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 1862 of 3531

510(k) clearances, page 1862 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K973179	Feminique Sonic Hair Remover	Global TV Concepts, Ltd.	KCX	Class I	1997-10-30
K973174	Sonique Hair Remover	Global TV Concepts, Ltd.	KCX	Class I	1997-10-30
K973051	Drager-Vapor 19.1 W/plug System S Plus	Draeger, Inc.	CAD	Class II	1997-10-30
K972924	Surgic II Implant Control Unit	Nsk Nakanishi, Inc.	EBW	Class I	1997-10-30
K972885	Servo-Control Wall-Mount Cosycot Infant Warmer Model Iw960, Manual Control Wall-Mount Cosycot Infant Warmer Model Iw970	Fisher & Paykel Electronics, Ltd.	FMT	Class II	1997-10-30
K972878	Ultrasafe Injection System Needle Guard, Models B50,b100l,b150,b225, and B300	Safety Syringes, Inc.	FMF	Class II	1997-10-30
K972848	Narkomed MRI Anesthesia System	Draeger, Inc.	BSZ	Class II	1997-10-30
K972842	Interpore Inducer Bone Graft Delivery Syringe	Interpore Intl.	LYC	Class II	1997-10-30
K972648	Sonicsys Inlay	Ivoclar North America, Inc.	EIH	Class II	1997-10-30
K970638	Cts Midcab Fixedn Diameter Coronary Shunt	Cardiothoracic Systems, Inc.	DXC	Class II	1997-10-30
K964661	Hx-20/21-1 Endoscopic Ligator	OLYMPUS Corporation of the Americas	MND	Class II	1997-10-30
K973911	2 Gallon Alternate Care Sharps Container	Sage Products LLC	FMI	Class II	1997-10-29
K973894	Immusure	Quantimetrix Corp.	JJY	Class I	1997-10-29
K973846	Air Conduction Hearing Aid	Baron Trading, Inc.	ESD	Class I	1997-10-29
K973843	Msi Pressure Infusor	Smith Assoc.	KZD	Class I	1997-10-29
K973634	Coulter Ac.t Diff Analyzer	Coulter Corp.	GKZ	Class II	1997-10-29
K973550	Tuttnauer Table-Top Autoclave	Tuttnauer USA Co. Ltd.	FLE	Class II	1997-10-29
K973345	Matrix Plus Multi-Calibrator Kit	Verichem Laboratories, Inc.	JIX	Class II	1997-10-29
K973297	Cosman Coagulator (Cc-1) System	Radionics, Inc.	GEI	Class II	1997-10-29
K973196	Zeus Scientific, Inc., Anti-Cardiolipin Iga Elisa Reagents	Zeus Scientific LLC	MID	Class II	1997-10-29
K973173	Powerstar Bipolar Scissors	Ethicon, Inc	GEI	Class II	1997-10-29
K972984	Lerner Medical, Inc. Autoclavable 10 Mm Laparoscope	Lerner Medical, Inc.	GCJ	Class II	1997-10-29
K972864	Duration Stabilized Uhmwpe Knee Comp., Wear Claims	Howmedica Corp.	JWH	Class II	1997-10-29
K972863	Duration Stabilized Uhmwpe Knee Components	Howmedica Corp.	JWH	Class II	1997-10-29
K972757	Royal Shield Non-Sterile Powderfree, Colored Nitrile Examination Glove	Shield Gloves Manufacturer (M) Sdn Bhd	LZA	Class I	1997-10-29
K972551	Artisan Pulse Lavage System	Howmedica Corp.	FQH	Class II	1997-10-29
K972352	The Meretek Ubt Breath Test for H.pylori	Meretek Diagnostics, Inc.	MSQ	Class I	1997-10-29
K972292	Solidex	Shofu Dental Corp.	EBF	Class II	1997-10-29
K971690	Immunoscan Pr3-Anca	Svar Life Science AB	MOB	Class II	1997-10-29
K971689	Immunoscan Anti-Myeloperoxidase Antibodies (Mpo-Anca) Quantitative Kit	Svar Life Science AB	MOB	Class II	1997-10-29
K971649	Ksea Arthropump Plus	Karl Storz Endoscopy-America, Inc.	HRX	Class II	1997-10-29
K971514	Regent Biogel Diagnostic Procedure Glove	London International Group, Inc.	LYY	Class I	1997-10-29
K971464	Immunoscan Anti-Gbm Quantitative Kit	Svar Life Science AB	DBL	Class II	1997-10-29
K970230	Sporox	Reckitt Benckiser LLC	MED	Class II	1997-10-29
K970162	Neurological Endoscope	Richard Wolf Medical Instruments Corp.	GWG	Class II	1997-10-29
K970143	C4	Clinicon Corp.	GEX	Class II	1997-10-29
K973948	Dualine 100 Bte	Bernafon-Maico, Inc.	ESD	Class I	1997-10-28
K973579	Am Series Hearing Aid	A & M Hearing, Ltd.	ESD	Class I	1997-10-28
K973431	Lasette	Cell Robotics, Inc.	GEX	Class II	1997-10-28
K973422	Lasershare Print Spooler(2100[solaris X86]/(1500[windows Nt])	Dejarnette Research Systems	LMC	Class II	1997-10-28
K973156	Ubi Magiwel Cocaine Metabolites	United Biotech	DJG	Class II	1997-10-28
K973155	Ubi Magiwel Opiate Metabolites	United Biotech	DJG	Class II	1997-10-28
K973153	Ubi Magiwel Amphetamine Metabolites	United Biotech	DJG	Class II	1997-10-28
K973090	Medstation	Program S.r.l.	LMD	Class I	1997-10-28
K973028	Helios Laser Imager 1417	Sterling Diagnostic Imaging, Inc.	LMC	Class II	1997-10-28
K972905	Xplan-1	Radionics Software Applications, Inc.	IYE	Class II	1997-10-28
K972872	Derma K Laser System	Esc Medical Systems, Ltd.	GEX	Class II	1997-10-28
K972829	Cricket 2000 Recording Pulse Oximeter	Respironics, Inc.	DQA	Class II	1997-10-28
K972353	Erco-Ribbon	Ercons, Inc.	LKY	Class II	1997-10-28
K972271	North American Scientific (Nasi) I-125 Radionuclide Brachytherapy Source- Model Med 3631-a	Ml Strategies, Inc.	KXK	Class II	1997-10-28