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 2026-10-22, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 659 of 3529

510(k) clearances, page 659 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K152578	da Vinci Surgical System, Model IS4000	Intuitive Surgical, Inc.	NAY	Class II	2016-03-30
K143035	Flight 60 Ventilator	Flight Medical Innovations Ltd.	CBK	Class II	2016-03-30
K160621	SIGNAPioneer	GE Healthcare	LNH	Class II	2016-03-29
K160336	Full Automatic (NIBP) Blood Pressure Monitor	Health & Life Corporation	DXN	Class II	2016-03-29
K153767	X-cera Zirconia Blanks	Shenzhen Xiangtong Photoelectricity Technology Co., Ltd.	EIH	Class II	2016-03-29
K153564	Pure Cryogen	Air Liquide Healthcare America	GEX	Class II	2016-03-29
K153284	Synaptive ImageDrive Pro	Synaptive Medical Inc	LLZ	Class II	2016-03-29
K152105	Rocket IPC Insertion Set, Rocket IPC Mini Insertion Set	Rocket Medical	PNG	Class II	2016-03-29
K151252	Puritan Bennett 840 Series Ventilator System	Medtronic, Inc.	CBK	Class II	2016-03-29
K160603	SMV Scientific Schanz Screws	Smv Scientific	HWC	Class II	2016-03-28
K160528	ANATOMIC PEEK PTC Cervical Fusion System	Medtronic Sofamor Danek USA Inc	ODP	Class II	2016-03-28
K160212	ACUVUE (senofilcon C) Soft Contact Lens	Johnson & Johnson Vision Care, Inc.	LPL	Class II	2016-03-28
K153371	Sonicision Cordless Ultrasonic Dissection Device	Medtronic, Inc.	LFL	Unclassified	2016-03-28
K153042	TRYPTIK2C-plate Anterior Cervical Plate System	Spineart SA	KWQ	Class II	2016-03-28
K152640	Infrared Thermometer (FT-F11-BT, FT-F21-BT, FT-31-BT, FT-F41-BT)	Fudakang Industries Co., Ltd.	FLL	Class II	2016-03-28
DEN150058	Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek II, Level 1 and Amplichek II, Level 1 MiniPak, Amplichek II, Level 2 and Amplichek II, Level 2 MiniPak, Amplichek II, Level 3 and Amplichek II, Level 3 MiniPak	Bio-Rad Laboratories Inc.	PMN	Class II	2016-03-28
K160129	MRII Cranial Drill and Accessories	Mri Interventions, Inc.	HBG	Class II	2016-03-26
K160277	LOGIQ F8 Expert, LOGIQ F8, LOGIQ F6	GE Healthcare	IYN	Class II	2016-03-25
K160273	truFreeze System	Csa Medial, Inc.	GEH	Class II	2016-03-25
K160191	Align Anterior Ankle Fusion Plate	Extremity Medical, LLC	HRS	Class II	2016-03-25
K153725	Corin TaperFit Hip Stem	Corin USA	JDI	Class II	2016-03-25
K153721	iTotal Cruciate Retaining (CR) Knee Replacement System	ConforMIS, Inc.	JWH	Class II	2016-03-25
K153595	Optetrak Logic Metaphyseal Cones	Exactech, Inc.	JWH	Class II	2016-03-25
K153441	VibraPEP	Medica Holdings, LLC	BWF	Class II	2016-03-25
K153337	Corvocet Biopsy System	Merit Medical Systems, Inc.	KNW	Class II	2016-03-25
K152978	DeRoyal Angiography Kits	DeRoyal Industries, Inc.	DXT	Class II	2016-03-25
K152808	U&U Insulin Syringe with/without Safety Retractable Device	U&u Medical Technology Co., Ltd	MEG	Class II	2016-03-25
K152470	Great Basin Staph ID/R Blood Culture Panel	Great Basin Scientific, Inc.	PAM	Class II	2016-03-25
K152274	Mscb-001	GC America Inc.	EIH	Class II	2016-03-25
K152200	SurgTech Interbody System	Surgtech, Inc.	MAX	Class II	2016-03-25
K151943	Vas-Q-Clip	Nanova Biomaterials Inc	FZP	Class II	2016-03-25
K151923	VITEK 2 AST-Yeast Micafungin (0.06-8 mcg/mL)	bioMerieux, Inc.	NGZ	Class II	2016-03-25
K151799	EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA Thyroid Positive Control 2500/5000	Phadia AB	JZO	Class II	2016-03-25
K151765	SOMATOM Perspective	Siemens Medical Solutions USA, Inc.	JAK	Class II	2016-03-25
K160547	Cascadia Interbody System	K2M, Inc	MAX	Class II	2016-03-24
K153782	NuVasive® Lumbar Interbody Implants	Nu Vasive, Incorporated	MAX	Class II	2016-03-24
K153667	TRUESPAN Meniscal Repair System	Medos International SARL	MBI	Class II	2016-03-24
K153392	STERIZONE VP4 Sterilizer	Ts03, Inc.	PJJ	Class II	2016-03-24
K153226	Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit	ZOLL Circulation, Inc.	NCX	Class II	2016-03-24
K153202	iMESH Tacker	Thd Lap	GDW	Class II	2016-03-24
K152716	EV Insite System	Psp Corporation	LLZ	Class II	2016-03-24
K152253	Biomet Microfixation RibFix Blu Thoracic Fixation System	Biomet Microfixation	HRS	Class II	2016-03-24
K151881	X-Fix Line Additions	Vilex LLC	KTT	Class II	2016-03-24
K151778	Cardinal HealthTM Sterile Latex Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating	Medtronic, Inc.	KGO	Class I	2016-03-24
K151461	Hybernite RT	Plastiflex Group NV	BZE	Class II	2016-03-24
K151342	Arthrex SwiveLock Anchors	Arthrex GmbH	MAI	Class II	2016-03-24
K150702	Exceed Tx	Great Lakes Orthodontics, Ltd.	DYW	Class II	2016-03-24
K160479	PointerShell Universal, PointerShell LS	Fiagon GmbH	PGW	Class II	2016-03-23
K160466	Response 5.5 Spine System	Orthopediatrics Corp	NKB	Class II	2016-03-23
K160259	ZELTIQ CoolSculpting System	Zeltiq Aesthetics Inc	OOK	Class II	2016-03-23