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 1924 of 3531

510(k) clearances, page 1924 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K963100	Tronzo Acetabular Fixation Component (1 99-02-00Xx (Ace. Fixation Cup) Xx=od of Ace. Cup	Endotec, Inc.	LPH	Class II	1997-02-12
K963004	Bionect Cream	Fidia Pharmaceutical Corp.	MGQ	Unclassified	1997-02-12
K962717	6 French, 7 French, and 8 French Guiding Catheters with Phosphorylcholine (Pc) Polymer Coating	Biocompatibles Cardiovascular, Inc.	DQY	Class II	1997-02-12
K970248	Cantrol Serum Iron and Total Iron Binding Capacity Test System	Canyon Diagnostics, Inc.	JQE	Class I	1997-02-11
K964858	Bemis Two Gallon Chemotherapy Container	Bemis Mfg. Co.	MMK	Class II	1997-02-11
K964854	Medrad Phased Array 1.5T Shoulder Imaging Surgace Coil	Medrad, Inc.	MOS	Class II	1997-02-11
K964840	Beam Block Trays	Aktina Medical Physics Corp.	IYE	Class II	1997-02-11
K964803	Univision Echocardiology System	Network Concepts, Inc.	LMB	Class I	1997-02-11
K964753	Matrix 3000 Flexible Spine Coil	Us Asia Instruments, Inc.	LNH	Class II	1997-02-11
K964740	The Nomos Minicrane	Nomos Corp.	JAI	Class II	1997-02-11
K964697	Amd Home Health Monitor System and Amd Monitoring Station	Advance Medical Device, Inc.	DXN	Class II	1997-02-11
K964678	Phased Array Neck Coil	Philips North America LLC	MOS	Class II	1997-02-11
K964657	Super K-Amp, Ez-Compression, Trim-Pro, HF-Pro, Enviro-Pro, Compression-Pro, Compression 3000, HF 3000, Octiva, Reflex HF	Micro-Ear Technology, Inc.	ESD	Class I	1997-02-11
K964561	Endolumina II Transillumination System 56Fr E-5630, 50Fr E-5030 and 40Fr E-4020, Endolumina II Detachable Tips, 56Fr, Ta	Bioenterics Corp.	FDG	Class I	1997-02-11
K964544	Osteonics Spinal System - Variable Offset Connector Assembly	Osteonics Corp.	MNH	Class II	1997-02-11
K964536	One-Step Dipstick Pregnancy Test	Teco Diagnostics	JHI	Class II	1997-02-11
K964462	One-Step Urine/serum Comno Pregnancy Dipstick Test	Teco Diagnostics	JHI	Class II	1997-02-11
K964461	One -Step Urine/serum Combo Pregnancy Card Test	Teco Diagnostics	JHI	Class II	1997-02-11
K964369	Trach Care Set with Microban	Ballard Medical Products	BSY	Class I	1997-02-11
K964009	Immage Immunochemistry System Gentamicin(gen)/tobramycin(tob) Reagent / Beckman Drug Claibrator 3 Plus	Beckman Instruments, Inc.	DNO	Class II	1997-02-11
K963945	Steri-Oss Gold Attachment System	Steri-Oss, Inc.	DZE	Class II	1997-02-11
K963727	Hoffman H/a Coated Long-Term Ventilation Tube with Liner	Medtronic Xomed, Inc.	ETD	Class II	1997-02-11
K960817	Hd01-Series Transonic Hemodialysis Monitor (R%,qa,co,qb,qb2)	Transonic Systems Inc	MQS	Class II	1997-02-11
K955543	Ultrasound System Model Uf-3500	Fukuda Denshi USA, Inc.	IYO	Class II	1997-02-11
K955183	Safe Knights	L & N Corp.	HIS	Class II	1997-02-11
K945290	8500A Pulse Oximeter	Nonin Medical, Inc	DQA	Class II	1997-02-11
K935706	Epi 2	Universal H.R. System, Inc.	KCX	Class I	1997-02-11
K970260	Seirin Jr Acupuncture Needles	Seirin-America, Inc.	MQX	Class II	1997-02-10
K970254	Seirin Pyonex Acupuncture Needles	Seirin-America, Inc.	MQX	Class II	1997-02-10
K970148	Elecsys Calcheck Estradiol	Boehringer Mannheim Corp.	JJX	Class I	1997-02-10
K970147	Elecsys Calcheck Prolactin	Boehringer Mannheim Corp.	JJY	Class I	1997-02-10
K970054	Tandemrx	Boston Scientific Corporation	GCJ	Class II	1997-02-10
K965213	Stratus Myoglobin Gluorometric Enzyme Immunoassay	Dade Intl., Inc.	DDR	Class II	1997-02-10
K965202	Vacutainer Brand Safety-Lok Blood Collection Set	BD Becton Dickinson Vacutainer Systems Preanalytic	JKA	Class II	1997-02-10
K965026	Pfingst Pressure Paste	Pfingst & Co., Inc.	EFH	Class I	1997-02-10
K964981	Tempfil C&b	Sybron Dental Specialties, Inc.	EBG	Class II	1997-02-10
K964944	Round Dental Bur	Steri-Oss, Inc.	DZE	Class II	1997-02-10
K964931	White Core	Bisco, Inc.	EBF	Class II	1997-02-10
K964862	Troponin-I Test System	Dade Intl., Inc.	MMI	Class II	1997-02-10
K964859	Scimed 5 French Impulse Angiographic Catheters	Scimed Life Systems, Inc.	DQO	Class II	1997-02-10
K964812	Nima Needleless Injectionsite Master Adapter and i.v. Set	Critical Device Corp.	FPA	Class II	1997-02-10
K964810	Dermadam	Ultradent Products Inc.	EFS	Class I	1997-02-10
K964747	Somatom Plus 4 CT Scanner	Siemens Medical Solutions USA, Inc.	JAK	Class II	1997-02-10
K964656	Tefgen Guided Tissue Membrane	American Custom Medical, Inc.	NPK	Class II	1997-02-10
K964647	North American Scientific (Nasi) 1-125 Radionuclide Brachytherapy Source	North American Scientific, Inc.	KXK	Class II	1997-02-10
K964630	Glucometer Elite Blood Glucose Meter	Bayer Corp.	CGA	Class II	1997-02-10
K964629	Vinyl Patient Examination Gloves	Arista Medi Prima	LYZ	Class I	1997-02-10
K964628	Nitrile Powder-Free Examination Gloves	Shen Wei (USA), Inc.	LZA	Class I	1997-02-10
K964626	Edge/vista System Enhancement Package	Philips North America LLC	LNH	Class II	1997-02-10
K964526	Liberty Rectal Pelvic Floor Exerciser	Utah Medical Products, Inc	KPI	Class II	1997-02-10