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 1956 of 3531

510(k) clearances, page 1956 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K960418	Eagle Patient Monitor	Marquette Electronics, Inc.	DSI	Class II	1996-10-02
K960272	Eagle 3000/3100 Patient Monitor	Marquette Electronics, Inc.	MLD	Class II	1996-10-02
K960188	Pressureguard: Selectcare	Span-America Medical Systems, Inc.	FNM	Class II	1996-10-02
K955827	Daneshvar Wound Support Unit	Y. Daneshvar	DXC	Class II	1996-10-02
K953983	Evap-Electrodes Types 8423, 8427, 8410 & 8413 Electrosurgical Vaporization of Soft Tissue	Richard Wolf Medical Instruments Corp.	FAS	Class II	1996-10-02
K944036	Sterimaster Autoclave	Scican Ltd.	FLE	Class II	1996-10-02
K963585	Bladder Manager Pci 5000, Bladderscan Bvi 5000	Diagnostic Ultrasound Corp.	IYO	Class II	1996-10-01
K963243	Heelbo Blazer Sleeved Jacket	Heelbo, Inc.	FMQ	Class I	1996-10-01
K963155	Intermoore Fracture Hip Stem (Modify)	Intermedics Orthopedics	LWJ	Class II	1996-10-01
K963077	Tbd	Acu Med, Inc.	HSB	Class II	1996-10-01
K963058	Infant Warmer System	GE Healthcare	FMT	Class II	1996-10-01
K963040	Manual Phenylalanine Test	Bio-Rad	JNB	Class II	1996-10-01
K963028	Tibial Insert	Encore Orthopedics, Inc.	JWH	Class II	1996-10-01
K962957	Rurasoft 2 Freshlook Colors; Durasoft 2 Freshlook Litetint	Wesley Jessen Corp.	LPL	Class II	1996-10-01
K962923	Depuy Graded Porosity Aml Hip (1371-03/06-500/1371-43/46-500)	Depuy, Inc.	LPH	Class II	1996-10-01
K962823	Synthes Sterile 3.0 Mm Cannulated Screw and Threaded Washer	Synthes (USA) Products LLC	HWC	Class II	1996-10-01
K962804	Acuvue (Etafilcon a) Contact Lens Clear & W/visibility Tint W/uv Blocker	Vistakon, Johnson & Johnson Vision Products, Inc.	LPL	Class II	1996-10-01
K962793	Mitek Micro Anchor	Mitek Products	JDR	Class II	1996-10-01
K962721	Evidence Pregnancy Test	Saliva Diagnostic Systems, Inc.	LCX	Class II	1996-10-01
K962705	Mli Modular Staple	Medicinelodge, Inc.	JDR	Class II	1996-10-01
K962695	Port-a-Cath II Venous Implantable Access Systems Preconnected with Polyurethane Catheter	Sims Deltec, Inc.	LJT	Class II	1996-10-01
K962622	Intra-Oral Thermoplastic Shield	Medtec LLC	KPY	Class I	1996-10-01
K962000	Flexlens(methafilcon a)	Flexlens, Inc.	LPL	Class II	1996-10-01
K961943	Flexlens	Flexlens, Inc.	LPL	Class II	1996-10-01
K961304	Aura Hip System Cemented Femoral Stem/cemented Long Femoral Stem	Exactech, Inc.	JDI	Class II	1996-10-01
K961299	Precision UV (Vasurfilcon a)	Pilkington Barnes-Hind, Ltd.	LPL	Class II	1996-10-01
K961107	B. Braun Guidewires	B.Braun Medical, Inc.	DQX	Class II	1996-10-01
K960633	Press-Fit Flared Shell	Encore Orthopedics, Inc.	LWJ	Class II	1996-10-01
K955846	Model 2082 Temp Plus III Thermometer/model 2087 Temp Plus III Wall Mount Thermometer	Y	FLL	Class II	1996-10-01
K955807	Cotrel-Dubousset (Cd) Spinal	Sofamor Danek USA,Inc.	KWP	Class II	1996-10-01
K963534	Sigma Diagnostics Creatinine Reagent Kit	Sigma Diagnostics, Inc.	CGX	Class II	1996-09-30
K963299	Hwa-to Acupuncture Needles	Lhasa Medical, Inc.	MQX	Class II	1996-09-30
K963291	Varelisa Ana (4) Profile	Elias U.S.A., Inc.	LJM	Class II	1996-09-30
K962867	Sensititre 18 Hour Susceptibility Plates	Sensititre Alamar	JWY	Class II	1996-09-30
K962858	Heartport Endovascular Cardiopulmonary Bypass System Antegrade Sytem (Catalog Number Ecpb-a) Antegrade/retrograde System	Heartport, Inc.	DXC	Class II	1996-09-30
K962751	Ideas' Dual Port	Ideas for Medicine, Inc.	LJT	Class II	1996-09-30
K962747	Pulpdent Endodontic Post Cement Kit	Pulpdent Corporation	EMA	Class II	1996-09-30
K962680	Hyunjae Dental Impression Materials	Hyunjae Corp.	ELW	Class II	1996-09-30
K962651	S-52 Electronic Video Laparoscope	Del Medical Systems Corp.	GCJ	Class II	1996-09-30
K962360	Ifa Kit for the Detection of C-Anca Antibodies	Scimedx Corp.	MOB	Class II	1996-09-30
K962090	Karl Storz Model 203210 O1 Unimat Plus	Karl Storz Endoscopy-America, Inc.	HET	Class II	1996-09-30
K960301	Nd Vision-220 Adaptive Image Processessor	Del Medical Systems Corp.	GCJ	Class II	1996-09-30
K960055	Medtronic Ps Medical Bioglide Vascular Catheter, Sngl Lumen Model Nos 8960 & 8932	Pudenz-Schulte Medical Research Corp.	LJS	Class II	1996-09-30
K953930	Virtuoso Smart CPAP System	Respironics, Inc.	BZD	Class II	1996-09-30
K923880	Orlau Swivel Walker	Mopac, Ltd.	MRI	Class I	1996-09-30
K963604	Dynamic Eq II - 2 Channel Wide Dynamic Range Compression	Midwest City Hearing Aid Center	ESD	Class I	1996-09-27
K963542	Sigma Diagostic Electrolyte Reference Reagent	Sigma Diagnostics, Inc.	JGS	Class II	1996-09-27
K963540	Sigma Diagnostics Electrolyte Buffer	Sigma Diagnostics, Inc.	JFL	Class II	1996-09-27
K963519	Euroline a-675 Seris	Starkey Laboratories, Inc.	ESD	Class I	1996-09-27
K963261	Ebi Thermal Therapy System	Electro-Biology, Inc.	ILO	Class II	1996-09-27