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 868 of 3530

510(k) clearances, page 868 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K122860	Kls Martin Recon Talon	KLS-Martin L.P.	HRS	Class II	2012-11-14
K123214	Encore 26 Advantage Kit	Boston Scientific Corporation	MAV	Class II	2012-11-13
K123068	Optima Mr 430S	GE Healthcare	LNH	Class II	2012-11-13
K123056	Pascal Laser Indirect Ophthalmoscope	Topcon Medical Laser Systems, Inc. (Tmls)	HQF	Class II	2012-11-13
K122662	Vertiflex Direct Decompression System	Vertiflex, Inc.	HRX	Class II	2012-11-13
K122324	Vpap S-a	ResMed Corp	MNS	Class II	2012-11-13
K122180	High Flow Insufflantion Unit	Olympus Medical Systems Corp.	HIF	Class II	2012-11-13
K120857	Epi-Sense Guided Coagulation Device with Visitrax	Ncontact Surgical, Inc.	OCL	Class II	2012-11-13
K112830	Zoefluid Status Monitor (Model Zoe 2B)	Noninvasive Medical Technologies, Inc.	DSB	Class II	2012-11-13
K122765	Persona Natural Tibia Baseplates	Zimmer GmbH	JWH	Class II	2012-11-09
K122580	Aem Disposable Suction Irrigation Handset Model Es1700; Aem Disposable Suction Irrigation Electrodes Model Es077x Series	Encision, Inc.	GEI	Class II	2012-11-09
K122405	Air-Band Radial Compression Device	Datascope Corp., Cardiac Assist Division	DXC	Class II	2012-11-09
K122122	Regen Spray Applicator,	REGEN LAB SA	FMF	Class II	2012-11-09
K121891	Newport Aura Ventilator	Newport Medical Instruments, Inc.	CBK	Class II	2012-11-09
K121599	Crit-Line Clip (Clic)	Fresenius Medical Care Renal Therapies Group, LLC	KOC	Class II	2012-11-09
K121356	Micro/mini N-Pk(h) Bone Anchor	Anulex Technologies, Inc.	MBI	Class II	2012-11-09
K121354	Micro/mini N-Pk(f) Bone Anchor	Anulex Technologies, Inc.	MBI	Class II	2012-11-09
K120888	Psg-1100 Sleep Diagnostic System	Nihon Kohden Corp.	GWQ	Class II	2012-11-09
K113314	Precichek Ns-101 Poct Professional Blood Glucose Monitoring System	HMD Biomedical, Inc.	LFR	Class II	2012-11-09
K113124	Aln Optional Vana Cava Filter	Aln Implants Chirurgicaux	DTK	Class II	2012-11-09
K112853	Voltera Powered Suction Pump	Suzric Enterprise Co., Ltd.	OMP	Class II	2012-11-09
K112091	H-Max S Femoral Stems, Modular Femoral Heads, Cemented Cups, Lock Bipolar Heads	Lima Corporate S.p.A.	MEH	Class II	2012-11-09
K122795	Stingray Guidewires	Boston Scientific Corporation	DQX	Class II	2012-11-08
K121607	Terumo(r) Needle	Terumo (Philippines) Corporation	FMI	Class II	2012-11-08
K120873	Zimmer Zfx Abutment for Nobel Replace Implant System	ZimVie US Corp LLC	NHA	Class II	2012-11-08
K120479	Mtf Fascia	Musculoskeletal Transplant Foundation d/b/a/ MTF Biologics	OWY	Class II	2012-11-08
K113601	Aap Loqteq Distal Medial Tibia Plate 3.5 System	AAP Implantate AG	HRS	Class II	2012-11-08
K113316	Dcs Lacrimal Stent	Dcs Surgical, Inc.	OKS	Unclassified	2012-11-08
K113066	Corvis St	Oculus Optikgerate GmbH	HKX	Class II	2012-11-08
K123268	Smartstitch Perfectpasser System	Arthocare Corporation	GAT	Class II	2012-11-07
K122959	Hammer Toe Implant	Trilliant Surgical LLC	HWC	Class II	2012-11-07
K122912	Digital Thermometer (with Disposable Thermometer Cover)	Hangzhou Hua'an Medical & Health Instruments Co.	FLL	Class II	2012-11-07
K122857	Hope Continuous Nebulizer Model Hope-11310, Heart Nebulizer Model Heart-100609, Theramist Nebulizer Model Theramist-3100	Pegasus Research Corp.	CAF	Class II	2012-11-07
K122738	Gaitway Implant System, Surgical Instrument Set	Solana Surgical, LLC	HWC	Class II	2012-11-07
K122689	Inoblender	Mallinckrodt Manufacturing LLC	MRO	Class II	2012-11-07
K122380	Ocelot System	Avinger, Inc.	PDU	Class II	2012-11-07
K122278	Baylis Medical Company Radiofrequency Perforation Generator	Baylis Medical Co., Inc.	GEI	Class II	2012-11-07
K121814	Encore Tongue Suspension System	Siesta Medical, Inc.	ORY	Class II	2012-11-07
K121771	Zimmer Persona the Personalized Knee System	Zimmer GmbH	MBH	Class II	2012-11-07
K121725	Pioneer Posterior Occipito-Cervico-Thoracic (Oct) System	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)	KWP	Class II	2012-11-07
K121277	Z-Snap Off Screw, Z-Double Thread Compression Screw, Z-Guide Wire, Z-Staple	Z-Medical GmbH & Co. KG	HWC	Class II	2012-11-07
K120508	Clearlumen Thrombectomy System	Walk Vascular, LLC	QEZ	Class II	2012-11-07
K112877	Comen Multi-Parameter Patient Monitor	Goldway (Us), Inc.	MWI	Class II	2012-11-07
K122998	Blue Powdered Nitrile Examination Glove	Northstar Healthcare Holdings	LZA	Class I	2012-11-06
K122187	Vreselect Culture Medium	Bio-Rad	JSO	Class II	2012-11-06
K120659	Hu-Friedy Dental Cartridge Syringe	HU-Friedy Mfg. Co. LLC	EJI	Class II	2012-11-06
K120560	Trinity Wrinkle Remover	Carol Cole Company	OHS	Class II	2012-11-06
K120466	Verigene Cyp2c19 Nucleic Acid Tes (2C19)	Luminex Corporation	NTI	Class II	2012-11-06
K113225	Nylus Picc	Semprus Biosciences	LJS	Class II	2012-11-06
K112599	Insurgical Single Use Power Equipment	Insurgical, Inc.	KIJ	Class I	2012-11-06