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 2949 of 3529

510(k) clearances, page 2949 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K853403	Storz Diamond Knife	Storz Instrument Co.	HNN	Class I	1985-11-04
K853353	88000 Gastrostomy-Jejunal Feeding Tube Kit	Superior Healthcare Group, Inc.	KNT	Class II	1985-11-04
K853063	Smartknife System	CooperVision, Inc.	HNN	Class I	1985-11-04
K852828	Beaver R-K Knife	Rudolph Beaver, Inc.	HNN	Class I	1985-11-04
K852706	Versablade	Alphamedix, Inc.	HNN	Class I	1985-11-04
K852633	Versablade	Alphamedix, Inc.	HNN	Class I	1985-11-04
K854306	Ohmeda Cpu Air Compressor Model 3350	GE Healthcare	BTI	Class II	1985-11-01
K854143	Battery Insulator for Use W/implantable Pacemakers	Telectronics, Inc.	DXY	Class III	1985-11-01
K854120	Murray Chair Lift	J.B. Murray Enterprises, Inc.	FNG	Class II	1985-11-01
K854082	Porta-Pole Tm Medical Equipment Pole W/fold	Gray Wave Corp.	FOX	Class I	1985-11-01
K854037	Pulmanex	Life Design Systems, Inc.	BTM	Class II	1985-11-01
K854032	Snap-Lock Additive Cap #Sl 200	Williams Medical Co.	KPE	Class II	1985-11-01
K853812	Photron Neurovisual Stimulator(modification)	Biosan Laboratories, Inc.	HLX	Class II	1985-11-01
K853736	Mentor Brightness Acuity Tester	Mentor O & O, Inc.	HOX	Class I	1985-11-01
K853713	First Temp	Intelligent Medical Systems	FLL	Class II	1985-11-01
K853631	Poly-Sleeve	CooperVision, Inc.			1985-11-01
K853605	Personal Amplifier Slimline III	Electone, Inc.	ESD	Class I	1985-11-01
K853595	Vessa Trekka	Vessa, Ltd.	ITI	Class II	1985-11-01
K853556	Laser Iras	Randwal Instrument Co., Inc.	HPJ	Class II	1985-11-01
K853395	Rms-1000 A.k.a. Raytheon Medical Systems-1000	Raytheon Medical Systems	IZH	Class II	1985-11-01
K853313	Duromedics Cardiac Valve Sizer Set	Hemex Scientific, Inc.	DTI	Class I	1985-11-01
K853259	Mallory/head Total Hip System	Zimmer GmbH	KMC	Class II	1985-11-01
K853044	Stericover	STERIMED, Inc.	IZI	Class II	1985-11-01
K852748	Cordis Models 336A,336b,337a & 334 Cardiac Pacemak	Cordis US Corp.	DXY	Class III	1985-11-01
K852688	Medtronics Models 8320/8322/8329	Medtronic, Inc.	DXY	Class III	1985-11-01
K852456	Fap-Cath	Research Medical, Inc.	DQO	Class II	1985-11-01
K852192	Disposable Steam Biological Test Pack	Parke-Davis Co.	FRC	Class II	1985-11-01
K852115	Ars Enterprises Ethylene Oxide Gas Sterilizer	Ars Enterprises, Inc.	FLF	Class II	1985-11-01
K852097	Percutaneous Greenfield Vena Cava Filter System	Medi-Tech, Inc.	DTK	Class II	1985-11-01
K850691	Antiserum to Human Apolipoprotein a-I	Kent Laboratories, Inc.	MSJ	Class I	1985-11-01
K850690	Antiserum to Human Apolipoprotein B	Kent Laboratories, Inc.	MSJ	Class I	1985-11-01
K850686	Antiserum to Human Prealbumin	Kent Laboratories, Inc.	JZJ	Class I	1985-11-01
K842905	Travenol Multiday Infusor 2C1080	Travenol Laboratories, S.A.	FRN	Class II	1985-11-01
K854228	Columbia 5% Blood Agar	R. Kent Richards, Inc.	KZI	Class I	1985-10-31
K854206	Ultraclone 05-100 Guinea Pig Rbc	Earl-Clay Laboratories, Inc.	KPO	Class II	1985-10-31
K854176	Polychrome IV Stain	Devetec, Inc.	LED	Class I	1985-10-31
K854121	Micro-Mat System	Prevo Micro-Mat System	GKJ	Class I	1985-10-31
K854079	Thrombo Screen Sickle Cell Assay Set	Pacific Hemostasis	GHM	Class II	1985-10-31
K853788	Db Precision Implant System	Driskell Bioengineering	DZE	Class II	1985-10-31
K853769	Irregular Curve Tracing Revisition & Doppler	Hewlett-Packard Co.	DXK	Class II	1985-10-31
K853431	Dental Cement	Dentsply Intl.	EBF	Class II	1985-10-31
K853160	Austenal Modified Acrylic Denture Resin	Austenal Dental, Inc.	ELM	Class II	1985-10-31
K853116	Paxial	Biophysic Medical, Inc.	IYO	Class II	1985-10-31
K853068	Ilex Prompt Clinical Chemistry Analyer	Ilex Corp.	CEM	Class II	1985-10-31
K852975	Interpore 200 Porous Hydroxyapatite	Inrterpore Intl.	DZC	Class I	1985-10-31
K852620	Safe.n.sure	Ashai Co., Ltd.	HIS	Class II	1985-10-31
K852362	Urological Ultrasound Diagnostic Sys/equip. Ssd-52	Johnson & Johnson Professionals, Inc.	IYO	Class II	1985-10-31
K851860	Diasonics Drf-200 Ultrasound Imaging System	Diasonics, Inc.	IYO	Class II	1985-10-31
K851446	Universal Service Module	Diasonics, Inc.	IYO	Class II	1985-10-31
K850834	Sdl-32 Electronic Linear Scanner	Shimadzu Corp.	IYO	Class II	1985-10-31