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 1929 of 3531

510(k) clearances, page 1929 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K964694	Elecsys Lh Assay	Boehringer Mannheim Corp.	CEP	Class I	1997-01-24
K964680	Comfortaid Hearing Aid	Ethical Hearing Instruments	ESD	Class I	1997-01-24
K964649	Vazquez Diner Intraoral Distraction Device	Howmedica Leibinger, Inc.	JEY	Class II	1997-01-24
K964577	Innova Comfortpulse Vaginal Electrode (199204)/Innova Comfortpulse Small Vaginal Electrode(199205)	Empi	KPI	Class II	1997-01-24
K964537	Bonesource Hydroxyapatite Cement (Hac)	Osteogenics, Inc.	GXP	Class II	1997-01-24
K964531	Profile 70000 Quadrature Volume Neck Coil	Us Asia Instruments, Inc.	LNH	Class II	1997-01-24
K964516	Tap	Medtronic, Inc.	LRK	Class II	1997-01-24
K964484	Kartush Tm Patcher	Xomed, Inc.	KHJ	Class II	1997-01-24
K964482	Flexible Ureteroscope	Applied Fiberoptics, Inc.	FGB	Class II	1997-01-24
K964460	The Robolite	Shai Syg Motion and Innovations, Ltd.	JQP	Class I	1997-01-24
K964423	Axiom Inf	Axiom Manufacturing	IPF	Class II	1997-01-24
K964317	Foxell, Mediguard, Plus Multiple Brand Names	Nantong Ruchang Latex Products Co., Ltd.	LYY	Class I	1997-01-24
K963701	Soma Safe Enclosure	Nova Technology Corp.	FNL	Class II	1997-01-24
K963498	Ferr Flex Reagent Cartridge	Dade Chemistry Systems, Inc.	JMG	Class II	1997-01-24
K963479	Wheelchair Belt	DeRoyal Industries, Inc.	KID	Class I	1997-01-24
K963376	Micro H2	Micro Direct, Inc.	NRH	Class I	1997-01-24
K963331	Medtexx	Regalfield Sdn. Bhd.	LYY	Class I	1997-01-24
K960444	Finn Rod to Rod Connector	Smith & Nephew Richards, Inc.	KWP	Class II	1997-01-24
K964402	Versatrac (Tm) Lumbar Retractor System	V. Mueller Neuro/Spine	GZT	Class II	1997-01-23
K964320	Tony Riso 25/30 Multifunction Scaler	Tony Riso Co., Inc.	ELC	Class II	1997-01-23
K964272	Performr Series Ep Diagnostic Catheters	Medtronic Cardiorhythm	DRF	Class II	1997-01-23
K963935	Olympus Critical Care Monitoring System	Optical Sensors, Inc.	CCC	Class II	1997-01-23
K963851	Tilting Radiographic Table (Remote)	Acoma Medical Imaging, Inc.	IXR	Class II	1997-01-23
K963597	Silent Night I	Local Silence, Inc.	MNR	Class II	1997-01-23
K962492	Silenzio Plus Continuous Positive Airway Pressure System	Nidek Medical Products Inc	BYE	Class II	1997-01-23
K961845	Percupump II with Eda	E-Z-EM, Inc	DSB	Class II	1997-01-23
K950422	First Touch Disposables Temperature Probes	First Touch Disposables, Inc.	FMT	Class II	1997-01-23
K965152	A.c.t. II	Remel Inc	JSM	Class I	1997-01-22
K965151	A.c.t. III	Remel Inc	JSM	Class I	1997-01-22
K965150	A.c.t. IV	Remel Inc	JSM	Class I	1997-01-22
K965149	A.c.t. I	Remel Inc	JSM	Class I	1997-01-22
K964925	Sealite Sciences, Inc. Aqualite Lh	Sealite Sciences, Inc.	CEP	Class I	1997-01-22
K964921	Basic Biopsy Tray. Disposable, Sterile	Trinity Laboratories, Inc.	LRO	Class II	1997-01-22
K964754	Ortho-Mune Okb (Cd19)- Monoclonal Antibody (Murine) Phycoerythrine Conjugate	Ortho Diagnostic Systems, Inc.	GKZ	Class II	1997-01-22
K964619	Delivery System(sds 1400 Xl)/delivery System Cuspidor(sds1450,sds1650 Xl)	Sds Dental, Inc.	EIA	Class I	1997-01-22
K964525	Prime & Bond 2.1 M.p. Dentin/enamel Bonding Agent W/activator	Dentsply Intl.	KLE	Class II	1997-01-22
K964470	Applied Medical Clip Applier	Applied Medical Resources Corp	FZP	Class II	1997-01-22
K964409	Hcl - 200 Biochemistry Analyzer	Hcl Laboratory Systems, Inc.	JJF	Class I	1997-01-22
K964381	Avanta Orthopaedics Trapezial Implant	Avanta Orthopaedics, Inc.	KYI	Class II	1997-01-22
K964380	Lc-250 Infrared Light Coagulator	Nk-Optik America	HQB	Class II	1997-01-22
K964285	Tetric Ceram	Ivoclar North America, Inc.	EBF	Class II	1997-01-22
K964283	Autoprime	Arbor Technologies, Inc.	FPB	Class II	1997-01-22
K964279	Softrans Intrauterine Pressure Catheter System (Iup 4000 Softrans Iupc)	Graphic Controls Corp.	KXO	Class II	1997-01-22
K964248	Heartport Endocoronary Sinus Cathetr	Heartport, Inc.	DWF	Class II	1997-01-22
K964246	Novabed Patient Transfer System	Nova Technology Corp.	FNL	Class II	1997-01-22
K964240	Biafine Wound Dressing Emulsion	Medix Pharmaceuticals Americas, Inc.	MGQ	Unclassified	1997-01-22
K964191	Calcium Hydroxide Medicament	Sybron Dental Specialties, Inc.	EJK	Class II	1997-01-22
K963937	Northwest Precision Technologies 6.5 Mm Cannulated Cannulated Cancellous Screw	Northwest Precision Technologies	HWC	Class II	1997-01-22
K963739	Leibinger - Luhr Small Orthopedic Bone Screws	Howmedica Leibinger, Inc.	HWC	Class II	1997-01-22
K963702	Acs Hi-Torque Iron Man Guide Wire	Advanced Cardiovascular Systems, Inc.	DQX	Class II	1997-01-22