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 2328 of 3531

510(k) clearances, page 2328 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K924810	Sim/plant	Columbia Scientific, Inc.	JAK	Class II	1993-01-15
K924729	Excel Tripulse Model3000	Excel Tech., Ltd.	GEX	Class II	1993-01-15
K924700	Fisk Headrest	Rhino Mfg.	FQO	Class I	1993-01-15
K924639	New Detector for Transcam/polaris S315	Philips North America LLC	IYX	Class I	1993-01-15
K924489	Software Version A2.5 for Magnetom 42Sp/63sp Syst	Siemens Medical Solutions USA, Inc.	LNH	Class II	1993-01-15
K924423	Mwx-7440 High Speed Bucky	Midwest X-Ray Equipment Co.	KPX	Class II	1993-01-15
K924158	Candela Lasser Systems Modified	Candela Corporation	GEX	Class II	1993-01-15
K924053	Cytoquant Combined Transport Media	Proteins Intl., Inc.	LIO	Class I	1993-01-15
K923981	Ivac Syringe Pump - 740 Series	Y	FRN	Class II	1993-01-15
K923650	Scotty	Mountain Medical Equipment, Inc.	CAW	Class II	1993-01-15
K923584	Therapax Dxt 300 Series 3	Oldelft Corp. of America	JAD	Class II	1993-01-15
K922428	Fukuda Denshi Model Spirosift Sp-5000	Fukuda Denshi USA, Inc.	BZG	Class II	1993-01-15
K922383	The Monitor Model Mi-1.2.3 Tone Count Screen Audio	Monitor Instruments, Inc.	EWO	Class II	1993-01-15
K922289	Sesquipolar(tm) Mis Electrode	Beacon Laboratories, Inc.	GEI	Class II	1993-01-15
K920810	Neo-Stat Dialysate Meter	Automata Medical Instrumentation, Inc.	FIZ	Class II	1993-01-15
K920637	Prime Pca and Pca/continuous Systems	Prime Medical Products, Inc.	MEA	Class II	1993-01-15
K920587	Physiological Measurement and Display Systems	Siemens Medical Solutions USA, Inc.	DQK	Class II	1993-01-15
K915460	Heated Respiratory Humidifier Hc100	Fisher & Paykel Electronics, Ltd.	BTT	Class II	1993-01-15
K914883	Circon Acmi Gen Surg Instru for Mini Invasive Surg	Circon Video	GEI	Class II	1993-01-15
K914521	Diomed 25 Surgical Diode Laser, Gen Surg Applicat	Dio-Med Corp.	GEX	Class II	1993-01-15
K925923	Elias Tmab	Elias U.S.A., Inc.	JZO	Class II	1993-01-14
K925922	Elias Tgab	Elias U.S.A., Inc.	JZO	Class II	1993-01-14
K925902	B-D Loss of Resistance Syringe	BD Becton Dickinson Vacutainer Systems Preanalytic	CAZ	Class II	1993-01-14
K925425	Specific Ige Eia-Turbo Assay	Hycor Biomedical	DHB	Class II	1993-01-14
K924884	Il Test(tm) Pro-Chrom	Instrumentation Laboratory Co.	GGP	Class II	1993-01-14
K924813	Variant Sickle Cell Short Program	Bio-Rad	GKA	Class II	1993-01-14
K924638	Hemochron Direct Draw Aptt/fac VI Vacu-Aptt	Accriva Diagnostics, Inc.	GFO	Class II	1993-01-14
K924319	Dynatron 400	Dynatronics Corp.	LIH	Class II	1993-01-14
K923324	Precision Mist Compressor	Precision Medical, Inc.	CAF	Class II	1993-01-14
K920873	Wedge Pressure Balloon Catheter by J-Lloyd	J-Lloyd Medical, Inc.	DQO	Class II	1993-01-14
K926221	Access Ferritin Assay	Bio-Rad Laboratories Inc.	JMG	Class II	1993-01-13
K925848	Immulite Ferritin	Siemens Healthcare Diagnostics Inc.	JMG	Class II	1993-01-13
K925802	Access Digoxin Assay	Bio-Rad Laboratories Inc.	KXT	Class II	1993-01-13
K925748	Kendall Flat/round & Flat Splittable Silicon Drain	Kendall Healthcare Products Co. Div.Of Tyco Health	GBX	Class I	1993-01-13
K925377	Imx Pap	Abbott Medical	JFH	Class II	1993-01-13
K925282	Urological Catheter and Accessories	Applied Urology, Inc.	FAD	Class II	1993-01-13
K925125	Pro-Step Hcg	Disease Detection International, Inc.	JHI	Class II	1993-01-13
K924904	Hdl-Cholesterol Standard, Modification	Verichem Laboratories, Inc.	JIS	Class II	1993-01-13
K924504	Fast Digoxin Test System	Diatron Corp.	KXT	Class II	1993-01-13
K923996	Disposable Vascular Angioscope	Endovascular, Inc.	LYK	Class II	1993-01-13
K923358	Lc Strip	Genetic Laboratories Wound Care, Inc.	KGX	Class I	1993-01-13
K922970	Intra-Operative Tec Atherectomy System	Intensive Technology, Inc.	MCW	Class II	1993-01-13
K922320	Omni Cystoscope	Expanded Optics, Inc.	FAJ	Class II	1993-01-13
K920869	Flow Directed Thermodilution Balloon Catheter	J-Lloyd Medical, Inc.	DYG	Class II	1993-01-13
K914257	Denture Product X	Essential Dental Systems, Inc.	EFT	Class I	1993-01-13
K926068	Emit(r) II Barbiturate Assay	Syva Co.	DIS	Class II	1993-01-12
K926067	Emit(r) II Benzodiazepine Assay	Syva Co.	JXM	Class II	1993-01-12
K925533	Angestat(r) Pericardial Drainage Sheath Set	Angeion Corp.	GBX	Class I	1993-01-12
K925502	Trace Model# 840, 841,842 & 845 Arm Board	Trace Medical Equipment, Inc.	KMK	Class I	1993-01-12
K925352	Clean Cuff Blood Pressure Cuff Liner	Steridyne Corp.	DXQ	Class II	1993-01-12