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 677 of 3530

510(k) clearances, page 677 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K152513	8X-10-XXXX Camera System	Santa Barbara Imaging Systems	GCJ	Class II	2015-12-15
K152267	Remedy® Shoulder Spacer	Osteoremedies, LLC	KWS	Class II	2015-12-15
K151496	Latitude-C Cervical Interbody Spacer System	Degen Medical	ODP	Class II	2015-12-15
K151063	Monitor B40	GE Medical Systems China Co., Ltd.	MHX	Class II	2015-12-15
K153122	Endoskeleton(r) TCS System	Titan Spine, LLC	OVE	Class II	2015-12-14
K152767	Otc12d Auto Radiographic System	Del Medical, Inc.	KPR	Class II	2015-12-14
K152554	Site-Rite 8 Ultrasound System, Site-Rite 8 Ultrasound System with Pinpoint GT Technology	C.R. Bard Inc	IYO	Class II	2015-12-14
K152341	ViSi Mobile Monitoring System	Sotera Wireless	MWI	Class II	2015-12-14
K152202	Intermediate Catheter, 105 cm, Intermediate Catheter, 115cm, Intermediate Catheter , 125cm	Tni Manufacturing, Inc.	DQY	Class II	2015-12-14
K152172	Econsole1	DRTECH Corporation	LLZ	Class II	2015-12-14
K151926	QuickRay HD Intraoral Sensor	Denterprise International, Inc.	MUH	Class II	2015-12-14
K151611	OneTouch Ultra Plus Flex Blood Glucose Monitoring System	Lifescan Europe GmbH	NBW	Class II	2015-12-14
K150854	ImmunoCAP Specific IgE; ImmunoCAP Allergen f439, Hazelnut; ImmunoCAP Allergen f440, Hazelnut; ImmunoCAP Allergen f441, Walnut; ImmunoCAP Allergen f442, Walnut; ImmunoCAP Allergen f443, Cashew nut	Phadia AB	DHB	Class II	2015-12-14
K150782	AbStats Gateway	Gi Logic, Inc.	DQD	Class II	2015-12-14
K150769	Cardinal Health Trochanteric IM Nail System	Cardinalhealth	HSB	Class II	2015-12-14
K150408	V-Steady, V-Fast	G21, S.r.l.	LOD	Class II	2015-12-14
K150877	Acl Top Family 50 Series: Acl Top 350 Cts; Acl Top 550 Cts; Acl Top 750; Acl Top 750 Cts; Acl Top 750 Las	Instrumentation Laboratory Co.	GKP	Class II	2015-12-13
K153461	Guide wire for Edi Catheter 6 Fr, Guide wire for Edi Catheter 8 Fr, 100 cm, Guide wire for Edi Catheter 8 Fr, 125 cm	Maquet Critical Care AB	KNT	Class II	2015-12-11
K153313	SpeedLock Knotless Fixation System	ArthroCare Corporation	MBI	Class II	2015-12-11
K153257	BD FlowSmart Set, MiniMed Pro-Set	Becton Dickinson & Co	FPA	Class II	2015-12-11
K153088	AXIOS Stent with Delivery System, AXIOS Stent with Electro-cautery Enhanced Delivery System	Boston Scientific Corporation	PCU	Class II	2015-12-11
K153011	iViewDose R1.0	Elekta Limited	IYE	Class II	2015-12-11
K152987	Xenco Medical Cervical Interbody System, Xenco Medical Lumbar Interbody System	Xenco Medical LLC	ODP	Class II	2015-12-11
K152974	ORTHOLOC® 3Di Foot Plating Reconstruction System	Wrightmedicaltechnologyinc	HRS	Class II	2015-12-11
K152639	Dr 600	AGFA Healthcare Corp.	MQB	Class II	2015-12-11
K152609	GORE SYNECOR Biomaterial	W. L. Gore & Associates, Inc.	FTL	Class II	2015-12-11
K152451	VINTAGE Art LF	Shofu Dental Corp.	EIH	Class II	2015-12-11
K152306	MotoBand¿ CP Implant System	Crossroads Extremity Systems LLC	HRS	Class II	2015-12-11
K152157	LC Bead LUMI	BIOCOMPATIBLES U.K. Limited, a BTG Company	KRD	Class II	2015-12-11
K152153	MicroSpot Handpiece	Asclepion Laser Technologies GmbH	GEX	Class II	2015-12-11
K151900	VariLift-L Interbody Fusion Device	Wenzel Spine	MAX	Class II	2015-12-11
K151767	Trinidad CH system, TD-LYTE Integrated Multisensor (Na, K, CI), TD-LYTE IMT Standard A, TD-LYTE IMT Standard B + Salt Bridge, Trinidad CH Albumin BCP reagent (Alb_P), Trinidad CH Albumin BCP Calibrator	Siemens Healthcare Diagnostics Inc.	JGS	Class II	2015-12-11
K151381	Mallinckrodt Oral/Nasal Tracheal Tube Cuffless, Non-DEHP, Murphy Eye	Medtronic, Inc.	BTR	Class II	2015-12-11
K151114	Medismart ( Latex Surgeon¿s Gloves powdered ) and Medismart + (Latex Surgeon¿s Gloves Powder Free, Polymer coated with protein	St. Marys Rubbers Pvt, Ltd.	KGO	Class I	2015-12-11
K150300	Liquichek Cardiac Markers Plus Control LT	Bio-Rad Laboratories Inc.	JJY	Class I	2015-12-11
K143514	Panther StereoSeed	Prowess, Inc.	MUJ	Class II	2015-12-11
K143222	FIREFLY Pedicle Screw Navigation Guide	Mighty Oak Medical	MNI	Class II	2015-12-11
K143013	Spinal Inner Fixation System	Changzhou Dingjian Medical Appliance Co., Ltd.	MNH	Class II	2015-12-11
K153298	AccuCath Intravascular Catheter	C.R. Bard Inc	FOZ	Class II	2015-12-10
K152732	AOS Small Fragment Plating System	Avanced Orthopaedic Solutions, Inc. (Aos)	HRS	Class II	2015-12-10
K152355	Twin Peaks Lumbar Interbody Fusion System	Spineway	MAX	Class II	2015-12-10
K152326	Biomet Microfixation OmniMax MMF System	Biomet Microfixation	JEY	Class II	2015-12-10
K152182	Fuse Gastroscopy System	Boston Scientific Corporation	FDS	Class II	2015-12-10
K152001	Sterile Repositionable Hemostasis Clipping Device	Micro-Tech (Nanjing) Co., Ltd.	PKL	Class II	2015-12-10
K151933	BRX PRO Bruxism Guard	12th Man Technologies, Inc.	MQC	Unclassified	2015-12-10
K151699	BEAUTIFIL II Enamel	Shofu Dental Corp.	EBF	Class II	2015-12-10
K151158	ALP VasQcare Take Home System	Currie Medical Specialties, Inc.	JOW	Class II	2015-12-10
K150869	Checkme Pro Health Monitor	Viatom Technology Co., Ltd.	MWI	Class II	2015-12-10
K150708	2008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, 2008T Hemodialysis Machine	Fresenius Medical Care Renal Therapies Group, LLC	KDI	Class II	2015-12-10
K150354	PAPAYA 3D Plus	Genoray Co., Ltd.	OAS	Class II	2015-12-10