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 2219 of 3531

510(k) clearances, page 2219 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K932809	Frangi-Cath Safe-Release(tm) Connector	Excalibur Engineering Care of Rms, Inc.	EZL	Class II	1994-03-17
K932118	Endoscopic Transmural Suture Needle Set	Core Dynamics, Inc.	HET	Class II	1994-03-17
K925566	Holmes Air Purifier Models Hap-240 & Hap-300	Holmes Products Corp.	FRF	Class II	1994-03-17
K922621	Ha Ti-Fit Acetabular and Femoral Component	Smith & Nephew Richards, Inc.	MEH	Class II	1994-03-17
K940696	Syncra Tilt Option for Angio Diagnost 5	Philips North America LLC	KXJ	Class II	1994-03-16
K940687	Trocar	Phx Technologies Corp.	GCJ	Class II	1994-03-16
K940539	Stand Imaging Dose Calibrator Shielded Work Platform	Standard Imaging Inc.	KPY	Class I	1994-03-16
K940294	Shimadzu Mobile X-Ray Systems	Shimadzu Precision Instruments, Inc.	OXO	Class II	1994-03-16
K936180	Tc+ System (Tilting C-Arm System)	GE Healthcare	OWB	Class II	1994-03-16
K935664	Fast Spin Echo	FUJIFILM Healthcare Americas Corporation	LNH	Class II	1994-03-16
K935661	Magnetom Open	Siemens Medical Solutions USA, Inc.	LNH	Class II	1994-03-16
K935580	Phf20 20 Mobile C-Arm Image Intensifier	Precise Optics	OXO	Class II	1994-03-16
K935570	Noise Filter for Paradigm Magnetic Resonance Imaging System	Resonex, Inc.	LNH	Class II	1994-03-16
K935304	3M Dental Electronic Anesthesia (Dea) System 8670	3M Company	LWM	Unclassified	1994-03-16
K934738	Autosuture Endoscopic Suturing Device	United States Surgical, A Division of Tyco Healthc	OCW	Class II	1994-03-16
K934700	Model 90P Portable Medical Diagnostic X-Ray	Tempo Technology, Inc.	OXO	Class II	1994-03-16
K934688	Sterile Design	Sterile Design, Inc.	LRO	Class II	1994-03-16
K934483	Nu-Vois Battery Powered Artificial Larynx	Mountain Precision Mfg. Ltd. Co.	ESE	Class I	1994-03-16
K933776	Optik Laparoscope	Optik	GCJ	Class II	1994-03-16
K933595	Bur, Surgical, General & Plastic Surgery	Omega Surgical Instruments, Inc.	GFA	Class I	1994-03-16
K933558	Arm Radiation Beam Scanner	Advanced Radiation Measurements, Inc.	IYE	Class II	1994-03-16
K932863	E-Fax Remote Monitor	Coherent Systems, Inc.	DXH	Class II	1994-03-16
K932564	Radstat	Dimensional Medicine, Inc.	LLZ	Class II	1994-03-16
K931393	Bebig Plaques Rum101-Rum114	Bebig, Inc.	KXK	Class II	1994-03-16
K922315	Vital-Combo(r)	Physio Control, Inc.	LDD	Class II	1994-03-16
K940680	Versadowel Post System	Dental Power, Inc.	ELR	Class I	1994-03-15
K940143	Glycated Hemoglobin Controls	Trinity Biotech (Primus Corporation dba Trinity Biotech)	LCP	Class II	1994-03-15
K936222	Dentin Conditioning and Adhesive System	Jeneric/Pentron, Inc.	KLE	Class II	1994-03-15
K936032	Torque Device	Merit Medical Systems, Inc.	DQX	Class II	1994-03-15
K935274	Diprivan Luer Connector	GE Healthcare	LHI	Class II	1994-03-15
K935057	Factor VIII Deficient Plasma	Sigma Diagnostics, Inc.	GJT	Class II	1994-03-15
K934091	Oxisat	Marquette Electronics, Inc.	DQA	Class II	1994-03-15
K933402	Turbo II	KCI USA, Inc.	FNM	Class II	1994-03-15
K933224	Slimflex - Powder Free Latex Examination Gloves	Slim River Latex Sdn. Bhd.	LYY	Class I	1994-03-15
K932898	Powered Muscle Stimulator	Nemectron GmbH	IPF	Class II	1994-03-15
K932332	Patient Examination Glove - Powdered	Sj Medical Products (M) Sdn Bhd	LYY	Class I	1994-03-15
K932266	Symbiosis Dispos Gastro Biopsy Forceps W/reuse Han	Boston Scientific Corporation	KGE	Class II	1994-03-15
K932116	Patient Examination Gloves (Powder Free)	Evergrade Healthcare Products Sdn Bhd	LYY	Class I	1994-03-15
K931762	Candela Sptl Pulsed Dye Lasers	Candela Corporation	GEX	Class II	1994-03-15
K931205	Medi Vac Specimen Collector and Transporter	Baxter Healthcare Corporation	HHI	Class II	1994-03-15
K930808	Protector Introducer Sheath	Boston Scientific /International Technologies	DYB	Class II	1994-03-15
K930768	Orion Diagnostic Ultrasound System	GE Healthcare	IYO	Class II	1994-03-15
K930656	Sullivan III Nasal CPAP System	Rescare, Ltd.	BZD	Class II	1994-03-15
K924436	Bard Urotrack II Monitoring	C.R. Bard Inc	KOC	Class II	1994-03-15
K940684	Surgical Instrument, Disposable	Her-Mar, Inc.	MDM	Class I	1994-03-14
K940463	Nonin Medical, Inc. Finger Phantom for Pulse Oximeters	Nonin Medical, Inc	DQA	Class II	1994-03-14
K940286	Gamma Locking Nail Modification	Howmedica Corp.	KTT	Class II	1994-03-14
K936028	Cedia(r) Dau Bar/benz 300,300 Intermed & High Calib	Microgenics Corporation	DKB	Class II	1994-03-14
K936027	Sports Radio Sunglasses	Vast Lea Enterprise Co., Ltd.	HQY	Class I	1994-03-14
K935814	Microvasive(r)/meditech(r) Asap(tm) 14G Biopsy Needle	Boston Scientific Corporation	KNW	Class II	1994-03-14