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 863 of 3530

510(k) clearances, page 863 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K122821	Celltracks Autoprep System	Veridex, LLC	NQI	Class II	2012-12-13
K122613	Vantage Titan with Helios Gradient Model Mrt-1504/Us	Toshiba America Medical Systems, In.C	LNH	Class II	2012-12-13
K122535	Fujinon/fujifilm Eb-530 Series Bronchoscopes (Eb-530S, Eb-530T and Eb-530H	FUJIFILM Healthcare Americas Corporation	EOQ	Class II	2012-12-13
K122459	Pinnacle Lite Pelvic Floor Repair Kit, Posterior Uphold Lite Vaginal Support System	Boston Scientific Corporation	OTP	Class III	2012-12-13
K122269	Enamic	Vita Zahnfabrik H.Rauter GmbH & Co.	EIH	Class II	2012-12-13
K121853	Ddu-2400/2450 Semiautomatic External Defibrillator and Accessories	Defibtech LLC	MKJ	Class III	2012-12-13
K121398	Charlie Guidewire (Regular), Charlie Guidewire (Stiff)	Guidepath Medical, Inc.	DQX	Class II	2012-12-13
K121218	Hydrasolve Console Sterile Treatment Kit Reusable Cannula, 4Mm Dia, 26 Cm Length, 3 Aperture Reusable Cannula, 4Mm Dia,	Andrew Technologies, LLC	QPB	Class II	2012-12-13
K120936	Abbott Tdm Multiconstituent Calibrator, Thermo Scientific Qms Multi-Constituent Calibrators	Microgenics Corporation	DKB	Class II	2012-12-13
K120844	Medlinx Surgical Mesh	Medlinx Acala Pte, Ltd.	FTL	Class II	2012-12-13
K113771	Signal Gear Urethral Catheter Electrode	Neurovision Medical Products Inc	FAP	Class II	2012-12-13
K123352	S4 Spinal System	Aesculap Inc	NKB	Class II	2012-12-12
K123230	Mosaiq Oncology Information System	Elekta Limited	IYE	Class II	2012-12-12
K123120	Lensx Laser System	Alcon Lensx, Inc.	OOE	Class II	2012-12-12
K122855	Tl 04.1Mm Rn,s, Slactive Tizr 6, 8, 10, 12, 14, 16Mm Dental Implants	Straumann USA, LLC	DZE	Class II	2012-12-12
K122649	Navigator Hd Ureteral Access Sheath Set	Boston Scientific Corporation	FED	Class II	2012-12-12
K122571	Malibu Spinal System with the Daytona Deformity System	Seaspine, Inc.	NKB	Class II	2012-12-12
K122555	Steritec Lead Free Sterilization Process Indicator Tape	Steritec Products Mfg. Co., Inc.	JOJ	Class II	2012-12-12
K122423	Vasu-Picc	Medical Components, Inc.	LJS	Class II	2012-12-12
K122213	Eni-Eye Sh Sphere (Efrofilcon a) Soft (Hydrophilic) Contact Lens for Daily Wear	Soflex Limited	LPL	Class II	2012-12-12
K122000	Hm Surgical Drapes Hm Surgical Equipment Cover	Changzhou Holymed Products Co., Ltd	KKX	Class II	2012-12-12
K121842	Architect Hba1c, Architect Hba1c, and Architect Hba1c	Axis-Shield Diagnostics, Ltd.	LCP	Class II	2012-12-12
K121508	Lightwalker at Lightwalker Dt Lightwalker St-E Lightwalker St-N	Fotona D.D.	PDZ	Class II	2012-12-12
K121152	Surgical Gown, Sms	Jiangsu Guangda Medical Material, Co., Ltd.	FYA	Class II	2012-12-12
K120956	Vsp System	Medical Modeling - a 3D Systems Company	DZJ	Class II	2012-12-12
K112695	Cryotop	Kitazato Biopharma Co., Ltd.	MQK	Class II	2012-12-12
K123479	Progrip Laparoscopic Self-Fixating Mesh	Sofradim Production	FTL	Class II	2012-12-11
K123317	Evis Exera III Gastrointestinal Videoscope Olympus Gixp190n	Olympus Medical Systems Corp.	FDS	Class II	2012-12-11
K123113	L.a.m. Imp Wound Gel	Glycobiosciences, Inc.	FRO	Unclassified	2012-12-11
K122980	Glidesheath Slender Model Rm* Es6j10hqs, Glidesheath Slender Model Rm* Es6f16hq, Glidesheath Slender Model Rm * Rs6j10pq	Terumo Medical Corp.	DYB	Class II	2012-12-11
K122892	Mta2 Root and Pulp Materials	Avalon Biomed, Inc.	KIF	Class II	2012-12-11
K122421	Teethmate Desensitzer Set Teethmate Desensitizer Powder Teethmate Desensitizer Liquid	Kuraray Noritake Dental, Inc.	EJK	Class II	2012-12-11
K122268	Angled Xive Mp Abutment, Angled Ankylos	Dentsply International, Inc.	NHA	Class II	2012-12-11
K122158	Pbp Total Hip System	Pipeline Biomedical Products, LLC	OQG	Class II	2012-12-11
K121843	Np-Cast Abutment System	OSSTEM Implant Co., Ltd.	NHA	Class II	2012-12-11
K121620	Ultrasonic Surgery	Dmetec.Co., Ltd.	DZI	Class II	2012-12-11
K121266	Cardioscope	Pulsecor Limited	DXN	Class II	2012-12-11
K120866	Da01 Blood Glucose Monitoring System	Delbio Incorporation	NBW	Class II	2012-12-11
K120791	Ambient Turboflash 90 Ifs	Arthocare Corporation	GEI	Class II	2012-12-11
K120356	Ncs Fish-Fit Md System Fish-Fit Md Compass Md	NCS Lab SRL	MBI	Class II	2012-12-11
K120237	Bpa-Free Microhybid Composite	Novocol, Inc.	EBF	Class II	2012-12-11
K120146	Quark Series	Cosmed S.r.l.	CBK	Class II	2012-12-11
K113693	Nixall Tm Wound and Skin Care	Seriously Clean Ltd	FRO	Unclassified	2012-12-11
K113394	Mavric Sl	GE Healthcare	LNH	Class II	2012-12-11
K122874	Powdered Nitrile Examination Gloves, Blue and White	Nitrilist Gloves Manufacturing Sdn Bhd	LZA	Class I	2012-12-10
K122835	Powder-Free Vinyl Patient Examination Gloves, Clear(non-Colored)	Yuanhang Plastic Co., Ltd.	LYZ	Class I	2012-12-10
K122828	Powder-Free Vinyl Patient Examination Gloves, Clear(non-Colored)	Shandong Hongxin Chemicals Co., Ltd.	LYZ	Class I	2012-12-10
K122740	Jetprep Flushing Device Ol-103037, Jetprep Flushing Device Ol-133037, Jetprep Flushing Device Ol-168037, Jetprep Flushin	Jetprep, Ltd.	OCX	Class II	2012-12-10
K122489	Emerge Medical Solid Bone Screws	Emerge Medical	HWC	Class II	2012-12-10
K122018	Op300	Palodex Group Oy	OAS	Class II	2012-12-10