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 2026-10-15, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,969 of the 176,366 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	2,569

176,366 records, page 383 of 3528

510(k) clearances, page 383 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K202760	Iridex 810 Laser	Iridex Corporation	HQF	Class II	2020-10-21
K202472	ACTIS Duofix Hip Prosthesis	Depuy Orthopaedics Inc.	LPH	Class II	2020-10-21
K202044	Powerpress Recovery Unit	Hanuri Distribution, Inc	IRP	Class II	2020-10-21
K202030	OASIS MRI System	FUJIFILM Healthcare Americas Corporation	LNH	Class II	2020-10-21
K201884	ReNew XR Handpiece, ReNew XR Handpiece 34cm, ReNew XR Handpiece 42cm, ReNew XR Handpiece 25cm, Ratcheted ReNew XR Handpiece 34cm	Microline Surgical, Inc	GEI	Class II	2020-10-21
K201724	Pentacam AXL Wave	Oculus Optikgerate GmbH	MXK	Class II	2020-10-21
K201688	S.I.N. Instrument Kits	S.I.N. Implant System Ltda	KCT	Class II	2020-10-21
K201670	YSIO X.pree	Siemens Medical Solutions USA, Inc.	KPR	Class II	2020-10-21
K201610	IonicRF Generator	Abbott Medical	GXD	Class II	2020-10-21
K201438	ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis Analyzer	Arlington Scientific, Inc. (Asi)	GMQ	Class II	2020-10-21
K201427	Trivergent Spinal Fixation System	Benvenue Medical, Inc.	NKB	Class II	2020-10-21
K201415	Vial2Bag Advanced 20mm Admixture Device	West Pharmaceutical Services AZ, Inc.	LHI	Class II	2020-10-21
K201268	Ethos Aquell (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water)	Plexus Optix, Inc.	LPL	Class II	2020-10-21
K201155	PleurX Peritoneal Catheter System	Care Fusion	PNG	Class II	2020-10-21
K200507	PRO-DENSE LoVisc Bone Graft Substitute	Wrightmedicaltechnologyinc	MQV	Class II	2020-10-21
K193552	InnovaMatrix	Triad Life Sciences, Inc.	KGN	Unclassified	2020-10-21
K192771	C4 Fiducial Marker	C4 Imaging LLC	NEU	Class II	2020-10-21
K202756	Clariti 1 Day (somofilcon A), Clariti 1 Day Toric (somofilcon A), Clariti 1 Day Multifocal (somofilcon A), Clariti 1 Day Multifocal Toric (somofilcon A)	CooperVision, Inc.	LPL	Class II	2020-10-20
K202393	SpineJack Expansion Kit	Stryker Corp.	NDN	Class II	2020-10-20
K201139	WEGO-PDO Barbed Suture	Foosin Medical Supplies Inc., Ltd.	NEW	Class II	2020-10-20
K200794	AccelFix Spinal Fixation System	L&K Biomed Co.,Ltd.	NKB	Class II	2020-10-20
K193000	Hexanium® ACIF	Spinevision SAS	OVE	Class II	2020-10-20
K181477	MS Lide Implant Systems	Hangzhou Minsheng Lide Medical Science & Technology Co., Ltd.	DZE	Class II	2020-10-20
K202771	CD Horizon Spinal System	Medtronic, Inc.	NKB	Class II	2020-10-19
K202374	4MP/8MP Color LCD Monitors C44W+/C82W+, C83W+, C85W+	Shenzhen Beacon Display Technology Co., Ltd.	PGY	Class II	2020-10-19
K202100	Neocis Guidance System (NGS) with Clamped Chairside Patient Splint (C-CPS)	Neocis Inc.	PLV	Class II	2020-10-19
K201771	Single Use Rotatable and Repositionable Hemoclip	Anrei Medical (HangZhou) CO., Ltd.	PKL	Class II	2020-10-19
