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 1173 of 3531

510(k) clearances, page 1173 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K072580	Jet Denture Repair Powder Meharry 100,454 Grams, Jet Denture Repair Professional Package 100 Grams/118ml, 1220,30,23	Lang Dental Mfg Co, Inc.	EBI	Class II	2007-11-05
K072336	Regenerex Porous Titanium Sleeve Augments	Biomet Manufacturing Corp	JWH	Class II	2007-11-05
K072082	Gumease Dental Mouthpiece	Biomedevice, Ltd.	KKO	Class II	2007-11-05
K072019	Akita2 Apixneb	Activaero America, Inc.	CAF	Class II	2007-11-05
K071875	V-Cath Poly Picc	Hdc Corp.	LJS	Class II	2007-11-05
K071768	Erbium Fractional Handpiece	Palomar Medical Products, Inc.	GEX	Class II	2007-11-05
K071692	Theratest El-Ttg Iga/igg and Theratest El-Glia Iga/igg Test Systems	Theratest Laboratories, Inc.	MVM	Class II	2007-11-05
K071610	Mediaid Pulse Oximeter M30 and M34	Mediaid, Inc.	DQA	Class II	2007-11-05
K070270	Piccolight E50,piccolight E56,eurolight E10, Eurolight E30, and Eurolight E36	Kirchner & Wilhelm GmbH + Co.KG	HLJ	Class II	2007-11-05
K062624	Next Generation Laser	Alcon Laboratories	HQF	Class II	2007-11-05
K072919	Vendys, Model 6000 B B/c	Endothelix, Inc.	DQK	Class II	2007-11-02
K072848	Activascrew	Bioretec Ltd.	HWC	Class II	2007-11-02
K072681	Bloodstop Hemostatic Gauze; IX Hemostatic Gauze	Lifescience Plus, Inc.	QSY	Unclassified	2007-11-02
K072532	Truepix Lcd Medical Display Monitor, Models Tx-5M, Tx-3M, Tx-2M	Dooyang Systems, Inc.	LLZ	Class II	2007-11-02
K072313	Amplatzer Torqvue Delivery System	Abbott Medical	DQY	Class II	2007-11-02
K072134	Schick Computed Oral Radiology System	Schick Technologies, Inc.	MUH	Class II	2007-11-02
K071576	Textronics ECG Electrode	Textronics, Inc.	DRX	Class II	2007-11-02
K071051	Fraxel III Sr Laser System and Accessories	Reliant Technologies, Inc.	GEX	Class II	2007-11-02
K070874	Arthro Kinetics Vesalius Mr Generator, Models 2004-2006; Accessories for Mr Generator	Arthro Kinetics, Inc.	HRX	Class II	2007-11-02
K070643	Phoenix Hemodialysis Delivery System, Version 3.35	Gambro, Inc.	KDI	Class II	2007-11-02
K072998	Ideal Software Option for Ge Mr Scanners	GE Healthcare	LNH	Class II	2007-11-01
K072693	Csnp-001A Neuro Package	Toshiba America Medical Systems, In.C	JAK	Class II	2007-11-01
K072641	Digital Electronic Thermometer, Model: Fdth-V0-1 Thru 4.	Famidoc Technology Co., Ltd	FLL	Class II	2007-11-01
K072436	Mega Spine System	BK Meditech Co., Ltd.	MNI	Class II	2007-11-01
K072289	Spinefrontier Dorado Vbr	SPINEFRONTIER, Inc. dba LESspine Innovations	MAX	Class II	2007-11-01
K072215	Titanium Powerport Isp Implanted Port	C.R. Bard Inc	LJT	Class II	2007-11-01
K072059	Gripper Micro Needle	Abbott Medical	FMI	Class II	2007-11-01
K071955	Wim-Pc, Model 1010	Karmelsonix	BZM	Class II	2007-11-01
K071416	Pyramid +4 Anterior Lumbar Spine Plate System	Medtronic Sofamor Danek USA Inc	KWQ	Class II	2007-11-01
K070984	The Precision / Optium Point of Care Blood Glucose Test Strips	Abbott Medical	LFR	Class II	2007-11-01
K070799	Modularis Variostar	Siemens Medical Solutions USA, Inc.	LNS	Class II	2007-11-01
K070669	IOL Injector Set	Medicel AG	KYB	Class I	2007-11-01
K072990	Guardwire Temporary Occlusion and Aspiration System- Carotid	Medtronic, Inc.	NTE	Class II	2007-10-31
K072935	Speeder 1.5T Wrist Array Coil	Quality Electrodynamics	MOS	Class II	2007-10-31
K072909	1.5T 32-Channel Head Coil and 3T 32-Channel Head Coil	Siemens AG Medical Solutions	MOS	Class II	2007-10-31
K072787	Gabriel Blue Tube Magnetically Guided Enteral Feeding Tube, Model Gft-111	Syncro Medical Innovations, Inc.	KNT	Class II	2007-10-31
K072712	Comfort Electric Scooter, Ly-Ew408	Comfort Orthopedic Co., Ltd.	INI	Class II	2007-10-31
K072711	Comfort Powered Wheelchair, Ly-Eb 206	Comfort Orthopedic Co., Ltd.	ITI	Class II	2007-10-31
K072620	Game Ready Classic System, Model 550550	Coolsystems, Inc.	IRP	Class II	2007-10-31
K072569	Metoxit Cam-Blanks	Metoxit AG	EIH	Class II	2007-10-31
K072404	Erbe Erbejet 2 System	Erbe USA Inc	FQH	Class II	2007-10-31
K072358	Bioplex Vasculitis Kit	Bio-Rad Laboratories Inc.	MVJ	Class II	2007-10-31
K072130	PTFE Peel Away Microintroducer	Intromed	DYB	Class II	2007-10-31
K072076	Cytoplast PTFE Suture	Osteogenics Biomedical, Inc.	NBY	Class II	2007-10-31
K071545	Z-800 Volumetric Infusion Pump	Zyno Medical LLC.	FRN	Class II	2007-10-31
K071330	Galtstick Introducer System	Galt Medical Corp	DRE	Class II	2007-10-31
K072931	Mc 3003G-32R Head Coil	Mr Instruments, Inc.	MOS	Class II	2007-10-30
K072567	Symbia-E, Model 10275879	Siemens Medical Solutions USA, Inc.	KPS	Class II	2007-10-30
K072557	Faxitron Specimen Radiography System, Model Mx-20	Faxitron X-Ray Corp.	MWP	Class II	2007-10-30
K072499	Novoflo Catheter Lt	Novosci Corp	MSD	Class II	2007-10-30