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 2152 of 3531

510(k) clearances, page 2152 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K944783	Sun Eyewear Company, Multiple Brand Names	Sun Eyewear Co.	HQY	Class I	1994-10-27
K944394	Sunglasses	Unique Industries, Inc.	HQY	Class I	1994-10-27
K944243	Cardiochex	Cala Diagnostics	JJT	Class I	1994-10-27
K944178	Bivona Flextend Pediatric & Neonatal Tracheostromy Tubes	Bivona Medical Technologies	JOH	Class II	1994-10-27
K943407	Gentamicin 120 Ug, Streptomycin 30 Ug Sensi-Disc Suspectibility Tests	Becton Dickinson Microbiology Systems	JTN	Class II	1994-10-27
K943313	Phenytoin Fpia Reagent Set and Calibrators	Sigma Diagnostics, Inc.	LGR	Class II	1994-10-27
K943235	Immulite Digitoxin	Siemens Healthcare Diagnostics Inc.	LFM	Class II	1994-10-27
K943228	Microsporidium Control Set	Meridian Diagnostics, Inc.	LJG	Class I	1994-10-27
K941496	Solarcare Total Protein Micro-Plate Assay	Solarcare, Inc.	CEK	Class II	1994-10-27
K941291	Monoject Samplette Separator Tube	Sherwood Medical Co.	GIO	Class I	1994-10-27
K925909	Genesis 1, Automated Cell Counter, Modification	Alicia Diagnostics, Inc.	GKZ	Class II	1994-10-27
K925510	Model 90478 & 90479 Telemetry Rec. Module&housing	GE Healthcare	DSI	Class II	1994-10-27
K943673	Mmc Amplifier	Melville Software, Ltd.	GWL	Class II	1994-10-26
K941492	Pressure Relief Valve	Circulatory Technology, Inc.	MNJ	Class II	1994-10-26
K936127	Howmedica Premium Femoral Component	Howmedica Corp.	JDI	Class II	1994-10-26
K934238	Mule	Penny and Giles Biometrics, Ltd.	ISD	Class II	1994-10-26
K930964	Acuson Model #29001 (Diagnostic Ultrasound Device)	Acuson Corp.	IYO	Class II	1994-10-26
K944556	4 Channel Dispenser	Tecan U.S.	JQW	Class I	1994-10-25
K944426	Biosign, Accusign, Lifesign, Hcg Serum/urine	Princeton BioMeditech Corp.	JHI	Class II	1994-10-25
K943252	Pro-Step Lh Ovulation Prediction Test	Disease Detection International, Inc.	CEP	Class I	1994-10-25
K943076	Quanta Lite Ena 5 Elisa Kit	Inova Diagnostics, Inc.	LLL	Class II	1994-10-25
K944723	Antimicrobial Susceptibility Test Panel Modification	Alamar Biosciences, Inc.	JWY	Class II	1994-10-21
K944537	Scimed Triguide Guide Catheter	Scimed Life Systems, Inc.	DQY	Class II	1994-10-21
K944326	Philips Tomoscan Sr5000	Philips North America LLC	JAK	Class II	1994-10-21
K944078	Program 3-Ch Ser Hear Aids W/program Fit Syst/pro Fit	Argosy Electronics	ESD	Class I	1994-10-21
K943993	Cedia Dau Amphetamines Assay	Microgenics Corporation	DKZ	Class II	1994-10-21
K943460	Portarem 2000	Starkey Laboratories, Inc.	ETW	Class II	1994-10-21
K943459	Deskrem-1000	Starkey Laboratories, Inc.	ETW	Class II	1994-10-21
K943370	Impulse Sealer Product Line	Ultradent Products Inc.	EJI	Class II	1994-10-21
K941652	Aloka Ssd-2000 Diagnostic Ultrasound System Modification	Aloka Co., Ltd.	IYN	Class II	1994-10-21
K941579	Modified Micro Test Multi Microbe Medium (M5)	Microtest	JSM	Class I	1994-10-21
K935427	R and D Batteries	R & D Batteries, Inc.	JAF	Class II	1994-10-21
K934915	Acuson Model 2001	Acuson Corp.	IYN	Class II	1994-10-21
K933801	Electrode, Cutaneous	Cadwell Laboratories, Inc.	GXY	Class II	1994-10-21
K926463	Rittermodel 75 Evolution Univ Pow Exam Table/acces	Midmark Corp	FQO	Class I	1994-10-21
K926376	Mion 525	Mion International Corp.	EMA	Class II	1994-10-21
K944838	Widex Model Lx-Ite	Widex Hearing Aid Co., Inc.	ESD	Class I	1994-10-20
K944772	Multiple Ed1600 Series Radiation Shields	Image Diagnostics, Inc.	EAK	Class I	1994-10-20
K944706	Reda Laparoscopic Instruments Ger-Main Prime Endo Laparoscopic Instruments	Reda Instrumente GmbH	GEI	Class II	1994-10-20
K944502	Beltone Concerto S	Beltone Electronics Corp.	ESD	Class I	1994-10-20
K944129	Imagyn Laparoscopic Instruments	Imagyn Medical, Inc.	HET	Class II	1994-10-20
K944089	Avl Opti Ph/blood Gas Analyzer	Avl Scientific Corp.	CHL	Class II	1994-10-20
K943996	Dupont Aca Plus Luteinizing Hormone (Lh) Method	Dupont Medical Products	CEP	Class I	1994-10-20
K943960	UV Cured Methyl Methacrylate Hearing Aid Shell Materials	Miracle-Ear, Inc.	ESD	Class I	1994-10-20
K943941	Safestart Vascular Access Start Kit	Becton Dickinson Vascular Access, Inc.	LRS	Class II	1994-10-20
K943784	Melafocon A/rigid Gas Perm Contact Len for Daily Wear	Menicon Co. Ltd.	HQD	Class II	1994-10-20
K943732	Life Trace Fetal Spiral Electrode with Maternal Reference	Graphic Controls Corp.	HGP	Class II	1994-10-20
K943701	Mrx Microplate Reader	Dynatech Laboratories, Inc.	JJQ	Class I	1994-10-20
K943687	Fedelity F495, Viennatone Alpp II	Starkey Laboratories, Inc.	ESD	Class I	1994-10-20
K943472	Cohort Avb Retractor System	Cohort Medical Products Group, Inc.	HXB	Class I	1994-10-20