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 952 of 3531

510(k) clearances, page 952 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K101114	Advancis Activon Tube	Advancis Medical	FRO	Unclassified	2011-07-26
K111555	Circumaural Adhesive Replacement	R & D Medical Products, Inc.	GWJ	Class II	2011-07-25
K111263	Cxi Triforce	Cook Incorporated	KRA	Class II	2011-07-25
K111213	Vision One Laser System	Lumenis Ltd	GEX	Class II	2011-07-25
K110990	Gso Acp1 Anterior Cervical Plate System	Gold Standard Orthopedics, LLC	KWQ	Class II	2011-07-25
K110592	3.7Mm/5.0mm Dynamic Locking Screw	Synthes (USA) Products LLC	HWC	Class II	2011-07-25
K103285	Dixtal Dz-4100 Series Pulse Oximeter	Dixtal Medical, Inc.	DQA	Class II	2011-07-25
K111866	Nuvasive Anterior Lumbar Plate System	NuVasive Inc	KWQ	Class II	2011-07-22
K111631	Gil Anchor / Gil Quick Anchor Plus, Healix Ti Dual Threaded Suture Anchor, Rotator Cuff Anchor / Rotator Cuff Quick an..	DePuy Mitek, Inc.	MBI	Class II	2011-07-22
K111524	Mp 719	Marine Polymer Technologies, Inc.	MTJ	Unclassified	2011-07-22
K111348	Re / Stasis (Tm) Gingival Retraction Paste	Centrix, Inc.	MVL	Unclassified	2011-07-22
K111302	Mylabseven, Mylabalpha	Esaote S.p.A.	IYN	Class II	2011-07-22
K111152	Rotograph Evo 3D	Villa Sistemi Medicali S.p.A.	MUH	Class II	2011-07-22
K111110	Apnea Guard	Advanced Brain Monitoring, Inc.	LRK	Class II	2011-07-22
K111009	Acrylic Herbst Appliance	Embassy Dental Laboratory	LRK	Class II	2011-07-22
K110987	Cardiac Trigger Monitor	Ivy Biomedical Systems, Inc.	DRT	Class II	2011-07-22
K110984	Slim E30 II CO2 Laser	Lasering S.r.l.	ONG	Class II	2011-07-22
K110943	Logiq E9	GE Healthcare	IYN	Class II	2011-07-22
K110915	Cervical Cage	Eisertech, LLC	ODP	Class II	2011-07-22
K110529	Endoflip Gastric Tube	Crospon, Ltd.	KNT	Class II	2011-07-22
K110271	Maestro Wrist Plating System	Biomet Manufacturing Corp	HRS	Class II	2011-07-22
K103414	Venus Cervical Spinal Fixation System	L&K Biomed Co.,Ltd.	MNI	Class II	2011-07-22
K102674	Cuff Sentry	Salter Labs	BSK	Class II	2011-07-22
K111801	Simmetry(tm) Sacroiliac Joint Fusion System	Zyga Technology, Inc.	OUR	Class II	2011-07-21
K111750	Extra Pta Balloon Catheter with Embolic Capture Feature; Proteus Pta Balloon Catheter with Embolic Capture Feature	Angioslide, Ltd.	DQY	Class II	2011-07-21
K111552	Elecsys T3 Calcheck 5	Roche Diagnostics GmbH	JJX	Class I	2011-07-21
K111536	Metasurg Digifuse Implant	Metasurg	HWC	Class II	2011-07-21
K111362	Rexious Spinal Fixation System	Dio Medical Co., Ltd.	MNH	Class II	2011-07-21
K111280	V.a.c. 125 Negative Pressure Wound Therapy Unit	KCI USA, Inc.	OMP	Class II	2011-07-21
K111006	Ci-Snap Wound Care System	Spiracur, Inc.	OKO	Class II	2011-07-21
K110970	Powdered Vinyl Patient Examination Gloves, Clear (Non-Colored)	Ppp Medical and Safety Products Company Limited	LYZ	Class I	2011-07-21
K110966	Powdered Vinyl Patient Examination Gloves, Light Yellow Color (Non-Colored)	Ppp Medical and Safety Products Company Limited	LYZ	Class I	2011-07-21
K110320	Comprehensiveproximal Humeral Plating System	Biomet Manufacturing Corp	HRS	Class II	2011-07-21
K110201	Explor Radial Head Plating System	Zimmer GmbH	HRS	Class II	2011-07-21
K103831	Depuy Mitek Milagro Interference Screw Model 231803, 231804, 231807, 231809	DePuy Mitek, Inc.	MAI	Class II	2011-07-21
K103671	Genesys Spine Tilock System	Genesys Spine	NKB	Class II	2011-07-21
K103631	Sleepminder Breathing Frequency Indicator	Biancamed Limited	BZQ	Class II	2011-07-21
K103431	Coren Total Hip System	Corentec Co., Ltd.	LPH	Class II	2011-07-21
K102405	Infusion Set for Powerpicc Solo 2 Catheter	C.R. Bard Inc	FPA	Class II	2011-07-21
K101886	Dsc/alf Spinal System	Sintea Plastek, LLC	MQP	Class II	2011-07-21
K101453	Vitala Natural Resorbable Collagen Membrane	Obi Biologics, Inc.	NPL	Class II	2011-07-21
K100305	Eturn Spinal Implant Model Eturn Xx-12; Eturn Xx-16 Where Xx=07, 09, 11, 13, or 15 and Eturn Xx-12 K; Eturn Xx-16 K Wher	Icotec AG	MAX	Class II	2011-07-21
K111774	Pathway Model 07Xxxx	Custom Spine, Inc.	MAX	Class II	2011-07-20
K111598	Powder-Free Non-Sterile Vinyl Examination Glove	Lpl (Hui Zhou) Glove	LYZ	Class I	2011-07-20
K111399	Speedfix Suture Implant, 3.0Mm Drill, Pathfinder Obturator, Sharp Tipped Obtrurator, Low Profile Drill Guide Model Om-75	ArthroCare Corporation	MBI	Class II	2011-07-20
K111316	Aap Cannulated Screws	AAP Implantate AG	HWC	Class II	2011-07-20
K111299	Axxent Radiation Shield - Rigid	Xoft, an Icad Company	JAD	Class II	2011-07-20
K111291	Aidite Zirconia Dental Ceramics	Qinhuangdao Aidite High-Technical Ceramics Co, Ltd.	EIH	Class II	2011-07-20
K111205	Microscan (R) Microstrep Plus (R) Panels	Siemens Healthcare Diagnostics Inc.	LRG	Class II	2011-07-20
K111061	Reverse Shoulder Monoblock Prosthesis (Rsp)	Encore Medical, LP	PHX	Class II	2011-07-20