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 2559 of 3530

510(k) clearances, page 2559 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K896780	Micro Dau Benzodiazepine Enzyme Immunoassay Kit	IMMUNOTECH s.r.o.	JXM	Class II	1990-03-23
K896723	Clip Gun with Raney Type Scalp Clips	Omni Medical Designs	HBO	Class II	1990-03-23
K896670	Tip Top(r) Dispenser Caps	Helena Laboratories, Corp.	GJW	Class I	1990-03-23
K895992	Catheter Extension Set Cat. No. 48-3027-9	National Medical Care, Medical Products Div., Inc.	KDJ	Class II	1990-03-23
K895792	Dextrolyte II Capd Transfer Set - No. 48-4009-6	National Medical Care, Medical Products Div., Inc.	KDJ	Class II	1990-03-23
K894947	Platelia Toxo Igg Kit	Kallestad Diag, A Div. of Erbamont, Inc.	LGO	Class I	1990-03-23
K892425	Stp Complete Module Set	Leibinger & Fischer, Ltd.	IYE	Class II	1990-03-23
K891993	Collagen Neurosponge	Vitaphore Corp.	HBA	Class II	1990-03-23
K900629	Bernsco Luer Needler Adaptor	Bernsco Surgical Supply, Inc.	GEI	Class II	1990-03-22
K900463	Laser Delivery Systems, Fiberoptics & Contact Tips	Ximed Medical Systems	GEX	Class II	1990-03-22
K900323	Peritoneal Dialysis Cycler Set	National Medical Care, Medical Products Div., Inc.	KDJ	Class II	1990-03-22
K900243	Dextrolyte II, Peritoneal Dialysis No. 48-1015-6	National Medical Care, Medical Products Div., Inc.	KDJ	Class II	1990-03-22
K900242	Dextrolyte II, Peritoneal Dialysis No. 48-1031-3	National Medical Care, Medical Products Div., Inc.	KDJ	Class II	1990-03-22
K900226	Dextrolyte II, Peritoneal Dialysis No. 48-1001-6	National Medical Care, Medical Products Div., Inc.	KDJ	Class II	1990-03-22
K900165	Nidek, Inc. Bio-Dc Laser Delivery System	Nidek, Inc.	GEX	Class II	1990-03-22
K900142	Dextrolyte II, W/5 Prong Manifold No. 48-1003-2	National Medical Care, Medical Products Div., Inc.	KDJ	Class II	1990-03-22
K900141	Dextrolyte II, W/5 Prong Manifold No. 48-1100-6	National Medical Care, Medical Products Div., Inc.	KDJ	Class II	1990-03-22
K900140	Dextrolyte II, Peritoneal Dialysis Cycler Set W/3	National Medical Care, Medical Products Div., Inc.	KDJ	Class II	1990-03-22
K900076	Sharplan Flexible CO2 Surgical Laser Applicator	Sharplan Lasers, Inc.	GEX	Class II	1990-03-22
K900012	Dextrolyte II, Peritoneal Dialysis Cycler Set	National Medical Care, Medical Products Div., Inc.	KDJ	Class II	1990-03-22
K900008	Dextrolyte II, Peritoneal Dialysis Cycler Set	National Medical Care, Medical Products Div., Inc.	KDJ	Class II	1990-03-22
K897054	Clinical Mercury Thermometer	Cypress Medical Products LLC	FLK	Class II	1990-03-22
K896600	Dextrolyte II, Single Use Y Set No. 48-6360-1	National Medical Care, Medical Products Div., Inc.	KDJ	Class II	1990-03-22
K896599	Dextrolyte II, Peritoneal Dialysis Cycler Set -(8)	National Medical Care, Medical Products Div., Inc.	KDJ	Class II	1990-03-22
K896205	Monoscopy Brand, 5 Mm Locking Trocar Sleeve	Dexide, Inc.	GCI	Class II	1990-03-22
K895991	Peritoneal Dialysis Drainage Set No. 48-0025-6	National Medical Care, Medical Products Div., Inc.	KDJ	Class II	1990-03-22
K895990	Dextrolyte II Peritoneal Dialysis Cycler Set	National Medical Care, Medical Products Div., Inc.	KDJ	Class II	1990-03-22
K895326	Eub-165	Hitachi Medical Corp. of America	DXK	Class II	1990-03-22
K895168	Uro-Baggie	Cwt Workshop	KNX	Class II	1990-03-22
K900836	Osteonics Ecsi Hip Stem Series	Osteonics Corp.	JDI	Class II	1990-03-21
K901154	Microtek's Surgical Lamp Handle & Cover	Microbio-Medics, Inc.	FTA	Class II	1990-03-20
K900985	Surgeons' Gloves W/hypoallergenicity Claims	Productes del Latex, S.A.	KGO	Class I	1990-03-20
K900492	Labeling Change - Viaspan(tm) (Belzer Uw)	The du Pont Co.	KDL	Class II	1990-03-20
K900138	Motech Titanium Surgical Mesh	Biedermann Motech GmbH	EZX	Class II	1990-03-20
K900122	Auto Suture Latchless Absorbable Hemostatic Clip*	United States Surgical, A Division of Tyco Healthc	FZP	Class II	1990-03-20
K896060	Erection Inducer Device (Eid)	Performance Medical, Inc.	LKY	Class II	1990-03-20
K895296	Selby II Instrumentation	Advanced Spine Fixation	KWP	Class II	1990-03-20
K893130	EMG Navigator & EMG Traveler	Bio-Logic Systems Corp.	IKN	Class II	1990-03-20
K901073	Anti-Rnp Microassay	Diamedix Corp.	LLL	Class II	1990-03-19
K900902	Iron Liquid Stable Reagent	Medical Analysis Systems, Inc.	JIY	Class I	1990-03-19
K900642	Swivel Adapter	Williams Specialty Products, Inc.	HHI	Class II	1990-03-19
K900519	Classic Ecg/stimulating No. 1700 Series	Classic Medical Products, Inc.	DRX	Class II	1990-03-19
K900516	Water Jel Sterile Gel-Soaked Burn Dressing	Trilling Medical Technologies, Inc.	FRO	Unclassified	1990-03-19
K900379	Hycult Diamond Coronary Bypass Knife	Abbott Medical	DWS	Class I	1990-03-19
K900283	Mrt 50A Software Release 9.0	Toshiba America Mri, Inc.	LNH	Class II	1990-03-19
K900211	Skytron Universe Series Surgical Lights	Skytron, LLC	FSY	Class II	1990-03-19
K900153	Sharplan Nd:yag Disposable Fiber Delivery System	Sharplan Lasers, Inc.	GEX	Class II	1990-03-19
K900086	Hemorrhoidal Ligator with Suction	Baxter Healthcare Corporation	KDH	Class II	1990-03-19
K900066	Flexiguide(tm) CO2 Laser Hollow Flexible Fiber	Luxar Corp.	GEX	Class II	1990-03-19
K897197	Advance Pressure Monitor Line, High Pres., Admini.	Advance Medical Designs Inc	DTL	Class II	1990-03-19