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 1354 of 3531

510(k) clearances, page 1354 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K042785	Multi Color Laser Photocoagulator, Model Mc-300	Nidek, Inc.	GEX	Class II	2004-12-14
K042636	Bioplus	Berkeley Advanced Biomaterials	MQV	Class II	2004-12-14
K042592	Intemesh Silicone-Coated Sling and Surgical Mesh with Inhibizone, Model 72403304	American Medical Systems, Inc.	OTN	Class II	2004-12-14
K042584	Opus Minimagnum Anchor with Inserter	Opus Medical, Inc.	HWC	Class II	2004-12-14
K042552	Bio-Core Interference Screw	Zimmer GmbH	HWC	Class II	2004-12-14
K042481	Polaris Pressure Adjustable Valve System, Models Spv-140, Spv-300, Spv-400	Sophysa	JXG	Class II	2004-12-14
K041011	Ultralight II Nd:yag Laser System	Sandstone Medical Technologies, LLC	GEX	Class II	2004-12-14
K040671	Eroject, Miniject, Self Aspirating Syringes, Aspirating Syringes, Non Aspirating Syringes	Anthogyr	EJI	Class II	2004-12-14
K032830	Plla Cannulated Interference Screw	Advanced Biomaterials	HWC	Class II	2004-12-14
K043332	Wheelchair, Model 8500-II	Cycling and Health Tech. Industry R&D Center	IOR	Class I	2004-12-13
K043278	Teratech Model 8Ioc4, 8Iol4 & 10Lap4 Probes	Teratech Corp.	ITX	Class II	2004-12-13
K043148	All Flow Pulmonary Function Filter	Alliance Tech Medical, Inc	CAH	Class II	2004-12-13
K043134	Metrx Workstation	Medical Metrx Solutions, Inc.	LLZ	Class II	2004-12-13
K043092	Preva, 76In Arm, 66In Arm, 56In Arm, Models P7017, P7016, P7015	Progeny, Inc.	EHD	Class II	2004-12-13
K043062	Model Sr-130-D Portable Digital X-Ray System	Source-Ray, Inc.	IZL	Class II	2004-12-13
K042963	Vitek Gram Positive Susceptibility (Gps) Card for Ertapenem	bioMerieux, Inc.	LON	Class II	2004-12-13
K042772	Ebi Array Spinal Fixation System and Spinelink II Spinal Fixation Device	Ebi, LLC	NKB	Class II	2004-12-13
K042532	Biocare Systems Premir 818	Biocare Systems, Inc.	ILY	Class II	2004-12-13
K042489	6F Z4 Guide Catheter	Medtronic, Inc.	DQY	Class II	2004-12-13
K042392	Daptomycin	Ab Biodisk	JWY	Class II	2004-12-13
K041623	Reusable Sterilcontainer Filter Model #Jk090	Aesculap Inc	FRG	Class II	2004-12-13
K041364	Ml830 Laser System	Microlight Corporation of America	ILY	Class II	2004-12-13
K041238	Helicobacter Pylori Igg Elisa	Biohit PLC	LYR	Class I	2004-12-13
K033973	Oxisensor II Recycled Sensor and Oximax Recycled Sensor	Medtronic, Inc.	NLF	Class II	2004-12-13
DEN040010	Vysis Autovysion System	Vysis	NTH	Class II	2004-12-13
K043299	Medley Pca Module, Model 8120	CareFusion 303, Inc	MEA	Class II	2004-12-10
K043298	Blue Orthocord Suture	DePuy Mitek, Inc.	NEW	Class II	2004-12-10
K043287	Palmscan Ap2000; Palmscan A2000; Palmscan P2000	Micromedical Devices, Inc.	IYO	Class II	2004-12-10
K043227	Periarticular Locking Plates, 2358 Series	Zimmer GmbH	HRS	Class II	2004-12-10
K043164	Panalight-Blu, Model 4175	Dusa Pharmaceuticals, Inc.	GEX	Class II	2004-12-10
K043114	Kimberly-Clark Mic-Key Low Profile Gastrostomy Tube	Kimberly-Clark Corporation	KNT	Class II	2004-12-10
K042873	Animas Model Ir1250 Insulin Infusion Pump	Animas Corp.	LZG	Class II	2004-12-10
K042784	Medrad Spectris Solaris Ep Mr Injector System	Medrad, Inc.	DXT	Class II	2004-12-10
K042687	Enzygnost F+2 (Monoclonal) Test Kit	Siemens Healthcare Diagnostics Inc.	MIF	Class II	2004-12-10
K042679	Ir Viewer	Infrared Imaging Systems, Inc.	KZA	Class I	2004-12-10
K042461	Kendall Argyle 2 Fr Double Lumen Neonatal/pediatric Picc, Model 43304	Kendall	LJS	Class II	2004-12-10
K042285	Unicryl M	United Medical Industries Co. Ltd.	NEW	Class II	2004-12-10
K042241	K-Assay Total Ige, K-Assay Ige Calibrator Set, Models Kai-092/Kai-093C	Kamiya Biomedical Company, LLC	DGC	Class II	2004-12-10
K042131	Promedical Surgical Drapes	Promedical Products Co., Ltd.	KKX	Class II	2004-12-10
K042111	Promedical Surgical Gowns	Promedical Products Co., Ltd.	FYA	Class II	2004-12-10
K042099	Tonopach Ultrasonic Tonometer/pachymeter Model P-201 (the Tonopach)	Retinapharma Technologies, Inc.	HKX	Class II	2004-12-10
K041833	Consolidated Sr and Sse Mc-Series Steam Sterilizer	Consolidated Machine Corp.	FLE	Class II	2004-12-10
K041553	Arthrex Suture Grafting Kit	Arthrex GmbH	GAT	Class II	2004-12-10
K032825	Vital Vision Arterial Hardness and Blood Pressure Monitor	Mars Medical Products	DXN	Class II	2004-12-10
K043275	Olympus EU-M60 Eus Exera Endoscopic Ultrasound Center	Olympus Medical Systems Corp.	IYO	Class II	2004-12-09
K043243	Primus Stent and Delivery System	Medtronic, Inc.	FGE	Class II	2004-12-09
K043155	Starion Universal Power Supply (Ups)	Microline Surgical, Inc	HQO	Class II	2004-12-09
K043117	Best Radiopaque Strand; Best Radiopaque Marker	Best Medical International, Inc.	KXK	Class II	2004-12-09
K043110	Microlife Instant Digital Electronic Thermometer, Model Mt18l1	Microlife Intellectual Property GmbH	FLL	Class II	2004-12-09
K043103	Vigilance II Continuous Cardiac Output/oximetry/volumetric Monitor, Model Vig2	Edwards Lifesciences LLC	DXG	Class II	2004-12-09