K201572	TAPESTRY Biointegrative Implant	Embody, Inc.	OWY	Class II	2020-10-19
K200821	anti-bacterial bandage	Planet (Suzhou) Medical Products Co., Ltd.	FRO	Unclassified	2020-10-19
K200237	Transcutaneous Electronic Nerve Stimulator	Shenzhen Kentro Medical Electronics Co., Ltd	NUH	Class II	2020-10-19
K200084	Zavation IBF System	Zavation Medical Products, LLC	MAX	Class II	2020-10-19
K202737	Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Xario200G and Xario100G, Diagnostic Ultrasound System	Canon Medical Systems Corporation	IYN	Class II	2020-10-16
K202733	Quantum Ventilation Module	Spectrum Medical Inc	DTX	Class II	2020-10-16
K202193	PULLUP BTB Adjustable Fixation System for Ligament Reconstruction, PULLUP CLIP Adjustable Fixation System for Ligament Reconstruction, PULLUP TEX CLIP Adjustable Fixation System for Ligament Reconstruction, BT LOOP Adjustable Fixation System for Ligament Reconstruction	S.B.M. SAS (Science & Bio Materials)	MBI	Class II	2020-10-16
K202016	Dall-Miles® Cable System	Howmedica Osteonics Corp., dba Stryker Orthopaedics	JDQ	Class II	2020-10-16
K202010	Disposable Vinyl Glove	Better Health Medical Products Co., Ltd.	LYZ	Class I	2020-10-16
K201816	Arthrotap	Accuro Technologies, Inc.	FMF	Class II	2020-10-16
K201803	OSSIOfiber™ Hammertoe Fixation System/OSSIOfiber™ Hammertoe Fixation Implant	OSSIO, Ltd.	HTY	Class II	2020-10-16
K201710	A View LCS	Coreline Soft Co., Ltd.	LLZ	Class II	2020-10-16
K201535	Cerament Bone Void Filler	Bonesupport Inc	MQV	Class II	2020-10-16
K201396	Finetest Lite Smart Blood Glucose Monitoring System	OSANG Healthcare CO., Ltd.	NBW	Class II	2020-10-16
K201129	Medline Smoke Evacuation Pencil	Medline Industires, Inc.	GEI	Class II	2020-10-16
K200906	MINICONE Implant	Medentika GmbH	DZE	Class II	2020-10-16
K200595	CellaVision DC-1, CellaVision DC-1 PPA	Cellavision AB	JOY	Class II	2020-10-16
K200408	VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, VitaVitro® Flushing Buffer Medium	Shenzhen VitaVitro Biotech Co.,Ltd.	MQL	Class II	2020-10-16
K200045	MUTARS Cemented Femoral Stems	implantcast GmbH	MEH	Class II	2020-10-16
K193474	Selectra 3D Outer Guiding Catheters	BIOTRONIK AG	DQY	Class II	2020-10-16
K202683	ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic Ultrasound System, ACUSON Freestyle Diagnostic Ultrasound System,ACUSON S1000, S2000, S3000 Diagnostic Ultrasound Systems, ACUSON P200 Diagnostic Ultrasound System, ACUSON P500 Diagnostic Ultrasound System, ACUSON NX3, NX3 Elite Diagnostic Ultrasound System	Siemens Medical Solutions USA, Inc.	IYN	Class II	2020-10-15
K202680	OsteoMed ExtremiFix Mini & Small Cannulated Screw System	Osteomed	HWC	Class II	2020-10-15
K202665	Echelon Flex 45mm Powered Plus Articulating Endoscopic Linear cutters, Echelon Flex 60mm Powered Plus Articulating Endoscopic Linear cutters, Echelon Endopath Endoscopic Linear Cutter Reloads, 45mm, Echelon Endopath Endoscopic Linear Cutter Reloads, 60mm	Ethicon Endo-Surgery Inc	GDW	Class II	2020-10-15