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 2026-10-29, 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 918 of 3530

510(k) clearances, page 918 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K112720	Mckesson Horizon Cardiology	Change Healthcare Israel Ltd.	LLZ	Class II	2012-01-30
K112600	Angiodynamics, Inc. Venacure Nevertouch Direct Procedure Kit	Boston Scientific Corporation	GEX	Class II	2012-01-30
K112539	Chison Digital Ultrasound System, Convex Probe, Linear Probe, Transvaginal Micro-Convex Probe, Transrectal Linear Probe	Leiker Regulatory & Quality Consulting	IYO	Class II	2012-01-30
K112333	Lrt Attachment	Bcf Certification, Inc.	NHA	Class II	2012-01-30
K112018	Smart Read Eztest Steam	Mesa Laboratories Inc	FRC	Class II	2012-01-30
K111413	Biogel (R) Indicator (R) Underglove	Molnlycke Health Care, US LLC	KGO	Class I	2012-01-30
K111385	Dell Ultrasharp U3011 W/qubyx Perfectlum Bundle	Qubyx Limited	LLZ	Class II	2012-01-30
K111332	Clarity Obp System	Elekta Limited	IYE	Class II	2012-01-30
K113842	Catheter Connections' Dualcap Solo	Catheter Connections, Inc.	QBP	Class II	2012-01-27
K113718	Ncb Straight Narrow Shaft Plates	Zimmer GmbH	HRS	Class II	2012-01-27
K113606	Nnc Gold Abutment for Bridges	Straumann USA, LLC	NHA	Class II	2012-01-27
K113571	Gmk Resufacing Patella Size 4	Medacta International SA	JWH	Class II	2012-01-27
K113524	Validate Vit D Calibration Verification/ Linearity Test Kit	Maine Standards Co.	JJX	Class I	2012-01-27
K113522	Pathassist Light Seeker	Entellus Medical, Inc.	LRC	Class I	2012-01-27
K113486	Volcano S5i Intravascular Ultracound Imaging and Pressure System	Volcano Corporation	IYO	Class II	2012-01-27
K113273	Spotlight Access System	Johnson & Johnson	GZT	Class II	2012-01-27
K113185	Model Hbp-1300	Omron Healthcare Co., Ltd.	DXN	Class II	2012-01-27
K113141	Microlife Dual Mode Thermometer,model Ifr1mj1	Microlife Intellectual Property GmbH	FLL	Class II	2012-01-27
K113049	Socket Graft	Steiner Laboratories	LYC	Class II	2012-01-27
K112879	Rest Assured Ready to Wear Nite Protector	Ranir, LLC	OBR	Unclassified	2012-01-27
K112875	Blue Sky Bio Dental Taper Hex Implant Systems	Blue Sky Bio, LLC	DZE	Class II	2012-01-27
K112804	Fingertip Pulse Oximeter	Guangdong Biolight Meditech Co., Ltd	DQA	Class II	2012-01-27
K112319	Electro-Cap System	Electro-Cap Intl., Inc.	GXY	Class II	2012-01-27
K112233	Bovie J-Plasma Handpiece with Retractable Cutting Blade	Apyx Medical Corporation	GEI	Class II	2012-01-27
K111595	Neumovent Graphnet	Tecme S.A.	CBK	Class II	2012-01-27
K111294	Santorini Spinal System	K2M, Inc	MQP	Class II	2012-01-27
K102383	Microdot & Microdot Xtra	Cambridge Sensors Limited	NBW	Class II	2012-01-27
K120075	Am-6000 Anesthesia Machine	Advanced Instrumentations, Inc.	BSZ	Class II	2012-01-26
K120073	Infx-8000V with	Toshibamedical Systems Corporation	OWB	Class II	2012-01-26
K113644	Pilot Tube Repair Kit	Instrumentation Industries, Incorporated	BSK	Class II	2012-01-26
K113447	Rise Spacer	Globus Medical, Inc.	MAX	Class II	2012-01-26
K113218	Pioneer Release Laminoplasty Plating System	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)	NQW	Class II	2012-01-26
K113208	Gal-1A Blood Glucose Monitoring System	Apex Biotechnology Corp.	CGA	Class II	2012-01-26
K113184	Logicscan 64 Logicscan 128	Telemed	IYN	Class II	2012-01-26
K113030	Spineology Peek Bullet Lumbar Interbody Fusion Device	Spineology, Inc.	MAX	Class II	2012-01-26
K112959	Calg-Str Exercise ECG Analysis Algorithm	Philips Health Care	DPS	Class II	2012-01-26
K112820	Fore-Sight Absolute Tissue Oximeter	Cas Medical Systems, Inc.	MUD	Class II	2012-01-26
K112429	Giza(r) Vertebral Body Replacement	Eden Spine, LLC	MQP	Class II	2012-01-26
K112427	Bicarb Mixing and Distribution System	Isopure Corp	FIN	Class II	2012-01-26
K112045	Simpleline II Abutment System	Dentium Co., Ltd.	NHA	Class II	2012-01-26
K112044	Anaxblend Model 20Xxx (Several), Anaxgum Model 25Xxx (U), Mock-Up Direct Model 240Xxx (U), Mock-Up Direct Flow Model 24A	Anaxdent GmbH	EBF	Class II	2012-01-26
K111986	Logic Laparoscopic Instrument System	Surgical Innovations Ltd	GEI	Class II	2012-01-26
K111786	Hoffmann 3 Modular External Fixation System	Stryker Corp.	KTT	Class II	2012-01-26
K111232	Gap Endo-Exo Medullary System	Orthopediatrics Canada ULC	HSB	Class II	2012-01-26
K111134	Non-Sterile, Powder-Free Nitrile Examination Glove, Blue, Tested for Use with Chemotherapy Drugs	Siem Aempemed Corp., Ltd.	LZA	Class I	2012-01-26
K110312	Clickfine Autoprotect Pen Needle	Ypsomed AG	FMI	Class II	2012-01-26
K110066	Aquilion Prime	Toshiba America Medical Systems, In.C	JAK	Class II	2012-01-26
K102541	Cynosure Cellulaze Laser	Cynosure, LLC	OYW	Class II	2012-01-26
K113855	Panorad, Panorad Sl	Imix Adr Finland Oy	KPR	Class II	2012-01-25
K113845	Tubing, Conmnectors, and Accessories Wit Balance Biosurface	Medtronic, Inc.	DTL	Class II	2012-01-25