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 2026-11-02, 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 1040 of 3531

510(k) clearances, page 1040 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K090953	Total Knee Surgetics Navigation System with Iblock	Praxim Medivision, SA	OLO	Class II	2010-01-21
K093593	Celox Pro, Celox Pro OTC, Celox Hemostatic Granules, Celox Pro Hemostatic Granules, Omni Stat Pro	Medtrade Products Ltd.	QSY	Unclassified	2010-01-20
K093172	Quantitative Electrocardiographic Detector (Qed 1000)	Dynacardia, Inc.	DPS	Class II	2010-01-20
K093065	Finesse Personal Insulin Delivery Patch, Model Fg-2000	Calibra Medical, Inc.	OPP	Class II	2010-01-20
K093022	The Picc Wand Peelable Safety Introducer	Access Scientific, Inc.	DYB	Class II	2010-01-20
K092110	Waveon Fracture Repair System (Waveon Rx)	Sonoma Orthopedic Products, Inc.	HSB	Class II	2010-01-20
K082805	Paguamedicina Structural Hydrogel Pediatric Ureteral Stent, Model Np330-Xxx	Q Urological Corporation	FAD	Class II	2010-01-20
K093923	Cerox Model 3210	Or-Nim Medical, Ltd.	MUD	Class II	2010-01-19
K093849	Accuvix V10 Diagnostic Ultrasound System	Medison Co., Ltd.	IYN	Class II	2010-01-19
K093713	Ultrasound General Purpose Guidance System	CIVCO Medical Instruments Co., Inc.	ITX	Class II	2010-01-19
K093703	3Di	Shina Systems Ltd.	LLZ	Class II	2010-01-19
K093693	Noras or Head Holder S17000-Mq/ Noras or Head Coil 3T 7230-Ph Model S1700-Mq/ 7230-Ph	NORAS MRI products GmbH	MOS	Class II	2010-01-19
K093500	Powder Free Nitrile Examination Gloves, White (Non-Colored) or Blue (Colored), Non-Sterile	Wear Safe (Malaysia) Sdn Bhd	LZC	Class I	2010-01-19
K093445	Keeler Applanation Tonometer; T-Type Kat, K-Type Kat, (Kat)	Keeler Ltd.	HKY	Class II	2010-01-19
K093200	Life Spine Lumbar Plate System	Life Spine	KWQ	Class II	2010-01-19
K092978	Immunocap Rapid Reader, Model 12-3600-10	Phadia AB	DHB	Class II	2010-01-19
K092754	Sbi Foot and Ankle Cannulated Screw System, Model 100-0061	Small Bone Innovations, Inc.	HWC	Class II	2010-01-19
K092655	C. Albicans Pna Fish	Advandx, Inc.	NZS	Class I	2010-01-19
K091936	Blade Anterior Cervical Plate System	Nexxt Medical, Inc.	KWQ	Class II	2010-01-19
K091765	Ebcarryon Blood Glucose Monitoring System	Visgeneer, Inc.	NBW	Class II	2010-01-19
K093970	Pica Catheter	Penumbra Inc.	LIT	Class II	2010-01-15
K093882	Sorin C5 System Model 58-00-00	LivaNova Deutschland GmbH	DTQ	Class II	2010-01-15
K093855	Halo 360 & Sizing Balloon, Model 3441C	Barrx Medical, Incorporated	GEI	Class II	2010-01-15
K093657	Adagio Retracting ECG Lead Wires	Acist Medical Systems, Inc.	DSA	Class II	2010-01-15
K093358	Microplex Coil System-Cosmos, Models 81451Cs-V, 181555Cs-V, 16=81652Cs-V	Terumo Cardiovascular Systems Corporation	HCG	Class II	2010-01-15
K093223	Compumedics Grael System, Models: Grael, Grael ECG	Compumedics Limited	GWQ	Class II	2010-01-15
K092878	Prutect Topical Ointment, Models 45 Gram Tube, 90 Gram Tube	Prugen IP Holdings, Inc.	FRO	Unclassified	2010-01-15
K092743	The Leibinger Advance Internal Midface Distraction System	Stryker Craniomaxillofacial	JEY	Class II	2010-01-15
K091950	Smart-Well Eztest Incubator	Sgm Biotech, Inc.	FRC	Class II	2010-01-15
K091674	Arthrocare Coblator Iq System	ArthroCare Corporation	GEI	Class II	2010-01-15
K091547	Nova Max Plus Blood Glucose and B-Ketone Monitor System, Nova Max Plus B-Ketone Control Solutions, Nova Max Blood Glucos	Nova Biomedical Corporation	NBW	Class II	2010-01-15
K091511	Modern Medical Resectoscope Electrodes	Modern Medical Equipment Mfg., Ltd.	FAS	Class II	2010-01-15
K091259	Ethicon Endo-Surgery Flexible Bipolar Hemostasis Forceps	Ethicon Endo-Surgery Inc	GEI	Class II	2010-01-15
K091052	Piccolo C-Reactive Protein (Crp) Test System	Abaxis Inc	DCN	Class II	2010-01-15
K093730	Port Access Systems Endodirect Arterial Cannula Model Ed24 (Old Code Was-Dfk24)	Edwards Lifesciences LLC	DWF	Class II	2010-01-14
K093659	Eclipse Filter System-Femoral Delivery Kit, Eclipse Filter System-Jugular/subclavian Delivery Kit Model Rf500f Model Rf5	C.R. Bard Inc	DTK	Class II	2010-01-14
K093658	Renu Medical Vasopress Calf , Thigh Garments- All Sizesd, Renu Medical Vasopress Foot Garments	Renu Medical, Inc.	JOW	Class II	2010-01-14
K093519	Medtrade Products Celox Vascular Topical Hemostatic Granules on Sheet	Medtrade Products Ltd.	QSY	Unclassified	2010-01-14
K093518	Ace Surgical Secure Locator 3.25 Implant System	Ace Surgical Supply Co., Inc.	DZE	Class II	2010-01-14
K093308	Mark 5 Nuvo 8 Ocsi, Mark 5 Nuvo 8 Std	Nidek Medical Products Inc	CAW	Class II	2010-01-14
K093231	Albograft Vascular Prosthesis	LeMaitre Vascular Inc.	MAL	Class II	2010-01-14
K092933	Saf (Self Adjusting File)	Redent Nova, Ltd.	EFB	Class I	2010-01-14
K092893	Tytan Automatic Aneroid Sphygmomanometer, Model A730 and Manual Digital Lcd Sphygmomanometer, Model A830 Series	Tytan Medical Corp.	DXN	Class II	2010-01-14
K092831	Disposable Hypodermic Needle	Feel Tech	FMI	Class II	2010-01-14
K092627	Ct2011 Sonicstimu Pain Relief Device	Shenzhen Dongdixin Technology Co., Ltd.	IMG	Class II	2010-01-14
K092158	Reprocessed Electrophysiology Diagnostic Catheters	Sterilmed Inc	NLH	Class II	2010-01-14
K092047	Ascension Metal Great Toe System	Ascension Orthopedics, Inc.	KWD	Class II	2010-01-14
K091867	Advia Centaur Shbg Readypack, Low and High Calibrators and Master Curve Material, Models 06520781, 04819274 and 06520773	Siemens Healthcare Diagnostics Inc.	CDZ	Class I	2010-01-14
K090271	Hydrocoat Mesh	Promethean Surgical Devices, Inc.	FTL	Class II	2010-01-14
K083811	W&h Handpiece Anesto, Model: Ra-5	W & H DentalWerk Buermoos GmbH	EGM	Class II	2010-01-14