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 1909 of 3531

510(k) clearances, page 1909 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K970894	Vitros Immunodiagnostics Products Total B-Hcg Reagent Pack (Gem.1075), Total B-Hcg Calibrators (Gem.c075)	Johnson & Johnson Clinical Diagnostics, Inc.	DHA	Class II	1997-04-14
K970483	Aqualite Intact Pth	Sealite Sciences, Inc.	CEW	Class II	1997-04-14
K970369	Vista Mini Camera System	Oktas	GCJ	Class II	1997-04-14
K970330	Dade Indirect Imt System with Tco2 Electrode	Dade Intl., Inc.	CEM	Class II	1997-04-14
K970255	Kipp Med i.v. Manifold	The Kipp Group	FPA	Class II	1997-04-14
K970214	3 Dimensional Video Endoscope	Oktas	GCJ	Class II	1997-04-14
K970203	Epix Vt	Empi	GZJ	Class II	1997-04-14
K970194	Proform Cemented Titanium Revision Femoral Component	Globus Medical, Inc.	JDI	Class II	1997-04-14
K970133	Amerigel Ointment	Amerx Health Care Corp.	MGQ	Unclassified	1997-04-14
K964918	Nima Needleless Injectionsite Master Adapter with Posiflow Positive Displacement Feature, and i.v. Sets	Critical Device Corp.	FPA	Class II	1997-04-14
K964900	Rapid Drug Screen	American Bio Medica Corp.	DIO	Class II	1997-04-14
K964849	Arthrocare Dermatologic Electrosurgery System	ArthroCare Corporation	GEI	Class II	1997-04-14
K963708	Herrick Ultimate Punctum Plug	Lacrimedics, Inc.	LZU	Unclassified	1997-04-14
K963501	Herrick Ultimate Punctum Plug	Lacrimedics, Inc.	LZU	Unclassified	1997-04-14
K963063	Snore Tec	Marketing Technologies, Inc.	LRK	Class II	1997-04-14
K962814	Denver Pleural Effusion Shunt with External Pump Chamber	Denver Biomaterials, Inc.	KPM	Class II	1997-04-14
K970911	Lee Plate	Howmedica Leibinger, Inc.	JEY	Class II	1997-04-11
K970563	Olympus Na-10J-1 Aspiration Needle	OLYMPUS Corporation of the Americas	FCG	Class II	1997-04-11
K970453	B. Braun Medical Inc. Transorbent and Thinsite Border Dressing	B.Braun Medical, Inc.	MGQ	Unclassified	1997-04-11
K970278	Microvasive Gold Probe	Boston Scientific Corporation	KNS	Class II	1997-04-11
K970275	Patient Restraints	Fla Orthopedics, Inc.	FMQ	Class I	1997-04-11
K970274	Patient Restraints	Fla Orthopedics, Inc.	FMQ	Class I	1997-04-11
K970273	Patient Restraints	Fla Orthopedics, Inc.	FMQ	Class I	1997-04-11
K970272	Patient Restraint	Fla Orthopedics, Inc.	FMQ	Class I	1997-04-11
K970184	Olympus Ues-20 Electrosurgical System and Its Associated Accessories	OLYMPUS Corporation of the Americas	GEI	Class II	1997-04-11
K970128	Isocam I (Single Head Gamma Camera)/isocam II (Dual Head Gamma Camera)	Park Medical Systems, Inc.	KPS	Class II	1997-04-11
K970123	Dentsply Cavitron Sps Scaler System	Dentsply Intl.	ELC	Class II	1997-04-11
K964867	Hybrid Resin Composite	Parkell, Inc.	KLE	Class II	1997-04-11
K964261	Smf Stainless Steel Bone Screws	Synthes (USA) Products LLC	DZL	Class II	1997-04-11
K964253	Derma 20 Laser System	Esc Medical Systems, Ltd.	GEX	Class II	1997-04-11
K963030	Leibinger Imf Screw	Howmedica Leibinger, Inc.	DZE	Class II	1997-04-11
K961924	Ibi-1100 Steerable Electrophysiology Catheter System	Irvine Biomedical. Inc.	DRF	Class II	1997-04-11
K955653	Venisect Laser Lancet	Venisect, Inc.	GEX	Class II	1997-04-11
K971051	Immulite Thyroid Autoantibody Control Module	Siemens Healthcare Diagnostics Inc.	JJX	Class I	1997-04-10
K970370	Tsk Sterijekt Premium Disposable Hypodermic Needle	TSK Laboratory, Japan	FMI	Class II	1997-04-10
K970185	Sterile Disposable Equipment Magnet Cover	Domico Med-Device, LLC	KKX	Class II	1997-04-10
K964449	Anca Screen Elisa Test System	Zeus Scientific LLC	MOB	Class II	1997-04-10
K964448	Proteinase-3 Igg Elisa Test System	Zeus Scientific LLC	MOB	Class II	1997-04-10
K964446	Myeloperoxidase Elisa Test System	Zeus Scientific LLC	MOB	Class II	1997-04-10
K962937	Cardio Team II	Vision Electronics	DXH	Class II	1997-04-10
K971228	Femtex 100% Cotton Tampons	Regu-Tech Assoc., Inc.	HEB	Class II	1997-04-09
K970965	Midas Rex III Motor and Attachments (Midas III)	Midas Rex Pneumatic Tools, Inc.	ERL	Class II	1997-04-09
K970796	3M Red Dot 2560 & 2570 Monitoring Electrodes	3M Healthcare	DRX	Class II	1997-04-09
K970576	Somnus Model 615 Electrosurgical Generator(model 615)	Somnus Medical Technologies, Inc.	GEI	Class II	1997-04-09
K970492	Intrauterine Insemination and Sonohysterography Catheter	Ackrad Laboratories	LKF	Class II	1997-04-09
K970200	Reliance Pf Femoral Stems	Howmedica Corp.	LZO	Class II	1997-04-09
K964534	Otosilk Otological Graft Dressing	Boston Medical Products, Inc.	NAD	Class I	1997-04-09
K964533	Ebi Spinelink System	Electro-Biology, Inc.	MNH	Class II	1997-04-09
K963801	Pap Brush	Young OU Brush Co.	HHT	Class II	1997-04-09
K962700	Ventricular Catheter Blood Flow Monitoring Probe Kit and Ventraflo Blood Flow Monitoring Probe Kit	Vasamedics, LLC	DPT	Class II	1997-04-09