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 888 of 3530

510(k) clearances, page 888 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K121832	Resolve Biliary Locking Drainage Catheter	Merit Medical Systems, Inc.	FGE	Class II	2012-07-17
K121531	A&j 5L Poca Series Oxygen Concentrator	Zhongshan A&j Medical Equipment Co., Ltd.	CAW	Class II	2012-07-17
K121428	Non-Contact Clinical Thermometer	Radiant Innovation Inc.	FLL	Class II	2012-07-17
K121253	Meridian Cranial Perforator	Adeor Medical Technologies GmbH	HBF	Class II	2012-07-17
K120562	Performax Pediatric Ee Total Face Mask	Respironics, Inc.	BZD	Class II	2012-07-17
K113311	Tio2mesh Tm	Biocer Entwicklungs-GmbH	FTL	Class II	2012-07-17
K112101	Fastep Hcg Pregancy Serum/urine Cassette and Dipstick Tests	Polymed Therapeutics, Inc.	JHI	Class II	2012-07-17
K111353	Accu-Check Combo System	Roche Diagnostics GmbH	LZG	Class II	2012-07-17
K121837	Nuvasive Brigade Anterior Plate System	NuVasive Inc	KWQ	Class II	2012-07-16
K121833	Ostomy Irrigation Set	MEDLINE INDUSTRIES, LP - Northfield	EXD	Class II	2012-07-16
K121600	Echelon 60 Endoscpic Linear Cutter Reload, White	Ethicon Endo-Surgery Inc	GDW	Class II	2012-07-16
K121474	Disposable Linear Stapler, Disposable Linear Cutter	Changzhou Kangdi Medical Stapler Co., Ltd.	GDW	Class II	2012-07-16
K121160	Magnetom Spectra	Siemens Medical Solutions USA, Inc.	LNH	Class II	2012-07-16
K120920	Hsiner CPAP Silicone Nasal Mask Size Xs/petite Hsiner Nasal Pillow Mask Hsiner Infant CPAP Cannula	Hsiner Co., Ltd.	BZD	Class II	2012-07-16
K120564	Calypso System	Hogan Lovells US LLP	NKB	Class II	2012-07-16
K120253	Elcam Vital Signs Wireless System (Vsws)	Elcam Medical A.C.A.L.	DRG	Class II	2012-07-16
K113562	3Mp Color Lcd Monitor, Radiforce Rx340	Eizo Nanao Corporation	LLZ	Class II	2012-07-16
K113446	Vignet Telehealth Manager	Vignet, Inc.	DRG	Class II	2012-07-16
K113335	Heartrail III Guiding Catheter	Terumo Corp.	DQO	Class II	2012-07-16
K113306	Cardio 7	Bionet Co., Ltd.	DPS	Class II	2012-07-16
K121767	Cardioblate Gemini Surgical Ablation Device	Medtronic, Inc.	OCL	Class II	2012-07-13
K121745	Mantaray Guidewires	Boston Scientific Corporation	DQX	Class II	2012-07-13
K121733	Infill Intervertebral Body Fusion Device	Pinnacle Spine Group, LLC	MAX	Class II	2012-07-13
K121170	Resin 11	Respinnovation SAS	BYI	Class II	2012-07-13
K121161	Empty Eva Solution Container Empty Eva Dual Chamber Solution Container	Acta Medical L.L.C.	KPE	Class II	2012-07-13
K121017	Capnography Pad (92516)	GE Healthcare	CCK	Class II	2012-07-13
K120903	Congruent Bone Plate System: Acu-Loc 2 Plate	Acumed LLC	HRS	Class II	2012-07-13
K120827	Quill Pdo Knotless Tissue-Closure Device (Polydixanone)	Angiotech	NEW	Class II	2012-07-13
K120481	Lil-Lets Silk Comfort Compact, Plastic Applicator, Lite, Regular, Super, Super Plus and Ultra Lil-Lets Non Applicator,	TOSAMA d.o.o.	HEB	Class II	2012-07-13
K120413	Simplexa Flu A/b & Rsv Direct, Simplexa Flu A/b & Rsv Positive Control Pack	DiaSorin Molecular LLC	OCC	Class II	2012-07-13
K120402	Crux Vena Cava Filter System	Crux Biomedical	DTK	Class II	2012-07-13
K113574	Flexitime Monophase Pro Scan	Kulzer GmbH	ELW	Class II	2012-07-13
K113513	Plancet	Micropoint Technologies Pte, Ltd.	FMK	Class II	2012-07-13
K113374	Ace Albumin Reagent Ace Total Protein Reagent Ace Calcium-Arsenazo Reagent Ace Phosphorus u.v. Reagent	Alfa Wassermann Diagnostic Technologies, Inc.	CIX	Class II	2012-07-13
K113192	Healthpro Blood Glucose Monitoring System	Infopia Co, Ltd.	NBW	Class II	2012-07-13
K112840	Capnodura Combi & Capnodura Pedi CO2 Detector	Seebreath AB	CCK	Class II	2012-07-13
K112413	Ri Msc (Migration Sedimentation Chamber)	Research Instruments Ltd	MQK	Class II	2012-07-13
K112390	Monica An24	Monica Healthcare	OSP	Class II	2012-07-13
K111014	Lsi Solutions Fornisee System Uterine Manipulator and Accessories	Lsi Solutions Inc.	HEW	Class II	2012-07-13
K121529	Black Nitrile Powder-Free Examination Gloves	Northstar Healthcare Holdings	LZA	Class I	2012-07-12
K121347	Presson Electrode	Rhythmlink International, LLC	GXZ	Class II	2012-07-12
K121306	Smartstitch M-Connector Ultra Smartstitch Suture Device Handle Smartstitch Suture Device Handle	Arthocare Corporation	GAT	Class II	2012-07-12
K121198	Bw685, Bw685s	Biegler GmbH	LGZ	Class II	2012-07-12
K121113	Biopsy Sciences, Inc. Hydromark Brest Biosy Site Marker	Biopsy Sciences, LLC	NEU	Class II	2012-07-12
K120836	0.9% Sodium Chloride Flish Syringe	Am USA	NGT	Class II	2012-07-12
K120812	Renaissance	Mazor Robotics Ltd	HAW	Class II	2012-07-12
K113620	Myrian 1.11	Intrasense	LLZ	Class II	2012-07-12
K113436	Ace Alkaline Phosphatase Reagent, Ace Amylase Reagent, Ace Ldh-L Reagent	Alfa Wassermann	CJE	Class II	2012-07-12
K112193	Arrow Reverse Shoulder System	Fournitures Hospitalieres Industrie	PHX	Class II	2012-07-12
K110558	Cs1000 Light Therapy Device	Genesis Health Light Corporation	ILY	Class II	2012-07-12