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 2278 of 3531

510(k) clearances, page 2278 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K925128	The Karl Storz 11274 Series Flexible Fiberscope	Karl Storz Endoscopy-America, Inc.	FGB	Class II	1993-08-18
K923522	Linac-Based Sterotactic Radiosurgery	Radionics Software Applications, Inc.	IYE	Class II	1993-08-18
K923156	Tracheostomy Care Tray	Orion Life Systems, Inc.	JOH	Class II	1993-08-18
K933152	Merocel Merosplint	Merocel Corp.	LYA	Class I	1993-08-17
K932420	Scimed 6 Fr., 7 Fr., and 8 Fr.,triguide Guiding	Scimed Life Systems, Inc.	DQO	Class II	1993-08-17
K930562	Solstar Brillenmode Sunglasses	Solstar Produktions GmbH	HQY	Class I	1993-08-17
K925663	Hgm Aspirating Endoocular(tm) Probe	Hgm, Inc.	HQF	Class II	1993-08-17
K925640	Xomed-Treace EMG Endotracheal Tubeen	Xomed-Treace, Inc.	ETN	Class II	1993-08-17
K921918	Fiber Optic Endoscope	Electro Fiberoptics Corp.	GCM	Class II	1993-08-17
K933408	Fuji Daylight Cassette Multi-Loader	FUJIFILM Healthcare Americas Corporation	IXW	Class II	1993-08-16
K933258	Vidas Theophylline(theo)	Biomerieux Vitek, Inc.	KLS	Class II	1993-08-16
K933253	Superstand 3000	Wuestec Medical, Inc.	IYB	Class I	1993-08-16
K932872	Sickle Cell Test Kit	Histo-Med, Inc.	JBB	Class II	1993-08-16
K932805	10.0Mm Suction/irrigation Probe & Tubing Kit	Mayaguez Medical Center	GCJ	Class II	1993-08-16
K932804	Irrigating Tapered Probe	Mayaguez Medical Center	GCJ	Class II	1993-08-16
K932454	3M Red Dot 2330 Resting EKG Electrode	3M Company	DRX	Class II	1993-08-16
K931925	Tpk Cutaneous Electrode	Staodyne, Inc.	GXY	Class II	1993-08-16
K931777	Apo a-1 Chemiluminescence Assay	Nichols Institute	MSJ	Class I	1993-08-16
K931773	Hdl Precipitating Reagent (Dextran Sulfate)	King Diagnostics, Inc.	LBR	Class I	1993-08-16
K931740	Cotube Estradiol Radioimmunoassay	Bio-Rad	CHP	Class I	1993-08-16
K931704	Immulite Free T4	Siemens Healthcare Diagnostics Inc.	CEC	Class II	1993-08-16
K931703	Immulite Total Ige	Siemens Healthcare Diagnostics Inc.	JHR	Class II	1993-08-16
K931503	Rep Hemoglobin Ief Kits (Cat. No. 3250)	Helena Laboratories, Corp.	JBD	Class II	1993-08-16
K930995	Powdered Examination Gloves	P.T. Healthcare Glovindo	LYY	Class I	1993-08-16
K930499	Grasping Forceps Flexible Stone Dislodger	Endomedix	OCZ	Class II	1993-08-16
K930238	Breast Leakage Inhibitor System: Breast Shields	Prolac, Inc.	HFS	Class I	1993-08-16
K930007	Immulite Tsh Third Generation Control	Siemens Healthcare Diagnostics Inc.	JJX	Class I	1993-08-16
K926514	Endoscopic Ultrasound System Type 20	Olympus Corp.	ODG	Class II	1993-08-16
K926243	Angiographic Catheter	Target Therapeutics	DQO	Class II	1993-08-16
K926059	3M Model 200Rt Rate Taper Infusion Pump	3M Company	FRW	Class I	1993-08-16
K926058	3M Model 280Rt Rate Taper Infusion Pump	3M Company	FRW	Class I	1993-08-16
K925930	Mpc-150 Male to Male Luer Adapter	Molded Products Inc	FPA	Class II	1993-08-16
K925927	Mpc-1000 Injection Cap/plug	Molded Products Inc	FPA	Class II	1993-08-16
K925311	Trilogy Infusion Pump	Ivion Corp.	FRN	Class II	1993-08-16
K925077	Poly-Med Disp. Pers. Prot. Gown Apron & Shoecovers	Medtek Development Corp.	FYC	Class II	1993-08-16
K924385	New Hydrophilic Coating for Wire Guides	Arrow Intl., Inc.	DQX	Class II	1993-08-15
K931721	Il Test Fibrinogen-C	Instrumentation Laboratory Co.	KQJ	Class II	1993-08-13
K932596	Nt4-Plus	Bmr Ent., Inc.	IPF	Class II	1993-08-12
K926519	Surgical Gown	Custom Medical Products, Ltd.	FYA	Class II	1993-08-12
K925085	Escort Spirometer	Vitalograph, Inc.	BZG	Class II	1993-08-12
K933317	Lyphochek Endocrine Control, Levels 1 and 2	Bio-Rad	JJY	Class I	1993-08-11
K932806	Poole Tip Suction Probe & Tubing Kit	Mayaguez Medical Center	GCJ	Class II	1993-08-11
K932542	Scimed 6F Angiographic Catheter	Scimed Life Systems, Inc.	DQO	Class II	1993-08-11
K932449	Dr. Fog	O.R. Concepts, Inc.	OCT	Class II	1993-08-11
K932399	Therapeutic Stim 200 (Ts-200)/200P (Ts-200P)	Myo/Kinetic Systems, Inc.	IPF	Class II	1993-08-11
K931950	Poole Tip Suction Probe	Mayaguez Medical Center	GCY	Class I	1993-08-11
K931299	Histofreezer	Solarcare Technologies Corp,Inc.	GEH	Class II	1993-08-11
K931273	Mist Forceps/clamps for Laparoscopoic/endoscopic	Minimally Invasive Surgical Technologies, Inc.	GCJ	Class II	1993-08-11
K930617	Obgrip and Unitips(tm)	Unisurge, Inc.	GCJ	Class II	1993-08-11
K926510	Staodyn Ems+2	Staodyne, Inc.	IPF	Class II	1993-08-11