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 2132 of 3531

510(k) clearances, page 2132 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K940119	Royal Marsden Gold Grain Gun	Best Industries	IWS	Class I	1994-12-30
K935688	An-10S Andersen Tube with Stylet	H.W. Andersen Products, Inc.	BSS	Class II	1994-12-30
K934732	Pelvic Exam Tray	Medcare Custom Packaging, Inc.	HHT	Class II	1994-12-30
K933410	Implant Applicators, Cartridges/magazines, Implanters for Permanent Implant of Radioactive Seeds/sources	Best Industries	IWJ	Class I	1994-12-30
K933384	Bard Hystero-Flo II Pump	Davol Inc., Sub. C.R. Bard, Inc.	HIG	Class II	1994-12-30
K933156	Datex As/3 Patient Monitor	Datex Division Instrumentarium Corp.	DPS	Class II	1994-12-30
K932288	Neonatal Breathing Circuit Modification	Simplex Medical Systems, Inc.	CAI	Class I	1994-12-30
K931473	Impact Model 753	ZOLL Medical Corporation	BTL	Class II	1994-12-30
K945910	Quest 2 and 20	Aalba Dent, Inc.	EJT	Class II	1994-12-29
K945867	R&d Part 5518, 5306, 5315 and 5457	R & D Batteries, Inc.	FCO	Class I	1994-12-29
K945769	Total Etch Gel	Dentsply Intl.	EBF	Class II	1994-12-29
K945723	Opulent 76 and 83	Aalba Dent, Inc.	EJT	Class II	1994-12-29
K945722	Matrx Mdm, Ra	Matrx Medical, Inc.	BSZ	Class II	1994-12-29
K945714	Verabond III	Aalba Dent, Inc.	EJH	Class II	1994-12-29
K945713	Verabond II	Aalba Dent, Inc.	EJH	Class II	1994-12-29
K945712	Verabond V	Aalba Dent, Inc.	EJH	Class II	1994-12-29
K945577	Guardian II Glove	Guardian Group, Inc.	LZC	Class I	1994-12-29
K945539	Optiguard	Sybron Dental Specialties, Inc.	EBF	Class II	1994-12-29
K945401	White Star	Jeneric/Pentron, Inc.	EJT	Class II	1994-12-29
K945364	Dyract(tm) Material	Denstply Detrey-Dedent	EBF	Class II	1994-12-29
K945284	Truject	Clive Craig Co.	FMI	Class II	1994-12-29
K945244	Pulp Canal Sealer Ewt	Sybron Dental Specialties, Inc.	EMA	Class II	1994-12-29
K945190	Sterrad Chemical Indicator Tape	Advanced Sterilization Products	JOJ	Class II	1994-12-29
K944359	Expression Rx-12, Enhancement Rx-34, Elite Rx-12	Rexton, Inc.	ESD	Class I	1994-12-29
K944271	Dental Operative Unit Accesories	Dci Intl.	EIA	Class I	1994-12-29
K944086	Cx(tm) Cannabinoid 50Ng(thc5) Reagent/synchron Cx Sys	Beckman Instruments, Inc.	LDJ	Class II	1994-12-29
K944075	Cx(tm) Barbiturates(barb) Reagent for Synchron Cx Syst	Beckman Instruments, Inc.	DIS	Class II	1994-12-29
K944056	Auto-Lyte Methadone Dia	Solarcare Technologies Corp,Inc.	DJR	Class II	1994-12-29
K943863	Needle Guide	Biopsys Medical, Inc.	IYN	Class II	1994-12-29
K943729	Dye Check Strips 545-630	Awareness Technology, Inc.	JJY	Class I	1994-12-29
K943643	Stat Profile Ultra 11 Analyzer	Nova Biomedical Corporation	CHL	Class II	1994-12-29
K943637	Ssd-2000 Diagnostic Ultrasound System	Aloka Co., Ltd.	ITX	Class II	1994-12-29
K943042	Bun Qvet	Prisma Systems	CDN	Class II	1994-12-29
K943001	Magnesium Qvet	Prisma Systems	JGJ	Class I	1994-12-29
K942997	Alkaline Phosphatase (Alkp) Qvet	Prisma Systems	CJE	Class II	1994-12-29
K942964	Lactate Dehydrogenase Qvet	Prisma Systems	CFJ	Class II	1994-12-29
K942963	Glucose Qvet	Prisma Systems	CFR	Class II	1994-12-29
K940950	Kavo Systematica 1060	Kavo America	KLC	Class I	1994-12-29
K940907	Madden Surgical Thimble	Kelley-Gilmer Medical Corp.	KNA	Class II	1994-12-29
K940261	Lynx Low-Speed Handpiece	Mti Precision Products	EFB	Class I	1994-12-29
K940091	Innova Vaginal EMG Sensing Electrode	Empi	HIR	Class II	1994-12-29
K933873	Concept Universal Pump System	Linvatec Corporation	HIG	Class II	1994-12-29
K933808	EEG Cup Electrode	Cadwell Laboratories, Inc.	GXY	Class II	1994-12-29
K933796	EEG Needle Electrode	Cadwell Laboratories, Inc.	GXZ	Class II	1994-12-29
K931595	Reverse Osmosis Equipment for Water Purification	Osmonics, Inc.	FIP	Class II	1994-12-29
K924850	Vansonnenberg Gastrostomy Catheter	Boston Scientific Corporation	KNT	Class II	1994-12-29
K921682	Zinetics Amc	Zinetics Medical, Inc.	FFX	Class II	1994-12-29
K945866	Cylindrical Sponge	Lorrex Health Products	GDY	Class I	1994-12-28
K945606	Triangular Sponges	Lorrex Health Products	GDY	Class I	1994-12-28
K945553	Round Stick Sponges, Flat Stick Sponges	Lorrex Health Products	GDY	Class I	1994-12-28