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 2026-10-12, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,969 of the 176,366 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	2,569

176,366 records, page 3238 of 3528

510(k) clearances, page 3238 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K820597	158 Blood Gas Analyzer	Corning Medical & Scientific	CHL	Class II	1982-03-26
K820596	Cyanmethemoglobin Test	Boehringer Mannheim Corp.	KHG	Class II	1982-03-26
K820590	Orthopedic Soft Goods	Abco Dealers, Inc.	ILI	Class I	1982-03-26
K820587	Wet Pack Line of Products	Abco Dealers, Inc.	KMJ	Class I	1982-03-26
K820528	Pflex Tm	Health Scan, Inc.	BWF	Class II	1982-03-26
K820512	7Cm Berman Airway	Vital Signs, Inc.	CAE	Class I	1982-03-26
K820508	Mem Non-Essential Amino Acids (100X)	Dutchland Laboratories, Inc.	KIT	Class I	1982-03-26
K820495	Sodium Pyruvate (100Mm)	Dutchland Laboratories, Inc.	KIT	Class I	1982-03-26
K820482	Accu-Rynge Insulin Pump #Sp-250	Delta Medical Industries	FRN	Class II	1982-03-26
K820451	Introducer for Endotracheal Tube	Imed Corp.	BWB	Class I	1982-03-26
K820450	Thromboscreen	Pacific Hemostasis	GIT	Class II	1982-03-26
K820437	Aves Wright Stain	Helena Laboratories, Corp.	IAF	Class I	1982-03-26
K820374	Jls Group Infant Monitor	Jls Group, Inc.	BZQ	Class II	1982-03-26
K820365	Mark 100 & 300 Ultrasound System	Advanced Technology Laboratories, Inc.	IYO	Class II	1982-03-26
K820364	Mark 500 Ultrasouond System	Advanced Technology Laboratories, Inc.	IYO	Class II	1982-03-26
K820358	Follicle Stimulating Hormone Kit	Pcl-Ria, Inc.	CGJ	Class I	1982-03-26
K820268	Adaptaid Temp. Pacing Ext. Lead #366-02	Intermedics, Inc.	DSA	Class II	1982-03-26
K820240	Papillotomes	American Endoscopy, Inc.	KNS	Class II	1982-03-26
K820239	Retrieval Forceps	American Endoscopy, Inc.	KOD	Class II	1982-03-26
K820193	Gore-Tex Tissue Reinforcement Patch	W. L. Gore & Associates, Inc.	FTL	Class II	1982-03-26
K820059	Resuscitation Mask	Cederroth, Inc. USA	BTM	Class II	1982-03-26
K820003	Cardiovascular Temp. Pacemaker Elec	Diag Corp.	LDF	Class II	1982-03-26
K813572	Centria Prolactin Test Set	Ventrex Laboratories, Inc.	CFT	Class I	1982-03-26
K813459	Reusable & Disposable Temp. Probes	Electromedics, Inc.	FLL	Class II	1982-03-26
K812961	Sheffield Infant Ventilator Mark 4	Cairco, Ltd.	CBK	Class II	1982-03-26
K827036	Auto Sector Mcu	Technicare Corp.			1982-03-25
K820677	Touch Flush Continuous Fast/flush	Norton Performance Plastics Corp.	DRS	Class II	1982-03-25
K820676	Touch Flush W/y Transducer Connector	Norton Performance Plastics Corp.	DRS	Class II	1982-03-25
K820674	Opticath	Oximetrix, Inc.	DQE	Class II	1982-03-25
K820646	Atrac Tm Multipurpose Balloon Catheter	Atrium Medical Corporation	DXE	Class II	1982-03-25
K820637	Cath-Hold	Womco Products	KOD	Class II	1982-03-25
K820632	Colorimetric Uric Acid Reagent Set	Biorent Diagnostic, Inc.	KNK	Class I	1982-03-25
K820629	Corning 902 Sodium Potassium Analyzer	Corning Medical & Scientific	CFM	Class I	1982-03-25
K820617	Dispersed Phase Alloy	Goldsmith & Revere, Inc.	EJJ	Class II	1982-03-25
K820584	Decubicare Pads & Accessories	Abco Dealers, Inc.	FMP	Class I	1982-03-25
K820526	Relief Valve-Honan Intraoc. Pressure	The Lebanon Corp.	LCC	Class II	1982-03-25
K820468	Profile General Set Assayed Serum Contr	General Diagnostics	DIF	Class I	1982-03-25
K820357	Luteinizing Hormone Kit	Pcl-Ria, Inc.	CEP	Class I	1982-03-25
K820319	Fetal-Tek Control Mature	Helena Laboratories, Corp.	JJS	Class I	1982-03-25
K820300	Electronic Digital Sphygmomanometer	Copal, Inc.	DXN	Class II	1982-03-25
K820243	Continuous Blood Processor Cbp-6000 &	Bentley Laboratories, Inc.	KDI	Class II	1982-03-25
K813596	Auto Sector Mcu	Technicare Corp.	IYO	Class II	1982-03-25
K813431	Salicylates	Bio-Analytics Laboratories, Inc.	DKJ	Class II	1982-03-25
K813256	Hypodermic & Suture Needles	Needle Industries(Usa), Inc.	FMI	Class II	1982-03-25
K820678	System 10	Biostim, Inc.	GZJ	Class II	1982-03-23
K820606	Monaghan's True Volume Exerciser	Monaghan Medical Corp.	BWF	Class II	1982-03-23
K820605	Ote Biomedica Neurograph 18	Del Mar Avionics	GWQ	Class II	1982-03-23
K820604	Ote Biomedica Neurograph 9	Del Mar Avionics	GWQ	Class II	1982-03-23
K820603	Ote Biomedica Neurograph 14	Del Mar Avionics	GWQ	Class II	1982-03-23
K820601	Replacement Saw Blades for Stryker Air	Micro-Aire Surgical Instruments, Inc.	GFA	Class I	1982-03-23