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 2026-10-26, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 730 of 3530

510(k) clearances, page 730 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K142743	AliveCor Heart Monitor	AliveCor	DXH	Class II	2015-01-27
K142625	PANAVIA SA Cement Plus Automix; (Universal(A2), White, Translucent); Value Pack (Universal(A2), Translucent); Automix Trial (Universal(A2), White, Translucent); Mixing tip; Endo tip (SS)	Kuraray Noritake Dental, Inc.	EMA	Class II	2015-01-27
K142249	Schoelly Sinuscope	Schoelly Fiberoptic, GmbH	EOB	Class II	2015-01-27
K141634	Nautilus Delta	Romedex International SRL	LJS	Class II	2015-01-27
K143490	VERTA Corpectomy Cage	Camber Spine	MQP	Class II	2015-01-26
K143163	AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer, AVS® Navigator PEEK Spacer, AVS® ARIA PEEK Spacer, AccuLIF TL and PL Cage, AVS® Anchor-L Spacer, Aero-AL Lumbar Cage System	Stryker Corp.	OVD	Class II	2015-01-26
K143151	Cutimed Sorbact Wound Dressings (Cutimed Sorbact Hydroactive, Cutimed Sorbact Hydroactive B, Cutimed Siltec Sorbact)	BSN Medical	FRO	Unclassified	2015-01-26
K143124	KA01 Chitosan Wound Dressing	Foshan United Medical Technologies Ltd.	KGN	Unclassified	2015-01-26
K143061	Activ Ankle Locking Plating System	Newclip Technics	HRS	Class II	2015-01-26
K143059	TAMTEC-HANA TENS / EMS (Sport Muscle Stimulator)	Tone-a-Matic International, Inc.	NGX	Class II	2015-01-26
K142655	CB PROT II Posterior Spinal System	Chin Bone Technique Corp	MNH	Class II	2015-01-26
K142606	Trident® Tritanium® PST® Acetabular Shells	Mako Surgical Corp.	LPH	Class II	2015-01-26
K142491	ZEL TIQ CoolSculpting System	Zeltiq Aesthetics Inc	OOK	Class II	2015-01-26
K142321	Benchmark Intracranial Access System	Penumbra Inc.	DQY	Class II	2015-01-26
K142284	Clear Care Plus Cleaning & Disinfectiong Solution with Hydraglyde	Alcon Laboratories	LPN	Class II	2015-01-26
K142237	Aviator Anterior Cervical Plate (ACP) System	Stryker Corp.	KWQ	Class II	2015-01-26
K142222	NewTom 5G	Qr S.r.l.	JAK	Class II	2015-01-26
K142201	OMNI Interface Acetabular System	Omnlife Science	LPH	Class II	2015-01-26
K141980	Leva (Tm) Spacer System	Spine Wave Inc	MAX	Class II	2015-01-26
K141685	Croc	Safeguard US Operating LLC	DXC	Class II	2015-01-26
K143751	Visi Mobile Monitoring System	Sotera Wireless	MWI	Class II	2015-01-23
K143639	IMMULITE 2000 CEA Calibration Verification Material	Siemens Healthcare Diagnostics Inc.	JJX	Class I	2015-01-23
K143571	Audit MicroControls Linearity LQ Cystatin-C	Aalto Scientific Ltd.	JJX	Class I	2015-01-23
K143460	Cannulated Screw System	Wrightmedicaltechnologyinc	HWC	Class II	2015-01-23
K143396	omni TRAX Active Patient Tracker	Civco Medical Instruments CO Inc dba Civco Medical Solutions	IYO	Class II	2015-01-23
K143394	Acumed Small Fragment Base Set	Acumed LLC	HRS	Class II	2015-01-23
K143392	Quattro Bolt Tenodesis Screw	Cayenne Medical Inc.	MBI	Class II	2015-01-23
K143159	Cannulated PediGuard Needle#1, Cannulated PediGuard Needle#2, Cannulated PediGuard Needle 120mm, Cannulated PediGuard Handle; PediGuard Tri Tip Ø4.0mm, PediGuard Tri Tip Ø3.2mm, PediGuard Tri Tip Ø2.5mm, PediGuard Ø2.5mm XS, PediGuard Curv, PediGuard Curv XS	Spineguard, Inc.	PDQ	Class II	2015-01-23
K143000	Ris500	Ray Co., Ltd.	MQB	Class II	2015-01-23
K142552	A7 Anesthesia System	Shenzhen Mindray Bio-Medical Electronics Co.,LTD	BSZ	Class II	2015-01-23
K142348	OsteoSeal Bone Hemostat	Hemostasis, LLC	MTJ	Unclassified	2015-01-23
K142207	TransferMan 4m Micromanipulator	Eppendorf AG	MQJ	Class II	2015-01-23
K142030	Stgc-Lordotic	Cardinal Spine, LLC	MQP	Class II	2015-01-23
K141830	Stimulan Kit, Stimulan Rapid Cure	Biocomposites, Ltd.	MQV	Class II	2015-01-23
K141722	Carefusion Gold Tissue Marker	Care Fusion	NEU	Class II	2015-01-23
K141511	Sidelaze800 Laser Beam Delivery Accessory for Cynosure 1440Mm Wavelength Lasers	Cynosure, LLC	GEX	Class II	2015-01-23
K141448	Tevadaptor Closed Drug Reconstitution and Transfer System	Teva Medical Ltd., Migada Plant	ONB	Class II	2015-01-23
K141142	Mammaprint Ffpe	Agendia Inc	NYI	Class II	2015-01-23
K140932	Amsel Occluder Device	Amsel Medical Corporation	FZP	Class II	2015-01-23
K140265	Electrode for Urinary Incontinence	Guangzhou Finecure Medical Equipment Co.,Ltd	KPI	Class II	2015-01-23
K133729	Wound Dressing with Manuka Honey	Manuka Health New Zealand, Ltd.	FRO	Unclassified	2015-01-23
K133659	Heartstart Xl+defibrillator/monitor with End-Tidal Carbon Dioxide Monitoring	Philips North America LLC	MKJ	Class III	2015-01-23
DEN140038	Dexcom Share Direct Secondary Displays	Dexcom, Inc.	PJT	Class II	2015-01-23
K143718	Mammography Color Display DP-M3010	Canon, Inc.	PGY	Class II	2015-01-22
K143247	Powder Free Nitrile Examination Gloves, Nonsterile,(Blue,Black, and White Colored)	Central Medicare Sdn Bhd	LZA	Class I	2015-01-22
K142945	Sonoma Fibula Repair System	Sonoma Orthopedic Products, Inc.	HSB	Class II	2015-01-22
K142932	Deltex Medical KDP72 Doppler Probe	Deltex Medical Limited	DPT	Class II	2015-01-22
K142773	EOS System	EOS imaging	KPR	Class II	2015-01-22
K140547	Excera Fitrite Total Hip Arthroplasty System	Excera Orthopedics, Inc.	LPH	Class II	2015-01-22
K133985	Digital Electrocardiograph	Shenzhen Biocare Bio-Medical Equipment Co., Ltd.	DPS	Class II	2015-01-22