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 2263 of 3531

510(k) clearances, page 2263 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K930080	E*net Neuromonitoring System	Physiometrix, Inc.	GWQ	Class II	1993-10-19
K924793	Han-D-Aid	Salmon Ent.	FMI	Class II	1993-10-19
K934120	Non-Prescription Eyeglass Frames & Sunglasses Various Styles	Lux de Paris, Inc.	HQY	Class I	1993-10-18
K934082	Spectacle Frames	South American Optical, Inc.	HQZ	Class I	1993-10-18
K934081	Spectacle Sun Glasses (Non Prescription)	South American Optical, Inc.	HQY	Class I	1993-10-18
K934056	Tri-Point Brand Liquimmune Immunoassay Contr 1,2 & 3	Medical Analysis Systems, Inc.	JJY	Class I	1993-10-18
K934034	Spectacle Sunglasses (Non-Perscription)	H.M.O. Optical, Inc.	HQY	Class I	1993-10-18
K933991	Spectacle Frames	U.S. Optical	HQZ	Class I	1993-10-18
K933956	Aldo's Optical Frame Collection	Frontier Novelty, Inc.	HQZ	Class I	1993-10-18
K933905	Asics Sunglasses	Asics Tiger Corp.	HQY	Class I	1993-10-18
K933891	Spectacle Frames	Euro Frame Design, Inc.	HQZ	Class I	1993-10-18
K933865	Frames	Hillman'S, the Eyecare Co., Inc.	HQZ	Class I	1993-10-18
K933809	Opto Line Srl	Optoline S.r.l.	HQZ	Class I	1993-10-18
K933765	Frame-Spectacle	Clearvision Optical Co., Inc.	HQZ	Class I	1993-10-18
K933718	Mugnier Jerik Sunglasses	Huntley Global Ent.	HQY	Class I	1993-10-18
K933697	Sigma Cre Reagent	Sigma Chemical Co.	CGX	Class II	1993-10-18
K933089	Fashion Italiana Eyewear	Fashion Italiana, Inc.	HQY	Class I	1993-10-18
K932980	Total T4 Fpia Reagent Set/calibrator #T-1039,T-116	Sigma Diagnostics, Inc.	CDX	Class II	1993-10-18
K932768	Cardio Rep Ck Calibrators 1 & 2 Cat. No. 3322 & 3323	Helena Laboratories, Corp.	JIX	Class II	1993-10-18
K932145	Coagulation Reference Plasma, Normal	American Diagnostic Corp.	GIZ	Class II	1993-10-18
K931464	Baxter Coronary Angioscope Inflation Device	Baxter Healthcare Corporation	LYK	Class II	1993-10-18
K931301	Olympus Amylase Reagent	Olympus Corp.	CIJ	Class II	1993-10-18
K931019	Becton Dickinson Locking Safety-Gard(tm) IV Needle	BD Becton Dickinson Vacutainer Systems Preanalytic	FMI	Class II	1993-10-18
K930937	Ld 400	Vismed, Inc.	HPT	Class I	1993-10-18
K930253	Cardio2 Ctcke	Ergometrx, Inc.	ISD	Class II	1993-10-18
K925756	Uni II	Rudolf Riester GmbH & Co. KG	HLJ	Class II	1993-10-18
K925638	Phoenix Disposable Pressure Transducer #73-600	Baxter Healthcare Corporation	DXO	Class II	1993-10-18
K924237	Windmere Prelude III	Windmere Corp.	ISA	Class I	1993-10-18
K933909	Scope Wash	Core Dynamics, Inc.	GCJ	Class II	1993-10-15
K933641	Bld Neonatal Heated Wire Breathing Circuit- 30 Volt Compatible	Bird Life Design	CAI	Class I	1993-10-15
K933559	Alliger Ultrasonic Surgical System	Medsonic, Inc.	LFL	Unclassified	1993-10-15
K933517	Automatic Pull Back Device	Cardiovascular Imaging Systems, Inc.	DQX	Class II	1993-10-15
K933496	Maxima Filtered Hardshell Reservior	Medtronic, Inc.	DTP	Class II	1993-10-15
K933387	Brimfield Precision Grasper/dissector	Springfield Surgical Instruments	GCJ	Class II	1993-10-15
K933322	Zeiss Opmilas 144 Surgical Lasers	Carl Zeiss, Inc.	GEX	Class II	1993-10-15
K932877	Diastat Anti-Centromere Kit	Shield Diagnostics, Ltd.	LLL	Class II	1993-10-15
K932700	Cuto(tm) Tissue Morcellation System	Linvatec Corporation	GEY	Class I	1993-10-15
K932628	Endoscopic Video Camera	Stephen Chakoff, Inc.	FWF	Class I	1993-10-15
K932504	Ri-Former	Rudolf Riester GmbH & Co. KG	HLJ	Class II	1993-10-15
K932421	Surgilase/op 15, 20, 25, 30, 40, 50 CO2 Surg. Lase	Surgilase, Inc.	GEX	Class II	1993-10-15
K932156	Multiline; Dly-1	Derma-Lase Co.	GEX	Class II	1993-10-15
K931828	Carelet Safety Lancet	Gainor Medical Europe, Ltd.	FMK	Class II	1993-10-15
K931787	Zoll Pd 5300	ZOLL Medical Corporation	LDD	Class II	1993-10-15
K931491	Sime Health Sime Hypoallergenic	Sime Health, Ltd.	LYY	Class I	1993-10-15
K931489	Intherm Radially Expanding Dilating Introducer	Innerdyne Medical, Inc.	DYB	Class II	1993-10-15
K931427	Latex Examination Glove Powder Free Formtex	Formtex Medical Sdn. Bhd.	LYY	Class I	1993-10-15
K930250	Low Dead Space Adaptor & Reuasable Airway Adaptor	Pryon Corp.	CCK	Class II	1993-10-15
K926480	Laparoscopic Balloon Retractor	Origin Medsystems, Inc.	GCJ	Class II	1993-10-15
K926297	Reflex Esi	Richard-Allan Medical Ind., Inc.	GEI	Class II	1993-10-15
K926242	Orc Endoscopic Monopolar Electrosurgical Probe	O.R. Concepts, Inc.	GEI	Class II	1993-10-15