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 2026-10-22, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 2834 of 3529

510(k) clearances, page 2834 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K870845	Warsaw Orthopedic Pointed Reamer	Warsaw Orthopedic, Inc.	HTO	Class I	1987-03-11
K870503	Hearing Aid, Unitron Model Um60	Unitron Industries, Inc.	ESD	Class I	1987-03-11
K870435	Model 350 Wireless Cros/cros Low Output Hear. Aid	Telex Communications, Inc.	ESD	Class I	1987-03-11
K870434	Model 350 Wireless Bicros/multicros Hearing Aids	Telex Communications, Inc.	ESD	Class I	1987-03-11
K870380	Model 78534C Monitor/terminal W/options A03	Hewlett-Packard Co.	DPS	Class II	1987-03-11
K870350	Escort Ec Custom in-the-Ear Hearing Aid	Hearing Tech, Inc.	ESD	Class I	1987-03-11
K870338	Model Ms-II Ministim	Life-Tech Intl., Inc.	BXN	Class II	1987-03-11
K870053	Torquedriver Wrench	Jerome Medical	HXC	Class I	1987-03-11
K870024	Pontallor 4 Dental Alloy	Degussa Dental, Inc.	EJT	Class II	1987-03-11
K864279	Spacelabs Model 90419 Pulse Oximeter Module	Spacelabs, Inc.	DQA	Class II	1987-03-11
K863674	Tracets 2000/Electrodes	Lectec Corp.	DRX	Class II	1987-03-11
K863630	Austenal Acupac 20 Denture Base Material	Austenal Dental, Inc.	EBI	Class II	1987-03-11
K853194	Era-20	Biotronik Sales, Inc.	DTE	Class II	1987-03-11
K870734	Teflon Biopsy Catheter W/tip Angle	Van-Tec, Inc.	KNW	Class II	1987-03-10
K870732	Rat Liver Nuclei Test System	Val Tech Diagnostics, Inc.	DHN	Class II	1987-03-10
K870697	Van-Tec One Step Ureteral Dilatation Catheter	Van-Tec, Inc.	EZN	Class II	1987-03-10
K870695	Van-Tec Urethral Dilatation System	Van-Tec, Inc.	KOE	Class II	1987-03-10
K870694	Van-Tec Open Ended Cone Tip Ureteral Catheter	Van-Tec, Inc.	KOD	Class II	1987-03-10
K870556	Van-Tec C-Flex Suprapubic Balloon Catheter Set	Van-Tec, Inc.	KOB	Class II	1987-03-10
K870555	Van-Tec Pediatric Suprapubic Catheter Set	Van-Tec, Inc.	KOB	Class II	1987-03-10
K870520	Tandem(r)-M Fsh Immunoenzymetric Assay	Hybritech, Inc.	CGJ	Class I	1987-03-10
K870462	Easy-Test Creatine Kinase-Mb (Ck-Mb) #16615	Em Diagnostic Systems, Inc.	CGS	Class II	1987-03-10
K870259	Vis-Cube Hcg (Eia) Lyophilized Jpl-044	Leeco Diagnostics, Inc.	JHI	Class II	1987-03-10
K870155	Directigen Meningitis Combo Test & (B) Strep Test	BD Becton Dickinson Vacutainer Systems Preanalytic	GTZ	Class I	1987-03-10
K870145	External Y Valve 5C4198	Travenol Laboratories, S.A.	KDJ	Class II	1987-03-10
K865086	Williams Flexible Cystoscopic Injection Needle	Van-Tec, Inc.	FBK	Class II	1987-03-10
K865057	Tandemr Iconr II Hcg(serum) Immunoenzymetric Assay	Hybritech, Inc.	JHI	Class II	1987-03-10
K865032	Cardiofax-V ECG-834Oa	Nihon Kohden America Inc	DSI	Class II	1987-03-10
K865030	Cardiofax-V ECG-8240A	Nihon Kohden America Inc	DSI	Class II	1987-03-10
K864985	Dispos Gel External Pacing Electrode/low Impedance	Medac, Inc.	DRO	Class II	1987-03-10
K864970	Terumo Dental Needles	Terumo Medical Corp.	DZM	Class I	1987-03-10
K864942	Bicarbonate Mixing System	Morris Tool, Ltd.	KPO	Class II	1987-03-10
K864874	Segura Dretler Basket	Van-Tec, Inc.	FFL	Class II	1987-03-10
K864858	Lifesound(tm) Esophageal Stethoscope W/thermistor	Biomedical Concepts, Inc.	BZT	Class II	1987-03-10
K864812	Diasonics Spa 3.5 Mhz, 30Mm Probe	Diasonics, Inc.	ITX	Class II	1987-03-10
K864758	Diasonics Spa 5.O 27Mm Probe	Diasonics, Inc.	ITX	Class II	1987-03-10
K864731	Ocean Scientific Vdrl Test	Ocean Scientific, Inc.	GMQ	Class II	1987-03-10
K863223	Dimension-Wbg	Dimension Diagnostics	CGA	Class II	1987-03-10
K861543	Cardiomax-II	Columbus Instruments Intl. Corp.	DXG	Class II	1987-03-10
K870781	Acromed Wallie-Heinig Disector/elevators	Buckman Co., Inc.	GEG	Class I	1987-03-09
K870780	Acromed Wallie-Heinig Osteotomes	Buckman Co., Inc.	HWM	Class I	1987-03-09
K870779	Acromed Wallie-Heinig Trochar	Buckman Co., Inc.	HWJ	Class I	1987-03-09
K870778	Acromed Wallie-Heinig Curettes	Buckman Co., Inc.	HTF	Class I	1987-03-09
K870727	Warsaw Orthopedic I Bone Plate	Warsaw Orthopedic, Inc.	KTW	Class II	1987-03-09
K870668	Driver-Bender-Extractor, Bone Pin	Military Engineering, Inc.	HXW	Class I	1987-03-09
K870661	Lifewatch Plus	Revvity Health Sciences, Inc.	BZQ	Class II	1987-03-09
K870618	Various Types of Surgical Garments	Kin Yuh Hung Co., Ltd.	FYF	Class I	1987-03-09
K870617	Various Tyes of Surgical Garments	Greene International Corp.	FYF	Class I	1987-03-09
K870523	Hawkins Breast Localization Needle	N-S Medical Products	GDM	Class I	1987-03-09
K870275	Companion 2800 Portable Volume Ventilator	Medtronic, Inc.	CBK	Class II	1987-03-09