	Ovustick Lh Ovulation Predictor, Model 9030, Ovucard Lh Ovulation Predictor, Model 9031	Phamatech Inc.	CEP	Class I	1999-03-22