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 1546 of 3531

510(k) clearances, page 1546 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K020777	BIPAP Synchrony Ventilatory Support System with Bi-Flex	Respironics, Inc.	MNS	Class II	2002-03-20
K020660	Homepump, Eclipse, C-Series, Painbuster, C-Bloc, on-Q, Easypump, One Step Kvo	Halyard Health	MEB	Class II	2002-03-20
K020590	Model 733Hc Gravity/vacuum Steam Sterilizer	Getinge/Castle, Inc.	FLE	Class II	2002-03-20
K020531	Philips Multi-Parameter Module, Model M3001a; Philips Component Compact Monitor, Release A.02, Model M1275b	Philips North America LLC	MHX	Class II	2002-03-20
K020524	Patientnet Monitoring System	General Electric Medical Systems Information Techn	MSX	Class II	2002-03-20
K020523	Bd Bifurcated Needle, Models 301754, 301755, 301756, 301757	BD	SCL	Class II	2002-03-20
K020331	Pasco Mic and Mic/id Panels	Pasco Laboratories, Inc.	JWY	Class II	2002-03-20
K020316	Cordis Trapease Permanent Vena Cava Filter with the Visease Angiographic Vessel Dilator; Models 466-P306au & 466-P306bu	Cordis US Corp.	DQO	Class II	2002-03-20
K020310	Davlite Microendoscope & Accessories	Davlite Technologies	GCJ	Class II	2002-03-20
K020239	Touch&bond-Plus	Parkell, Inc.	KLE	Class II	2002-03-20
K020136	Visualine Barbiturates Dipstrip Test	Sun Biomedical Laboratories, Inc.	DIS	Class II	2002-03-20
K014280	Latex Examination Glove (Powdered)	Brightway Gloves Pvt., Ltd.	LYY	Class I	2002-03-20
K014279	Latex Examination Gloves (Powder Free)	Brightway Gloves Pvt., Ltd.	LYY	Class I	2002-03-20
K014175	Sulzer Dental Ceramic System-Hexlock	Sulzer Dental, Inc.	NHA	Class II	2002-03-20
K014101	Rapidone-Oxy Test	American Bio Medica Corp.	DJG	Class II	2002-03-20
K013100	Propoxyphene	Abbott Medical	JXN	Class II	2002-03-20
K013001	Methadone	Abbott Medical	DJR	Class II	2002-03-20
K012996	Barbiturates	Abbott Medical	DIS	Class II	2002-03-20
K012989	Dolphin 2000 Oximetry Sensor, Models, 2050, 2351, 2354, 2070	Dolphin Medical, Inc.	DQA	Class II	2002-03-20
K011688	Pelvicflexer Exercise Device	Pelvicflex, Inc.	HIR	Class II	2002-03-20
K011590	Resorb-X Resorbable Plating System	KLS-Martin L.P.	JEY	Class II	2002-03-20
K020526	Modification to Wilson-Cook Multiple Band Ligator	Don Wilson/Wilson-Cook Medical, Inc.	FHN	Class II	2002-03-19
K020500	Univec Bifurcated Sliding Sheath Syringe	Univec, Inc.	SCL	Class II	2002-03-19
K020237	Immunoassay Plus Control, Levels 1, 2, and 3	Consolidated Technology	JJY	Class I	2002-03-19
K014214	Sulzer Dental Ceramic System-Spline	Sulzer Dental, Inc.	DZE	Class II	2002-03-19
K014195	Kayak Hydrophilic Guide Wires	Boston Scientific Corporation	DOX	Class II	2002-03-19
K014172	Nelson Electrosurgical Unit, Model Gn640	Aesculap Inc	GEI	Class II	2002-03-19
K013612	Incare Pelvic Floor Therapy System	Hollister, Inc.	HIR	Class II	2002-03-19
K012825	Hearttrends	Lev-El, Ltd.	DQK	Class II	2002-03-19
K010253	Angio Flow Thermodilution Catheter, Model Af-Cath-01; Angioflow Meter, Models Hq100 and Hq101	Transonic Systems Inc	DYG	Class II	2002-03-19
K020593	Convertors Sms Polyolefin Gown	Medtronic, Inc.	FYA	Class II	2002-03-18
K020069	Medtronic Mida Rex Legend System, Midas Rex Legend Pneumatic High Speed System or Legend System	Medtronic Midas Rex	HBB	Class II	2002-03-18
K020049	Fortaflex Surgical Mesh	Organogenesis, Inc.	FTM	Class II	2002-03-18
K014156	Cerasorb Ortho	Curasan AG	MQV	Class II	2002-03-18
K014155	Opening/closing Wedge Ostetomy Plates	Arthrex GmbH	HRS	Class II	2002-03-18
K014154	Vilex/duval/orthex Cannulated Bone Screw Db1 Thread, Model F25-Xx-09; Vilex Solid Bone Screws Db1 Thread,model F20-Xx-00	Vilex, Inc.	HWC	Class II	2002-03-18
K014149	Paediscope, Model # P010a and Pf011a	Aesculap Inc	GWG	Class II	2002-03-18
K013201	Cardiofocus Diode Laser System, Models 60R, 60Nr, 30Nr	CardioFocus, Inc.	GEX	Class II	2002-03-18
K020645	Modification to the Maestro System	BioHorizons Implant Systems Inc	DZE	Class II	2002-03-15
K020632	Enguard Remote Patient Monitor	Mennen Medical, Inc.	QYX	Class II	2002-03-15
K020536	Gazelle Wheelchair	Alum Creek Wheelchair Co., Inc.	IOR	Class I	2002-03-15
K020437	Classic TENS	Care Rehab, Inc.	GZJ	Class II	2002-03-15
K020217	Acs:180 and Advia Centaur Ipth Immunoassay	Bayer Diagnostics Corp.	JJX	Class I	2002-03-15
K020195	Simidur S1s	Wieland Dental + Technik GmbH & Co. KG	EJS	Class II	2002-03-15
K020194	Simidur Kf Plus	Wieland Dental + Technik GmbH & Co. KG	EJS	Class II	2002-03-15
K020192	Simidur S2	Wieland Dental + Technik GmbH & Co. KG	EJS	Class II	2002-03-15
K020178	Belleglass Hp Modeling Gel	Kerr Dental Materials Center	EBG	Class II	2002-03-15
K020126	Modification to Surx Radiofrequency Electrosurgical Generator System and Accessories (Surx Tv System)	Surx, Inc.	MUK	Class II	2002-03-15
K020097	Stryker Interference Screw Cross Pin System	Stryker Corp.	JDW	Class II	2002-03-15
K020055	Philips Integris Allura 9 with Fd Option	Philips North America LLC	JAA	Class II	2002-03-15