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 2270 of 3531

510(k) clearances, page 2270 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K933332	Model 6400 Abc Electrosurgery Generator	William E. Mckay	GEI	Class II	1993-09-23
K933146	Esb 2400 Sei	Esb, Inc., Div. of Ray-O-Vac	FTC	Class II	1993-09-23
K932995	Surgical Trocar and Cannula	Applied Medical Resources Corp	GCJ	Class II	1993-09-23
K932839	A Mano Tongue Cleanser	A Mano Products, Ltd.	LCN	Class I	1993-09-23
K932827	Alpha-Dent Core Buildup Paste	Alpha-Dent	EBF	Class II	1993-09-23
K932102	Electrosurgical Electrode	Megadyne Medical Products, Inc	GEI	Class II	1993-09-23
K932045	Disposable Insufflation Tubing	L.A.S.E.R., Inc.	GCJ	Class II	1993-09-23
K931978	Sharplase Short Fiber Nd:yag Delivery System	Sharplan Lasers, Inc.	GEX	Class II	1993-09-23
K931411	Medtronic Model 4081,4581,4582 Target Tip Pacing L	Medtronic, Inc.	DTB	Class III	1993-09-23
K931212	Diomed 25 25W Surgical Diode Laser	Dio-Med Corp.	GEX	Class II	1993-09-23
K931197	Meddev Multarray (Tm) Medical Examination Light	Meddev International Corp.	KZF	Class I	1993-09-23
K930557	Latex Examination Glove	Ezmt Valve Co., Inc.	LYY	Class I	1993-09-23
K930420	Hunter Air Cleaners Model Nos. 30100/30250/30300	Hunter Fan Co.	FRF	Class II	1993-09-23
K930151	Omni-Matrix	Innovative Technology, Ltd.	JEP	Class I	1993-09-23
K926103	Polyp Snare Net W/monopolar Cautery	United States Endoscopy Group, Inc.	GEI	Class II	1993-09-23
K926002	Alamar Bacterial Identification Test Panel	Alamar Biosciences Laboratory, Inc.	JSS	Class I	1993-09-23
K925866	Cenator Total Hip System	Corin Orthopedic Products	JDI	Class II	1993-09-23
K925691	Insufflation Tubing	Mectra Labs, Inc.	HIF	Class II	1993-09-23
K923201	Endosi Suction Irrigator	Armm, Inc.	GCJ	Class II	1993-09-23
K922859	Anatomical Type Knee System	Osteo Technology, Inc.	JWH	Class II	1993-09-23
K921666	Cardiac Theraphy System Scp 900	Ppg Hellige B.V.	LDD	Class II	1993-09-23
K933781	Anti-Disconnection Mechanism	Hammer-Plane, Inc.	CBH	Class I	1993-09-22
K933188	Dade (Pai-1) Chromogenic Assay Dade Coagtrol-Pai	Baxter Diagnostics, Inc.	JPA	Class II	1993-09-22
K932468	Novus Multiwavelength	Coherent Medical Group	GEX	Class II	1993-09-22
K931644	Gertie Marx Needle	Intl. Medical-Dental Products USA, Inc.	BSP	Class II	1993-09-22
K931218	Intropeel V	Menlo Care, Inc.	DYB	Class II	1993-09-22
K930801	Intropeel	Menlo Care, Inc.	DYB	Class II	1993-09-22
K930639	On-Line Analysis System	Softheart, Inc.	DQK	Class II	1993-09-22
K930194	Hemostasis Valve and Tubing Set	Opticon Medical, Inc.	DYB	Class II	1993-09-22
K923702	Intima Point Guard Intravascular Catheter	Becton Dickinson Vascular Access, Inc.	FOZ	Class II	1993-09-22
K923406	Bioscope	BIOTRONIK AG	DPS	Class II	1993-09-22
K922838	Norodyn 2000 Electromyograph	Noromed, Inc.	HCC	Class II	1993-09-22
K932879	G C II Agar with Sensivitalex	Becton Dickinson Microbiology Systems	JSO	Class II	1993-09-21
K932178	Aia-Pack Pa Calibration Verification/linearity Tes	Tosoh Medics, Inc.	JJX	Class I	1993-09-21
K932159	Systemate Direct Bilirubin Cat. No. 65406	Em Diagnostic Systems, Inc.	CIG	Class II	1993-09-21
K932009	The Samuels Retrograd Valvulotome	Vascutech, Inc.	MGZ	Class II	1993-09-21
K931939	Olympus Creatinine Reagent	Olympus Corp.	CGX	Class II	1993-09-21
K931786	Ace Clinical Chemistry System	Schiapparelli Biosystems, Inc.	JJE	Class I	1993-09-21
K931441	Fenwal 40 Micron Transfusion Filter	Baxter Healthcare Corporation	FPB	Class II	1993-09-21
K930734	Cedia Valporic Acid Assay	Microgenics Corporation	LEG	Class II	1993-09-21
K930554	The Natural-Knee Revision	Intermedics Orthopedics	JWH	Class II	1993-09-21
K930304	Cobas Core Fsh Eia	Roche Diagnostic Systems, Inc.	CGJ	Class I	1993-09-21
K930108	Rmhs Porous Distal Sleeve	Smith & Nephew Richards, Inc.	JDI	Class II	1993-09-21
K924714	Bard Urodynamic Catheter	C.R. Bard Inc	FEN	Class II	1993-09-21
K924474	Selby Instrumentation	Advanced Spine Fixation Systems, Inc.	KWP	Class II	1993-09-21
K922841	Biopro Modular Tibial Tray	Biopro, Inc.	JWH	Class II	1993-09-21
K933874	Spectacle Frame	Designer Frames	HQZ	Class I	1993-09-20
K933754	Chenoweth-Frank Radiopathological Grid	Cook, Inc.	IZH	Class II	1993-09-20
K933734	Marchon/marcolin Sunglasses	Marchon Eyewear, Inc.	HQY	Class I	1993-09-20
K933616	Multiple	Greg and Greg, Inc.	HQY	Class I	1993-09-20