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 2682 of 3530

510(k) clearances, page 2682 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K884124	Automated Eia Reader Model El311	Bio-Tek Instruments, Inc.	JJQ	Class I	1989-01-03
K883742	Modified Tsh Irma Kit	Pacific Biotech, Inc.	JLW	Class II	1989-01-03
K883728	Auto Impedance Meter Ae105 & Ae106 W/audiometer	American Electromedics Corp.	ETY	Class II	1989-01-03
K882225	-Amylase Eps	Boehringer Mannheim Corp.	CIJ	Class II	1989-01-03
K885163	Dioptics Eyeshields	Dioptics	HOY	Class I	1988-12-30
K885076	Coag-a-Mate Xc/xc Plus Version D.00 Software	bioMerieux, Inc.	JPA	Class II	1988-12-30
K884669	Exel 2002 & 2002Fs CT Scanner	Elscint, Inc.	JAK	Class II	1988-12-30
K884668	Exel 1002 CT Scanner	Elscint, Inc.	JAK	Class II	1988-12-30
K884667	Exel 905 Series CT Scanner	Elscint, Inc.	JAK	Class II	1988-12-30
K884551	Dade Factor IX Chromogenic Assay	Baxter Healthcare Corporation	GGP	Class II	1988-12-30
K884544	Dade Factor VIII Chromogenic Assay	Baxter Healthcare Corporation	GGP	Class II	1988-12-30
K882830	Infusion Pump	Pemlab Corp.	LZF	Class II	1988-12-30
K881648	Transfer Container Humidifier	Newport Biosystems, Inc.	CAF	Class II	1988-12-30
K885044	Behring Polaroid Opus Theophylline	Pb Diagnostic Systems, Inc.	KLS	Class II	1988-12-29
K884993	Visual Blood Glucose Test System	Diagnostic Systems	CGA	Class II	1988-12-29
K884888	Modified New Jersey Acetabular Comp. & Bone Screws	Protek, Inc.	JDI	Class II	1988-12-29
K884784	Virgo(r) Microwell Alt Assay	Electro-Nucleonics, Inc.	CKD	Class I	1988-12-29
K884537	Ae-800Pa EEG Module	Nihon Kohden America Inc	GWQ	Class II	1988-12-29
K884414	Clensatron Automatic Contact Lens Cleaner	Questech Intl., Inc.	LYL	Class II	1988-12-29
K884263	Rogozinski Spinal System	Richards Medical Co., Inc.	KWP	Class II	1988-12-29
K884242	Modified Chick Ambulatory Halo	Chick Medical Products	JEC	Class II	1988-12-29
K884035	Saitron 430 Random Access Chemistry Analyzer	Sclavo, Inc.	JJE	Class I	1988-12-29
K883340	Neural Magnetic Stimulator, the D190	Tracor Northern, Inc.	GWF	Class II	1988-12-29
K885132	Facsmate Sample Handling Device	BD Becton Dickinson Vacutainer Systems Preanalytic	GKL	Class II	1988-12-28
K885121	Cell Scraper	BD Becton Dickinson Vacutainer Systems Preanalytic	KJA	Class I	1988-12-28
K885093	Coulter Stks	Coulter Electronics, Inc.	GKZ	Class II	1988-12-28
K884955	Cardiocap(tm) Cm-104 Monitor	Datex Division Instrumentarium Corp.	DXN	Class II	1988-12-28
K884891	Oc-100 Oximeter Interface Calibrator	Telediagnostic Systems, Inc.	DQA	Class II	1988-12-28
K884485	Kd Activated Partial Thromboplastin Time Reagent	King Diagnostics, Inc.	GFO	Class II	1988-12-28
K884385	Fibri-Prest/thrombin-Prest Controls	American Bioproducts Co.	GJA	Class II	1988-12-28
K884384	Thrombin-Prest Reagent Kit	American Bioproducts Co.	GJA	Class II	1988-12-28
K884351	Unirest Pl, Ante./post. Restorative, Paste/liquid	Scientific Pharmaceuticals, Inc.	EBF	Class II	1988-12-28
K884251	Allergan Lens Case	Allergan Optical	LRX	Class II	1988-12-28
K884153	Candela Miniflex Deflectable Ureteroscope	Candela Corporation	FGB	Class II	1988-12-28
K883618	Perfecta II Total Hip System	Orthomet, Inc.	JDI	Class II	1988-12-28
K883617	Lifepak 50 Monitor/defibrillator	Physio Control, Inc.	LDD	Class II	1988-12-28
K883315	Edentrace Multi-Charter Model 3700	Edentec Corp.	DSF	Class I	1988-12-28
K882717	Procedure Packs Contrast Media Sets	Procedure Packs, Inc.	DTL	Class II	1988-12-28
K885106	Removable Battery Power System	Rolcontrol Products, Co., Inc.	KNN	Class I	1988-12-27
K885105	Sliding Arm Support	Rolcontrol Products, Co., Inc.	KNN	Class I	1988-12-27
K885104	Laydown Arm Support Mechanism	Rolcontrol Products, Co., Inc.	KNN	Class I	1988-12-27
K885103	1600 Light Touch Control	Rolcontrol Products, Co., Inc.	ITI	Class II	1988-12-27
K885062	Modified Q-Series of Treadmills	Quinton, Inc.	IOL	Class I	1988-12-27
K884956	Cardiocap(tm) Cto-104 Monitor	Datex Division Instrumentarium Corp.	DPS	Class II	1988-12-27
K884908	Ultraflotation Medical Wheelchair	Medical Flotation Systems, Inc.	INF	Class I	1988-12-27
K884907	Bumpy Medical Massage Mat	Medical Flotation Systems, Inc.	LYG	Class I	1988-12-27
K884862	Anchor Double-Edge Myringotomy Blade	Anchor Products Co.	GES	Class I	1988-12-27
K884821	Abbott Spectrum(r) Bicarbonate Reagent	Abbott Medical	KHS	Class II	1988-12-27
K884812	Karma-Rs, Karma-Fs Wheelchairs	Orthofab, Inc.	ITI	Class II	1988-12-27
K884683	Ferritin Serozyme Immunoenzymetric Assay	Serono-Baker Diagnostics, Inc.	DBF	Class II	1988-12-27