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 970 of 3531

510(k) clearances, page 970 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K103829	Kneealign System	OrthAlign, Inc.	OLO	Class II	2011-04-04
K103617	Digital Forehead Thermometer	K-Jump Health Co., Ltd.	FLL	Class II	2011-04-04
K103428	The Artas System from Restoration Robotics	Venus Concept Inc.	ONA	Class II	2011-04-04
K103369	Vault Alif System	Spinal USA	OVD	Class II	2011-04-04
K103366	Rt600	Restorative Therapies Inc.	GZI	Class II	2011-04-04
K102990	Brainlab Knee	Brainlab, Inc.	OLO	Class II	2011-04-04
K102726	Cardiohelp System	MAQUET CARDIOPULMONARY GmbH	DTQ	Class II	2011-04-04
K101088	Easyra Albumin, Calcium, Magnesium and Inorganic Phosphorous Reagent	Medica Corp.	CIX	Class II	2011-04-04
K110820	Ventralight (Tm) St Mesh with Echo Ps (Tm) Positioning System	C.R. Bard Inc	FTL	Class II	2011-04-01
K110727	Hylatopicplus Cream	Precision Dermatology Incorporated	FRO	Unclassified	2011-04-01
K110708	Equinoxe Reverse Shoulder Compression Screw / 38Mm and 42Mm Glenosphere / Superior Augment Glenoid Plate, 10 Degrees...	Exactech, Inc.	PHX	Class II	2011-04-01
K110610	1.5 Ge 6-Channel Phased Array Flex Coil, 3.0 Ge 6-Channel Phased Array Flex Coil	GE Healthcare	MOS	Class II	2011-04-01
K110542	Consensus Biolox Delta Ceramic Femoral Head	Consensus Orthopedics, Inc.	LPH	Class II	2011-04-01
K110522	Vertex Reconstruction System, Vertex Select Reconstruction System	Medtronic Sofamor Danek USA Inc	KWP	Class II	2011-04-01
K110216	Expedium System, Viper System	DePuy Spine, Inc.	NKB	Class II	2011-04-01
K103595	Acclarent Tympanostomy Tube and Tympanostomy Tube Delivery System	Acclarent Inc	ETD	Class II	2011-04-01
K103219	Sterrad Sealsure Chemical Indicator Tape	Advanced Sterilization Products	JOJ	Class II	2011-04-01
K103218	Sterrad Chemical Indicator Strip	Advanced Sterilization Products	JOJ	Class II	2011-04-01
K102948	Torflex Transseptal Guiding Sheath	Baylis Medical Co., Inc.	DYB	Class II	2011-04-01
K102699	Architect Igentamicin Reagents; Architect Igentamicin Calibrators	Abbott Medical	LCD	Class II	2011-04-01
K101722	Alyte Y-Mesh Graft	C.R. Bard Inc	OTO	Class II	2011-04-01
K101484	Compressyn Band	Dallen Medical, Inc.	JDQ	Class II	2011-04-01
K100724	Osseotite II Model Xifossxxx	ZimVie US Corp LLC	DZE	Class II	2011-04-01
K100714	Csmc Cardiac Suite-Nuclear Medicine Software Applicaton Model 2010-01	Cedars Sinai Medical Center	KPS	Class II	2011-04-01
K110796	Simpliclear Rectangular Orthodontic Wire	Biomers Products, LLC	DYW	Class II	2011-03-31
K110660	Arthrex Biocomposite Suturetak	Arthrex GmbH	MAI	Class II	2011-03-31
K110622	Intellivue Patient Monitor	Philips Medizinsysteme Boeblingen GmbH, Cardiac an	MHX	Class II	2011-03-31
K110218	Inspira Air Balloon Dilation System	Acclarent Inc	KTI	Class II	2011-03-31
K110058	Bpa-Free Pit and Fissure Sealant	Novocol Inc. dba Septodont and Confi-Dental Produc	EBC	Class II	2011-03-31
K103670	Nitrile Examination Gloves Polymer Coated (White, Blue, and Black Color)	Innovative Gloves Co;, Ltd.	LZA	Class I	2011-03-31
K103499	A Scope	Active Signal Technologies, Inc.	DQD	Class II	2011-03-31
K103498	Lakong Ultrasonic Scaler	Lakong Medical Device Company, Ltd.	ELC	Class II	2011-03-31
K103339	Tds Abutment for Friadent Xive	Pou YU Biotechnology Co., Ltd.	NHA	Class II	2011-03-31
K101830	Zmachine, Model Dt-100	Consolidated Research of Richmond, Inc.	OLV	Class II	2011-03-31
K101482	Em-9000	Elite Medical, LLC	LNS	Class II	2011-03-31
DEN100025	Widexlink in Clear Series Hearing Aids	Office Research in Clinical Amplifiction	OSM	Class II	2011-03-31
DEN070014	Mandometer III	AB Mando	OBV	Class II	2011-03-31
K110721	Gaunying Infrared Lamp	Foshan Gaunying Electronics Co., Ltd	ILY	Class II	2011-03-30
K110038	Truclear Morcellator System	Smith & Nephew, Inc.	HIH	Class II	2011-03-30
K103586	Ios Fastscan Spray	Ios Technnologies, Inc.	ELW	Class II	2011-03-30
K103410	Neopap System	Childrens Medical Ventures, LLC	BZD	Class II	2011-03-30
K103106	Chlorashield Tm Antimicrobial Dressing	Care Fusion 213, LLC	FRO	Unclassified	2011-03-30
K102936	Homechoice/homechoice Pro Automated Personal Cycler Peritoneal Dialysis System Model 5C4471, 5C8310, 5C4471r and 5C8310r	Baxter Healthcare Corporation	FKX	Class II	2011-03-30
K102402	Solus Anterior Lumbar Interbody Fusion (Alif) Spinal Spacer System	Alphatec Spine, Inc.	OVD	Class II	2011-03-30
K102115	Odfs Pace	Odstock Medical Ltd	GZI	Class II	2011-03-30
K110685	Flexiva Tractip	Boston Scientific Corporation	GEX	Class II	2011-03-29
K110591	Mc 1504G-16R, 1.5T, 16-Channel, Mc 3004G-16R, 3.0T, 16-Channel Head Coil	Mr Instruments, Inc.	MOS	Class II	2011-03-29
K103828	Bili-Therapy Spot Type	Atom Medical Corporation	LBI	Class II	2011-03-29
K103596	Wireless/wired Fdr D-Evo Flat Panel Detector	FUJIFILM Healthcare Americas Corporation	MQB	Class II	2011-03-29
K103591	Digital Radiography	Canon Inc. -Medical Equipment Group	MQB	Class II	2011-03-29