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 2026-11-05, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,132 of the 176,529 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	2,732

176,529 records, page 1388 of 3531

510(k) clearances, page 1388 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K041234	Hemocue Hemoglobin 201Dm Analyzing System	HemoCue AB	GKR	Class II	2004-06-10
K041130	Cds Hematology Calibrator (Cds Cal)	Clinical Diagnostic Solutions, Inc.	KRZ	Class II	2004-06-10
K040941	CPAP Humidifier, Model Hc234 (and Related Accessories)	Fisher & Paykel Healthcare, Inc.	BZD	Class II	2004-06-10
K040926	Ultrasound Scanner, Hudson Models 8000 and 9000	Hudson Diagnostic Imaging, LLC	IYN	Class II	2004-06-10
K040882	Vidas D-Dimer Exclusion Assay, Model 30 442	bioMerieux, Inc.	DAP	Class II	2004-06-10
K040836	Disposable Overtube	United States Endoscopy Group, Inc.	FED	Class II	2004-06-10
K040794	Incubator Cape	Wrapped in Comfort	MMP	Class II	2004-06-10
K040753	R-Test Evolution 3	Novacor	MLO	Class II	2004-06-10
K040723	Microlife Electronic Peak Flow Monitor, with Pef and Fev1, Models Pf-100 and Pf-100-1 (with Software)	Microlife Intellectual Property GmbH	BZH	Class II	2004-06-10
K040697	21.3-Inch (54Cm) Color Lcd Monitor Ccl212 (Cdl2107a)	Totoku Electric Co., Ltd.	LLZ	Class II	2004-06-10
K040689	Eye Sphere Implants	Oculo Plastik, Inc.	HPZ	Class II	2004-06-10
K040675	Axiom Artis U	Siemens Medical Solutions USA, Inc.	OWB	Class II	2004-06-10
K040657	Boussignac/vygon Endotracheal Tube, Model 6501.25/30/35 and 6502.70/75/80	Vygon SA	BTR	Class II	2004-06-10
K033552	Jax-Tcp	Smith & Nephew, Inc.	MQV	Class II	2004-06-10
K033477	Hydrophilic-Antibacterial Intermittent Catheter, Intermittent Catheter Closed System Kit	Rochester Medical Corp.	MJC	Class II	2004-06-10
K032412	Re-Useable Microstaar Injector, Msi-S	Staar Surgical AG	KYB	Class I	2004-06-10
K041444	Bio-Rad D-10 Dual Program	Bio-Rad Laboratories Inc.	LCP	Class II	2004-06-09
K041397	Eg-3830Ut	Pentax Precision Instrument Corp.	ITX	Class II	2004-06-09
K041396	Fg-36Ux Fiber Ultrasound Gastroscope	Pentax Precision Instrument Corp.	ITX	Class II	2004-06-09
K041395	Eg-3630Ur	Pentax Precision Instrument Corp.	ITX	Class II	2004-06-09
K041212	Houva 3 Phototherapy System	National Biological Corp.	FTC	Class II	2004-06-09
K041156	Avant Digital Pulse Oximetry System, Models 4000, 4001	Nonin Medical, Inc	DQA	Class II	2004-06-09
K041035	Hoffrichter Trend 110 CPAP Device with Aquatrend III CPAP Humidifier Accessory for Trend	Hoffrichter GmbH	BZD	Class II	2004-06-09
K040807	Mis Dental Implant System	Mis - Implant Technologies, Ltd.	DZE	Class II	2004-06-09
K040661	Radent Prophy Paste	Pascal International, Inc.	EJR	Class I	2004-06-09
K040484	Maxo2+, Model a and Ae	Maxtec, LLC	CCL	Class II	2004-06-09
K040220	Medical Air Compressor	Event Medical Ltd	BTI	Class II	2004-06-09
K033884	Randox Amikacin	Randox Laboratories, Limited	KLQ	Class II	2004-06-09
K041404	Clearblue Easy Easy Read Pregnancy Test	Unipath, Ltd.	LCX	Class II	2004-06-08
K041380	Imagechecker-CT Software Package with Filling Defect Indicator	R2 Technology, Inc.	OEB	Class II	2004-06-08
K041366	Ipacs Ortho	Realtimeimage, Inc.	LLZ	Class II	2004-06-08
K041146	Control Solutions, Inc., Model Cs3102 Hvg	Control Solutions, Inc.	IPF	Class II	2004-06-08
K041041	Non Sterile Synthetic Powder Free (Yellow) Vinyl Patient Examination Gloves	Shanghai Foremost Plastic Industrial Co., Ltd.	LYZ	Class I	2004-06-08
K040969	Poise Dataengine	Poise Technology Corporation	MWI	Class II	2004-06-08
K040845	Vitek 2 Esbl Test	bioMerieux, Inc.	LON	Class II	2004-06-08
K040813	Nichols Advantage Chemiluminescence Intact Parathyroid Hormone, Model 62-7022	Nichols Institute Diagnostics	CEW	Class II	2004-06-08
K040746	Mra-Cms	Medis Medical Imaging Systems, B.V.	LLZ	Class II	2004-06-08
K040171	Microderm, Model/version 3.5	Visiomed AG	PSN	Class II	2004-06-08
K041385	Modification to Computed Oral Radiology System	Schick Technologies, Inc.	EAP	Class II	2004-06-07
K041319	Sequoia Diagnostic Ultrasound System	Siemens Medical Solutions USA, Inc.	IYN	Class II	2004-06-07
K041281	Datascope 7.5Fr. Iab Catheter and Accessories	Datascope Corp.	DSP	Class II	2004-06-07
K041261	Femoral Hook	Arthrotek, Inc.	MBI	Class II	2004-06-07
K041216	Smith & Nephew Ultrabraid Suture	Smith & Nephew, Inc.	GAT	Class II	2004-06-07
K041214	Pasco Mic and Mic/id Panels	Pasco Laboratories, Inc.	JWY	Class II	2004-06-07
K041180	Quantix or Vessel Stabilizer Device	Cardiosonix, Ltd.	DPW	Class II	2004-06-07
K041124	Irrigation Tubing Set 2.2M and 3.8M	W&H Dentalwerk Burmoos GmbH	EBW	Class I	2004-06-07
K040933	Ecat Hrrt	Siemens Medical Solutions USA, Inc.	KPS	Class II	2004-06-07
K040767	Synchron Systems Hdl Cholesterol (Hdld) Reagent	Siemens Healthcare Diagnostics Inc.	LBS	Class I	2004-06-07
K040695	21,3-Inch (54Cm) Monochrome Lcd Monitor Me213l (Mdl2108a)	Totoku Electric Co., Ltd.	LLZ	Class II	2004-06-07
K040638	Vnus Radiofrequency Generator, Model Rfg2	Vnus Medical Technologies, Inc.	GEI	Class II	2004-06-07