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 2026-10-22, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 2867 of 3529

510(k) clearances, page 2867 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K863365	Modification of Sterility Cycle Parameters	Coratomic, Inc.	DXY	Class III	1986-10-08
K863345	Tandem(r)-M Ferritin Immunoenzymetric Assay	Hybritech, Inc.	DBF	Class II	1986-10-08
K863238	Reads RF Test Kit for Igm Rheumatoid Factor	Biostar Medical Products, Inc.	DHR	Class II	1986-10-08
K861852	Csi/mpr or Csi/mpr Plus	Columbia Scientific, Inc.	LLZ	Class II	1986-10-08
K863758	Ortho-Bite Wax Wafer	Columbus Dental Mfg. Co.	EGD	Class I	1986-10-07
K863745	Abnormal Spinal Fluid Control	Ciba Corning Diagnostics Corp.	JJY	Class I	1986-10-07
K863683	Bard Harvard(tm) Pca Jr Intermittent Infusion Pump	C.R. Bard Inc	FRN	Class II	1986-10-07
K863653	Suction-Off	B & B Medical Technologies, Inc.	HXD	Class I	1986-10-07
K863382	Cannon Nasal Splint	Treace Medical, Inc.	EPP	Class I	1986-10-07
K863339	Dura Neb(tm) 2000 Portable Compressor	Thera Tec, Inc.	BTI	Class II	1986-10-07
K863174	Caulk's Polishing Paste	Dentsply Intl.	EBF	Class II	1986-10-07
K862568	Lds - Laser Delivery System	Coherent Medical Group	HQF	Class II	1986-10-07
K862562	Punch Biopsy Kit	Clinipad Corp.	KNW	Class II	1986-10-07
K862447	Pancoat T3 Uptake Coated Tube Radioimmunoassay Kit	Pantex, Div. Bio-Analysis, Inc.	KHQ	Class II	1986-10-07
K862317	CT Max, Catalog No. B7940 Ha	General Electric Co.	JAK	Class II	1986-10-07
K861426	Screw-Vent (Tm) Implant/endosseous Screw Implant	Core-Vent Corp.	DZE	Class II	1986-10-07
K863749	Teca/ecem T5 Portable Electroencephalograph	Teca, Inc.	GWQ	Class II	1986-10-06
K863677	Tradition High Speed Handpiece	Midwest	EFB	Class I	1986-10-06
K863658	Salter Labs 3000 Series Percussors	Salter Labs	BYI	Class II	1986-10-06
K863656	Salter Voluchek 6600	Salter Labs	BZG	Class II	1986-10-06
K863636	Updated Sterile General Hospital Instruments	Biological & Environmental Control Laboratories			1986-10-06
K863621	Pals	West Lake Marketing	FMK	Class II	1986-10-06
K863557	Blade, Surgical Preparation Razor, Straight,single	American Safety Razor Co.			1986-10-06
K863554	Thackray Cruciate Sparing Knee Cs-1	Thackray USA			1986-10-06
K863520	CO2 Laser Micromanipulator	Laser Spectrum, Inc.	HHR	Class II	1986-10-06
K863497	Suction Catheter Kit	Welmed Systems, Inc.	BSY	Class I	1986-10-06
K863331	Siredoc 60 and Siredoc 220	Siemens Medical Solutions USA, Inc.	DSF	Class I	1986-10-06
K863159	Q4000 and Q3040 Electrocardiograph Monitor	Quinton, Inc.	DSI	Class II	1986-10-06
K863028	Rosstec Implant System for Edosteal Implantology	Ross Implant Technologies Corp., Inc.	DZE	Class II	1986-10-06
K862915	Multistim(4-Channel), Multistim-Octrode(8 Channel)	Neuromed, Inc.	GZB	Class II	1986-10-06
K862527	Sleep Analyzing Computer	Micro Tronics Corp.	OLZ	Class II	1986-10-06
K862460	Femoral Hemi-Hip Prosthesis	Orthopaedic Device Corp.	KWY	Class II	1986-10-06
K853770	Codman Disposable Plastic Intracranial Press/kit	Cerenovus, Inc.	GWM	Class II	1986-10-06
K863789	Corning Elisa Plates	Corning Medical & Scientific	LIB	Class I	1986-10-03
K863671	Pennine Leg Bag 350Ml Cat.no.db3 & 500Ml.cat.#db5	Samco Industries, Inc.	KNX	Class II	1986-10-03
K863622	Tdx(r) Amylase II	Abbott Medical	JFJ	Class II	1986-10-03
K863605	Arthroscopic Irrigation Pump	American Edwards Laboratories	HRX	Class II	1986-10-03
K863604	Disposable Blades for Arthroscopic Surgical Device	American Edwards Laboratories			1986-10-03
K863587	Creatine Phosphokinase(ck) Procedure	Data Medical Associates, Inc.	CGS	Class II	1986-10-03
K863586	Gamma Glutamyl Transferase Procedure	Data Medical Associates, Inc.	JPZ	Class I	1986-10-03
K863551	Modified Medi-Quet Tourniquet, Model #2740-00	Depuy, Inc.			1986-10-03
K863503	Hemolyse	Reagent Laboratory, Inc.	GGK	Class I	1986-10-03
K863302	Modified Foley Catheter	Sheridan Catheter Corp.	KOD	Class II	1986-10-03
K863255	Lactate Dehydrogenase(ld) Procedure	Data Medical Associates, Inc.	CFJ	Class II	1986-10-03
K863208	Ohmeda Auxiliary Power System	GE Healthcare	FMT	Class II	1986-10-03
K863036	Phadebas Rast/phadezym Rast Allertube	Pharmacia, Inc.	DHB	Class II	1986-10-03
K862753	Tandem Suction Cautery	Celebration Designs, Inc.	GEI	Class II	1986-10-03
K862669	Activated Partial Thromboplastin Time Test	U. S. Diagnostics, Inc.	GFD	Class I	1986-10-03
K862645	Clinac (R) C Series (400C, 600C, 2100C, 2500C)	Varian Assoc., Inc.	IYE	Class II	1986-10-03
K862090	Mcgaw Nutra-Feed Efs Enteral Feeding Bag	Kendall Mcgaw Laboratories, Inc.	FPD	Class II	1986-10-03