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 2366 of 3531

510(k) clearances, page 2366 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K921772	Biolor	Degussa AG	EJT	Class II	1992-07-13
K921750	Cvis Insight III System	Cardiovascular Imaging Systems, Inc.	ITX	Class II	1992-07-13
K921711	Flexion Distration Support	Altoona Medical Supply	ILZ	Class I	1992-07-13
K921446	Hot or Cold Pack (Thermipaq)	Thermionics Corp.	IME	Class I	1992-07-13
K921444	Digi Sportlens System	Fitness Quest, Inc.	HQY	Class I	1992-07-13
K921260	Laparoscopic Surgical Instrumetns	Jana Medical	GCJ	Class II	1992-07-13
K920959	Insufflator, Laparoscopic	Mectra Labs, Inc.	HIF	Class II	1992-07-13
K920943	Fdp Plasma Test Kit	American Bioproducts Co.	DAP	Class II	1992-07-13
K920795	0R 160, or-1.60, and Orcolite 1.60 High Index	Optical Radiation Corp.	HQG	Class I	1992-07-13
K920701	Industrial Strength Eyewear	Grafix Marketing Group	HQY	Class I	1992-07-13
K920177	Versa-Vial	Bioteque America Inc	DQF	Class II	1992-07-13
K915636	Glove Check Patient Examination Glove Leak Detect.	Associated Ent., Inc.	LDQ		1992-07-13
K912437	Irrigating Syringe	BD Becton Dickinson Vacutainer Systems Preanalytic	FMF	Class II	1992-07-13
K922748	Guedel Airway	Oem Medical Div.	CAE	Class I	1992-07-10
K922736	Kodak Amerlite Tsh-30 Ultrasensitive Standard Sera	Eastman Kodak Company	JLW	Class II	1992-07-10
K922676	Cortisol Chemiluminescence Assay	Nichols Institute	CGR	Class II	1992-07-10
K922597	Olympus Urea Nitrogen (Bun) Reagent	Olympus Corp.	CDQ	Class II	1992-07-10
K922468	Angel Wing Sets -- Modified	Mbo Laboratories, Inc.	GIM	Class II	1992-07-10
K922392	Ite, Itc, Oe(open), Hs(half Shell) Hearing Aid	A-1 Hearing Aid Lab	ESD	Class I	1992-07-10
K922313	P-Link	Virtual Imaging, Inc.	KPS	Class II	1992-07-10
K922284	Elegance Ft4 Elisa	Bioclone Australia Pty, Ltd.	CEC	Class II	1992-07-10
K922233	Olympus Calcium Reagent	Olympus Corp.	CIC	Class II	1992-07-10
K922072	Kodak Ektachem 250 Analyer	Eastman Kodak Company	JJE	Class I	1992-07-10
K922046	Lyphochek Unassayed Chemistry Control Level 3	Bio-Rad	JJY	Class I	1992-07-10
K921992	Mp3000 Series III Video Imager	International Imaging Electronics	LMC	Class II	1992-07-10
K921676	Columnmate II	Helena Laboratories, Corp.	LCP	Class II	1992-07-10
K921520	Vacutainer Brand Luer Adapter	BD Becton Dickinson Vacutainer Systems Preanalytic	JKA	Class II	1992-07-10
K921205	Dsl Active Aldosterone (Dsl 8600)	Diagnostic Systems Laboratories, Inc.	CJM	Class II	1992-07-10
K920543	MRI Oe 1.5 Si	Otsuka Electronics Co., Ltd.	LNH	Class II	1992-07-10
K920096	Mrt-150 Qd Knee Coil	Toshiba America Mri, Inc.	LNH	Class II	1992-07-10
K915791	Coritaxic Multi-Modal Stereotaxi Workstation	Coritechs, Inc.	HAW	Class II	1992-07-10
K915493	Premier Coccidioides	Meridian Diagnostics, Inc.	MIY	Class II	1992-07-10
K914743	Emergency Percutaneous Cricothyroidotomy Kit,modif	Pertrach	BTO	Class II	1992-07-10
K922762	Roche Reagent for Uric Acid--Modification	Roche Diagnostic Systems, Inc.	KNK	Class I	1992-07-09
K922735	Ziess Endoprobe	Carl Zeiss, Inc.	HQB	Class II	1992-07-09
K922290	Single-Step Pregnancy, Hcg Test	American Medical Products LLC	JHI	Class II	1992-07-09
K920272	Oriel	Truphatek, Ltd.	HLJ	Class II	1992-07-09
K920020	Cardio-Card ECG Management System	Nasiff Assoc., Inc.	DPS	Class II	1992-07-09
K922375	Excel Duopulse Model 3000 Combination Ho/er:yag	Excel Tech., Ltd.	GEX	Class II	1992-07-08
K921933	O Butment Hb	O Co., Inc.	DZE	Class II	1992-07-08
K921922	Grice Laparoscopic Suturing Needle	Ideal Medical, Inc.	GCJ	Class II	1992-07-08
K921866	Luminous 250 Fiberoptic Illuminator	Progressive Dynamics, Inc.	HBI	Class II	1992-07-08
K921842	Cynosure Photgenica V Cutaneous Vas. Lesion Laser	Cynosure, LLC	GEX	Class II	1992-07-08
K921799	Patient Examination Gloves	Consolex Corp. Sdn. Bhd.	LYY	Class I	1992-07-08
K921651	Microline Screen for Phencyclidine	Drug Screening Systems, Inc.	LCM	Unclassified	1992-07-08
K921199	Epistaxis Nasal Balloon Catheter	Smith & Nephew Richards, Inc.	EMX	Class I	1992-07-08
K920967	Zeiss Multi Yag Laser	Carl Zeiss, Inc.	GEX	Class II	1992-07-08
K920702	Toxoplasma Gondii (Toxo) Igm Enzyme-Linked Immuno	Pharmacia Diagnostics, Inc.	LGD	Class II	1992-07-08
K915312	Modification Puritan Benett Companion 2801 Vol Ven	Medtronic, Inc.	CBK	Class II	1992-07-08
K915183	Sarns 8000 Modular Perfusion System	3M Health Care, Sarns	DTQ	Class II	1992-07-08