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 890 of 3530

510(k) clearances, page 890 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K120636	Synapse 3D Cardiac Tools	FUJIFILM Healthcare Americas Corporation	LLZ	Class II	2012-07-05
K120530	Dentin Dental Implants System: Rapid, Classic, Prestige, One Piece, Dentin Dental Abutment System / Dentin Restoration S	Dentin Implants Technologies Ltd.	DZE	Class II	2012-07-05
K120514	Cardiopacs	Lumedx	LLZ	Class II	2012-07-05
K120338	Atlantis in Zirconia for Dentsply Ankylos Implant, Atlantis Later Abutment in Zirconia	Astra Tech, Inc.	NHA	Class II	2012-07-05
K120244	Spectrashield 9500 Surgical N95 Respirator	Nexera Medical LLC	ONT	Class II	2012-07-05
K120138	Bd Max Mrsa Assay, Bd Max Instrument	BD Diagnostics (Geneohm Sciences Canada, Inc)	NQX	Class II	2012-07-05
K112331	Biopure Portable Ro Systems	Arion Water, Inc.	FIP	Class II	2012-07-05
K111454	Iluminage Diode Laser	Cynosure, LLC	OHS	Class II	2012-07-05
K121871	Airstrip Remote Patient Monitoring (Rpm) Remote Data Viewing	AirStrip Technologies, Inc.	MWI	Class II	2012-07-03
K121669	Warmair Model 135 Hyperthermia System (Controller and Blankets)	Gentherm Medical, LLC	DWJ	Class II	2012-07-03
K121629	Cook Celect Platinum Vena Cava Filter Set for Femoral Approach Cook Celect Platium Vena Cava Filter Set for Jugular Appr	William Cook Europe ApS	DTK	Class II	2012-07-03
K121506	Utb Blue Powder Free Nitrile	Northstar Healthcare Holdings	LZA	Class I	2012-07-03
K121336	Modified Surgiquest Airseal Optical Trocar & Cannula System with Integrated Insufflator Dpis 2000	Surgiquest, Inc.	HIF	Class II	2012-07-03
K121122	Detectabuse Liquid Control, Detectabuse Stat-Skreen Liquid Control	Biochemical Diagnostic, Inc.	DIF	Class I	2012-07-03
K121107	Fortify Integrated Corpectomy Spacers, (Fortify I and Fortify I-R)	Globus Medical, Inc.	MQP	Class II	2012-07-03
K121060	Spine Frontier Indus Acp System	SPINEFRONTIER, Inc. dba LESspine Innovations	KWQ	Class II	2012-07-03
K120966	Depuy Pulse Lumbar Cage System	Medos International SARL	MAX	Class II	2012-07-03
K120941	Constant Care Lilah Home Health Monitoring System	Constant Care, LLC	DRG	Class II	2012-07-03
K120884	Pericam Psi	Perimed AB	DPT	Class II	2012-07-03
K120634	U-Right Td-3124 Blood Pressure Monitoring System	Taidoc Technology Corporation	DXN	Class II	2012-07-03
K120177	Spinal Elements Cerclage System	Spinal Elements, Inc	JDQ	Class II	2012-07-03
K113262	Ace Cholesterol Reagent, Ace Hdl-C Reagent, Ace Ldl-C Reagent-C, Ace-Trislycerides Reagent	Alfa Wassermann Diagnostic Technologies, Inc.	CHH	Class I	2012-07-03
K113056	Orange Colored Condoms Orange Scent	Karex Industries Sdn Bhd	HIS	Class II	2012-07-03
K112634	Natrox Topical Oxygen Delivery System with Iodp	Inotec AMD Ltd.	KPJ	Class II	2012-07-03
K103577	Trinon Q & Q3 Implant System	Trinon Titanium GmbH	DZE	Class II	2012-07-03
K121609	Asthmapolis System	Reciprocal Labs Corporation	CAF	Class II	2012-07-02
K121448	Oncentra, Oncentra External Beam, Oncentra Brachy	Elekta Inc. D/B/A Nucletron Corporation	MUJ	Class II	2012-07-02
K120285	K Series CPAP System with Heated Humidifer	Curative Medical, Inc.	BZD	Class II	2012-07-02
K113435	Ace Carbon Dioxide(co2-Lc) Reagent, Ace Direct Bilirubin Reagent, Ace Total Bilirubin Reagent, Ace Magnesium Reagent	Alfa Wassermann	KHS	Class II	2012-07-02
K121701	Systems Integration	Olympus Medical Systems Corp.	GCJ	Class II	2012-06-29
K121634	Interlink System Extension Set with Control-a-Flo-Regulatory Clearlink System Extension Set with Control-a-Flo-Regulator	Baxter Healthcare Corporation	FPA	Class II	2012-06-29
K121574	Synthes Matrixmadible Plate and Screw System	Synthes GmbH	JEY	Class II	2012-06-29
K121333	Wave D Cage	Advanced Medical Technologies AG	MAX	Class II	2012-06-29
K121332	Loop Cage	Advanced Medical Technologies AG	MAX	Class II	2012-06-29
K121330	Wave O Cage	Advanced Medical Technologies AG	MAX	Class II	2012-06-29
K121288	Fuse Cage	Advanced Medical Technologies AG	MAX	Class II	2012-06-29
K121191	Vertex Rcconstruction System	Medtronic Sofamor Danek	KWP	Class II	2012-06-29
K121175	Flash Pta Ballon Dilatation Catheter-5Mm X 19Mm X 135Cm	Verge Medical Inc.	LIT	Class II	2012-06-29
K121092	Flowease [Subcutaneous] Infusion Set	Baxter Healthcare Corporation	FPA	Class II	2012-06-29
K120990	Nexgen Lcck Trabecular Metal (Tm) Coupled Tibial Cones Provisionals to Nexgen Lcck Trabecular Metal (Tm) Coupled Tibial	Zimmer Trabecular Metal Technology, Inc.	MBH	Class II	2012-06-29
K120963	Powder Free Natural Rubber Latex Examination Gloves	Medtexx Manufacturing Sdn. Bhd.	LYY	Class I	2012-06-29
K120897	Progrip Laparscopic Self-Fixating Mesh	Sofradim Production	FTL	Class II	2012-06-29
K120855	Intellispace ECG	Philips Health Care	DQK	Class II	2012-06-29
K120581	Sc Tip Cleaner	Nsi	GEI	Class II	2012-06-29
K120520	Exactrac Robotics Novalis Robotics	Brainlab, Inc.	JAI	Class II	2012-06-29
K120459	Steerable Guiding Sheath, Model Adelante Destino	Oscor Inc.	DYB	Class II	2012-06-29
K120260	Icta	Excel-Tech Ltd. (Xltek)	OMB	Class II	2012-06-29
K120218	Tek USA E-Generator Integrated LED Handpiece (High & Low Speed Air Turbnine Dental Handpiece)	Palm Beach Dental Supply D/B/A Tek USA	EFB	Class I	2012-06-29
K120193	Any View Patient Monitors	Guangdong Biolight Meditech Co., Ltd	MWI	Class II	2012-06-29
K113775	Flash-C Ptca Balloon Dilatation Catheter- 4.0Mm X 14Mm X 135Cm -4.0Mm X 19Mm X 135Cm- 4.5Mm X 14Mm X 135Cm-4.5Mm X 19Mm	Verge Medical Inc.	LOX	Class II	2012-06-29