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 2026-10-15, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,969 of the 176,366 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	2,569

176,366 records, page 3116 of 3528

510(k) clearances, page 3116 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K833468	Bdh Universal Hip System Surgeon	Carbomedics, Inc.	JDG	Class II	1983-12-27
K833461	Hs4 Head/neck Femoral Prostheses	Osteonics Corp.			1983-12-27
K833384	Procainamide Analytical Test Pack	E.I. Dupont de Nemours & Co., Inc.	LAR	Class II	1983-12-27
K833383	Procainamide Calibrator	E.I. Dupont de Nemours & Co., Inc.	DLJ	Class II	1983-12-27
K833382	Valproic Acid Calibrator	E.I. Dupont de Nemours & Co., Inc.	DLJ	Class II	1983-12-27
K833381	Valproic Acid Analytical Test Pack	E.I. Dupont de Nemours & Co., Inc.	KLR	Class II	1983-12-27
K833380	Lidoaine Calibrator	E.I. Dupont de Nemours & Co., Inc.	DLJ	Class II	1983-12-27
K833379	Lidocaine Analytical Test Pack Aca	E.I. Dupont de Nemours & Co., Inc.	KLR	Class II	1983-12-27
K833378	N-Acetylprocainamide Aca-Analytical	E.I. Dupont de Nemours & Co., Inc.	LAN	Class II	1983-12-27
K833308	Dual Lumen Needle	Quinton, Inc.	KOC	Class II	1983-12-27
K833307	Phadeback G.c. Positive Controls	Pharmacia, Inc.	JSX	Class I	1983-12-27
K833303	Duoflo 6F	Argon Medical Corp.	DQY	Class II	1983-12-27
K833297	Bronchoscopy Tube W/ultra Locuff	Surgitek	BTS	Class II	1983-12-27
K833294	Alpha Y-Recipient Set	Alpha Therapeutic Corp.	BRZ	Class II	1983-12-27
K833014	Ebv-Vca-Igm Ifa Test System	Zeus Scientific LLC	LJN	Class I	1983-12-27
K832873	Mumps Complement Fixation & Hemagglu	Hazleton Dutchland, Inc.	GRC	Class I	1983-12-27
K832697	Rmp Intubation Equip. Storage Tray	Rmp Co.	BZN	Class I	1983-12-27
K832671	Cardiotomy Reservoir-Filter 050-108-050	Cobe Laboratories, Inc.	DTN	Class II	1983-12-27
K832607	Open End Spring Guide	C.R. Bard Inc	DQX	Class II	1983-12-27
K832543	Male Therapeutic Potent Aid	Mace'S Scientific	LKY	Class II	1983-12-27
K832508	Volume Ventilator	Sechrist Industries Inc	CBK	Class II	1983-12-27
K832285	Volumetric Pump Set 2C9100 for Nitrogly	Travenol Laboratories, S.A.	FRN	Class II	1983-12-27
K832192	Suction-Hemorrhoid-Ligator	Research Endoscope Systems Intl.	FHN	Class II	1983-12-27
K833616	Olbert Catheter System	Meadox Medicals, Div. Boston Scientific Corp.	LIT	Class II	1983-12-26
K833485	Impression Tube Adjustable	Zefr, Inc.	EHY	Class I	1983-12-26
K833445	Deguplus 2	Degussa Dental, Inc.	EJS	Class II	1983-12-26
K833280	Supra Ap Choice 83	Genesis Industries, Inc.	EIS	Class I	1983-12-26
K833021	Peri-Guard Pericardial Patch-Hernia	Genetic	DXZ	Class II	1983-12-26
K833945	Cosmodyn-S Interferential Muscle Stim	Leo Unlimited, Inc.	IPF	Class II	1983-12-23
K832967	Duckbill Voice Prosthesis & Tracheo	American V. Mueller	EWL	Class II	1983-12-23
K832805	Bionicare Stimulator Bio-1	Murray Electronics	IPF	Class II	1983-12-23
K834063	Sterile Rubber Bands	Devon Industries, Inc.	LDQ		1983-12-22
K834019	Biggy Agar Nickerson Medium	Micro Media Laboratories	JSI	Class I	1983-12-22
K834018	Campy Medium	Micro Media Laboratories	JSJ	Class I	1983-12-22
K834017	Chocolate Agar W/chemically Defined	Micro Media Laboratories	JSJ	Class I	1983-12-22
K834016	Gn Broth	Micro Media Laboratories	JSG	Class I	1983-12-22
K834015	Selenite Broth	Micro Media Laboratories	JSD	Class I	1983-12-22
K834014	Potato Dextrose Agar	Micro Media Laboratories	JSG	Class I	1983-12-22
K834012	Sim Medium	Micro Media Laboratories	JSE	Class I	1983-12-22
K834009	Simmons Citrate Agar	Micro Media Laboratories	JSH	Class I	1983-12-22
K834007	Cystine Tryptic Medium	Micro Media Laboratories	JSQ	Class I	1983-12-22
K834004	Mycobiotic Agar	Micro Media Laboratories	JSE	Class I	1983-12-22
K834003	Motility Indole Ornithine-Medium	Micro Media Laboratories	JSE	Class I	1983-12-22
K834002	Lysine Iron Agar	Micro Media Laboratories	JSE	Class I	1983-12-22
K834001	Kligler Iron Agar	Micro Media Laboratories	JSE	Class I	1983-12-22
K833988	Api Staphase III	Analytical Products, Inc.	JTL	Class I	1983-12-22
K833912	Galante Fiber Metal Total Hip	Zimmer GmbH	JDI	Class II	1983-12-22
K833900	Bactrol Tb Slide	Difco Laboratories, Inc.			1983-12-22
K833816	Hemastick 1-1.5 & 2-Dispos. Blood	Medprobe Laboratories	FMK	Class II	1983-12-22
K833786	Microprocessor Ventilator 7200	Medtronic, Inc.	CBK	Class II	1983-12-22