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 830 of 3530

510(k) clearances, page 830 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K122202	Ellex 2Rt	Ellex Medical Pty Ltd	HQF	Class II	2013-07-01
K131619	Quickvue Influenza A+b	Ortho-Clinical Diagnostics, Inc.	GNX	Class I	2013-06-28
K131568	Sudo Path	LD Technology LLC	GZO	Class II	2013-06-28
K131509	Zoe Fluid Status Monitor	Noninvasive Medical Technologies, Inc.	DSB	Class II	2013-06-28
K130808	Straumann Healing Abutments, Healing Caps, Closure Screws	Straumann USA, LLC	NHA	Class II	2013-06-28
K130724	Codiagnostix Implant Planning Software	Straumann USA, LLC	LLZ	Class II	2013-06-28
K130638	Alluraclarity Xper Fd Series X-Ray System	Philips Medical Systems Nederland B.V.	OWB	Class II	2013-06-28
K130002	Surecall Labor Monitor	Reproductive Research Technologies, LP	OSP	Class II	2013-06-28
K123627	Et Smartfit Abutment	Hiossen, Inc.	NHA	Class II	2013-06-28
K123598	Smith & Nephew, Inc. Hip System Instrumentation	Smith & Nephew, Inc.	JDI	Class II	2013-06-28
K123559	Solusmobile Blood Glucose Managment System	Biotest Medical Corp.	NBW	Class II	2013-06-28
K123427	Nirvana D Personal Lubricant (Tbd)	Church & Dwight Co., Inc.	NUC	Class II	2013-06-28
K123354	Revitive IX	Actegy Ltd.	IPF	Class II	2013-06-28
K123275	IMMUNOCAP ALLERGEN i3, COMMON WASP VENOM (YELLOW JACKET), AND IMMUNOCAP ALLERGEN i4, PAPER WASP VENOM	Phadia AB	DHB	Class II	2013-06-28
K122917	Coda Balloon Catheter	Cook Inc.	DQY	Class II	2013-06-28
K131683	Healix Advance Knotless Peek Anchor (6.5Mm)	DePuy Mitek, Inc.	MBI	Class II	2013-06-27
K131654	Starchmark Breast Tissue Marker; Starchmark Ultracor Breast Tissue Marker	Senorx, Inc.	NEU	Class II	2013-06-27
K131589	Keeler Slit Lamp H-Series	Keeler Ltd.	HJO	Class II	2013-06-27
K131141	Earprobe	Path Medical GmbH	GWJ	Class II	2013-06-27
K131100	Streamline Tl Spinal System	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)	NKB	Class II	2013-06-27
K130790	Lyric2	Phonak, Inc.	ESD	Class I	2013-06-27
K130438	Axle Interspinous Fusion System	Xtant Medical Holdings, Inc.	PEK	Class II	2013-06-27
K130094	Freestyle Precision Pro Blood Glucose and B-Ketone Monitoring System	Abbott Medical	NBW	Class II	2013-06-27
K123404	Bd Phoenix Automated Microbiology System- Imipenem (0.0625-32 Ug/ml)	Becton Dickinson & Co	LON	Class II	2013-06-27
K121920	Laserbrush	Sunetics International Marketing Group, LLC	OAP	Class II	2013-06-27
K131556	Diazyme Lipoprotein (a) Calibrator Set, Control Set	Diazyme Laboratories, Inc.	JIT	Class II	2013-06-26
K130584	Monitor B40	GE Medical Systems China Co., Ltd.	MHX	Class II	2013-06-26
K130549	Intrabeam Flat Applicator, Intrabeam Surface Applicator	Carl Zeiss Meditec Inc	JAD	Class II	2013-06-26
K123288	Hemoconcentrator	MAQUET CARDIOPULMONARY GmbH	KDI	Class II	2013-06-26
K123266	Bd Phoenix Automated Microiology System- Ertapenem 0.0625-8 Ug/ml-Gn	Becton Dickinson & Co	LON	Class II	2013-06-26
K122997	23Ga Curved Illuminating Laser Probe	Peregrine Surgical, LLC.	HQB	Class II	2013-06-26
K122983	Ksea Bipolar Electrode	Karl Storz Endoscopy-America, Inc.	HIN	Class II	2013-06-26
K122653	Mic-Key Sf Low Profile Gastrostomy Tube and Accessories	Kimberly-Clark Corporation	KNT	Class II	2013-06-26
K131489	Tractus Tissuemapper Image Recording System Application	Tractus Corporation	IYO	Class II	2013-06-25
K131373	Shangring	Wuhu Snnda Medical Treatment Appliance Technology Co. Ltd.	HFX	Class II	2013-06-25
K131314	Ddrcruze (Digital Mobile Diagnostic X-Ray System)	SWISSRAY Medical, AG	MQB	Class II	2013-06-25
K131181	Omega Laboratories Hair Drug Screening Assay Phencyclidine	Omega Laboratories, Inc.	LCM	Unclassified	2013-06-25
K131005	Eba2 Femoral Nailing System	Citieffe Inc.	HSB	Class II	2013-06-25
K130850	Primi and Secondi Support Catheters	Thermopeutix, Inc.	DQY	Class II	2013-06-25
K130487	Fastresponder Sternal Intraosseous Device	Pyng Medical Corp.	FMI	Class II	2013-06-25
K130008	Distal Ulna Locking Plate (Dul), Ulna Osteotomy Locking Plate (Uol), 3.0 Cancellous Locking Screw, 3.0 Cortical Locking	I.T.S. GmbH	HRS	Class II	2013-06-25
K122503	Parallax Balloon Inflatable Bone Tamp-10 Mm Balloon Parallax Balloon Inflatable Bone Tamp-15 Mm Balloon Parallax Balloon	Neuro Therm, Inc.	NDN	Class II	2013-06-25
K121628	Epi Mini ECG Portable Health Monitoring System (Epi Mini)	Epi Mobile Health Solutions (S) Pte, Ltd.	DXH	Class II	2013-06-25
K121481	Infini Radiofrequency System	Lutronic Corporation	GEI	Class II	2013-06-25
K131287	Cardiosleeve	Rijuven Corp	DQD	Class II	2013-06-24
K131092	Stealth 360 Orbital Pad System	Cardio Systems, Inc.	MCW	Class II	2013-06-24
K123842	Lawmax Dilator	Lifetech Scientific (Shenzhen) Co,.ltd	DRE	Class II	2013-06-24
K131524	Proteus Patch Including Ingestible Sensor	Proteus Digital Health, Inc.	OZW	Class II	2013-06-23
K131288	Verrata Pressure Guide Wire	Volcano Corporation	DQX	Class II	2013-06-21
K131213	Digital Color Doppler Ultrasound System	Sonoscape Company Limited	IYN	Class II	2013-06-21