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 2026-10-26, 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 2751 of 3530

510(k) clearances, page 2751 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K875309	Sanitary Menstrual Napkin	Universal Health Care Products Canada, Inc.	HHD	Class I	1988-03-14
K875277	Additional Indications for Xomed Audiant Bone Con.	Xomed, Inc.	LXB	Class II	1988-03-14
K875007	Prisma Dispos. Brite Lite Fiberoptic Endoillumina.	Advanced Surgical Products, Inc.	FST	Class II	1988-03-14
K875006	Prisma Disposa. Brite Lite Fiberoptic Endo. W/pick	Advanced Surgical Products, Inc.	FST	Class II	1988-03-14
K875005	Prisma Dispos. Brite Lite Fiberoptic Endoillumina.	Advanced Surgical Products, Inc.	FST	Class II	1988-03-14
K875004	Prisma Dispos. Brite Lite Fiberoptic Endo. W/pick	Advanced Surgical Products, Inc.	FST	Class II	1988-03-14
K874837	Ktp/532 Laser for Ob-Gyn Use	Laserscope	HHR	Class II	1988-03-14
K873255	The Micro-Vent/ha	Core-Vent Corp.	DZE	Class II	1988-03-14
K880813	Self-Retaining Soft Tissue Retractor	T. Korossurgical Instruments Corp.	GAD	Class I	1988-03-11
K880812	Spinal Needle	T. Korossurgical Instruments Corp.	GDM	Class I	1988-03-11
K880785	Skilcraft	Pennsylvania Association for the Blind	KDD	Class I	1988-03-11
K880757	Tecnol Fluid Shield Surgical Mask W/eyeguard	Tecnol New Jersey Wound Care, Inc.	FXX	Class II	1988-03-11
K880603	Coherent Xa-40 CO2 Surgical Laser	Coherent Medical Group	GEX	Class II	1988-03-11
K880513	Disp. Non-Magnetic Surgical Instru. Drape	Taub Industries	KKX	Class II	1988-03-11
K880253	Blakemore Retainer	Mizuho Orthopedic Systems Inc	FEF	Class II	1988-03-11
K880206	Polyderm Wbc (Tm), Waterproof Breathable Cover	Laivan Corp.	NAD	Class I	1988-03-11
K880172	Model 4900 Nd:yag Laser for Neurosurgery Applica.	Cooper Lasersonics, Inc.	LKW	Class III	1988-03-11
K880073	Yesng Model 500Sii Electrosurgical Unit	Ferguson Medical	GEI	Class II	1988-03-11
K880064	Yesng Model 200S11 Electrosurgical Unit	Ferguson Medical	GEI	Class II	1988-03-11
K880009	Revised Labeling for Adx Cocaine Metabolite	Abbott Medical	DIO	Class II	1988-03-11
K880003	Additional Allergens for Ige Fast-Plus Test	Em Diagnostic Systems, Inc.	DHB	Class II	1988-03-11
K875008	Guardall Shield	Anago, Inc.	FXX	Class II	1988-03-11
K874693	Obt Stereotactic System	Tipal Instruments, Ltd.	HAW	Class II	1988-03-11
K874631	Healthphone Toco Model	Carelink	HFM	Class II	1988-03-11
K874554	Enviclusive (Tm)	Marion Laboratories, Inc.	NAD	Class I	1988-03-11
K874195	La Antibody Test Kit	Lipogen, Inc.	LJM	Class II	1988-03-11
K874152	Rnp Antibody Test Kit	Lipogen, Inc.	LKO	Class II	1988-03-11
K873150	Pds, Model Nst 40 Fetal Monitor, Recorder & Trans.	Pediatric Diagnostic Service	HFM	Class II	1988-03-11
K875313	Porcelain Veneer Resin Cement W/dual Cure Catalyst	Bisco, Inc.	EBF	Class II	1988-03-10
K875238	Siemens Neuroton 826 and 827	Elmed, Inc.	IPF	Class II	1988-03-10
K875076	Florida Probe	Florida Probe Corp.	EIX	Class I	1988-03-10
K874635	Omnifit Total Knee Bone Augmentation Wedges	Osteonics Corp.	JWH	Class II	1988-03-10
K880683	King Systems, Disp. Anesthesia Breathing Circuit	King Systems Corporation.	CAI	Class I	1988-03-09
K880664	Mortara Instrument Model Eli-Xr (Treadmill Included)	Mortara Instrument, Inc.	DSI	Class II	1988-03-09
K880635	In the Ear Hearing Aid	Tallahassee Hearing Aid Center	ESD	Class I	1988-03-09
K880614	Shiley Disp. Cannula Cuffless Traceostomy Tube	Shiley, Inc.	BTO	Class II	1988-03-09
K880518	Mobile C-Arm Omni 325	Fischer Imaging Corp.	OXO	Class II	1988-03-09
K880283	Paceart Pacemaker Patient Test Syst/tel Opt Cpts	Paceart, Inc.	DXH	Class II	1988-03-09
K880225	Magic Ear Model Ci in-the-Ear Hearing Aid	Audiotone, Inc.	ESD	Class I	1988-03-09
K880184	Vibrasound in-the-Ear Hearing Aid	Vibrasound Research Corp.	ESD	Class I	1988-03-09
K880179	Beavers' Dental Diamond Instruments	Beavers Dental, Div. Sybron Canada, Ltd.	DZP	Class I	1988-03-09
K880169	Cemax 5000 Multidimensional Imaging Workstation	Cemax, Inc.	LLZ	Class II	1988-03-09
K880082	Memorymate Hearing Aid Model 8200	3M Company	ESD	Class I	1988-03-09
K875383	Lake Catheter Care Kits (Modification)	Lake Medical Products, Inc.	KOD	Class II	1988-03-09
K875257	Impregum F Adhesive	Espe GmbH (US)	EBH	Class I	1988-03-09
K875228	Permadyne Adhesive	Espe GmbH (US)	EBH	Class I	1988-03-09
K875089	Hepcon System B-10 Activated Clot Time & Heparin	Hemotec, Inc.	JPA	Class II	1988-03-09
K875047	Coulter Clone T11 Monoclonal Antibody	Coulter Electronics, Inc.	GKZ	Class II	1988-03-09
K873807	Autotransfusion Apparatus	Biodynamics Corp.	CAC	Class II	1988-03-09
K873498	Inspiratory Force Mont Kit/manifold/meter/tubing	Dhd Medical Products Div. Diemolding Corp.	BXR	Class II	1988-03-09