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 3118 of 3528

510(k) clearances, page 3118 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K823934	Cariel F12	Odam	DYC	Class II	1983-12-16
K834088	Gel-Scan Diagnostic Ultrasound Coupling	Whs Products, Inc.	HEM	Class II	1983-12-15
K833717	Padgett Suction Cannula	Advanced Biosearch Assn.	GEA	Class I	1983-12-14
K833252	Erika Di-Ala-Kit-Single Dialysis On/of	Erika, Inc.	KOC	Class II	1983-12-14
K831841	Sterile Disp. Instrument Trays	E.M. Adams Co., Inc.	KDD	Class I	1983-12-14
K834165	Syringe	Elfa Trading Co.	FMF	Class II	1983-12-13
K834164	Spinal Needles & Accessory	Elfa Trading Co.	FPK	Class II	1983-12-13
K832050	Mortara Instrument #101	Mortara Instrument, Inc.	DPS	Class II	1983-12-13
K834077	Single Use Nebulizer-Adjust-Air Entrain	Airlife, Inc.	CAF	Class II	1983-12-12
K833995	Mini Ox II	Catalyst Research Corp.	CCL	Class II	1983-12-12
K833994	Pulsair I & II	Cryo Corp.	BYJ	Class II	1983-12-12
K833887	Brucella Broth	Oxoid U.S.A., Inc.	JSJ	Class I	1983-12-12
K833886	Brucella Agar	Oxoid U.S.A., Inc.	JSJ	Class I	1983-12-12
K833865	Ace Brooker Bone Plating System	Buckman Co., Inc.	HRS	Class II	1983-12-12
K833862	Thayer Martin Agar	American Biomedical Corp.	JTY	Class II	1983-12-12
K833847	Crisa	X-Ray Tube Corp.	ITY	Class I	1983-12-12
K833812	Superjet Disposable Blood Lancet	Medrobe Laboratories	FMK	Class II	1983-12-12
K833808	Nutra-Tone 500	Applied Optic Kinetics, Ltd.	IPF	Class II	1983-12-12
K833732	Non Wetting Undercast Padding	American Medical Disposable, Inc.	ITG	Class I	1983-12-12
K833727	Cabot Arthroscopy System	Cabot Medical Corp.	HRX	Class II	1983-12-12
K833675	Brigham Tibial Cement Pressurizer	Howmedica Corp.	KIH	Class I	1983-12-12
K833613	Fluor-B Mel a Direct Fluorescent Anti	Petra Biomedical Products, Inc.	JSS	Class I	1983-12-12
K833612	Fluor-B. Frag. Direct Fluorescent Anti	Petra Biomedical Products, Inc.	JSS	Class I	1983-12-12
K833501	Medi-Mist Porta. Compressor Driven	Mountain Medical Equipment, Inc.	BTI	Class II	1983-12-12
K833435	Multi Purpose Syringe	I M, Inc.	FMF	Class II	1983-12-12
K833357	Vydax 525-550 & 5100 Fluorotelomer	Ethicon, Inc	GDT	Class I	1983-12-12
K833093	Vanish II	Warner-Lambert Co.	KGO	Class I	1983-12-12
K833059	Suction Catheter Trays	Intermed, Inc.	GBZ	Class I	1983-12-12
K832978	Meniscal Suture Gun	Instrument Makar, Inc.	GDF	Class I	1983-12-12
K832908	Comfeel Protective Rings	MEDLINE INDUSTRIES, LP - Northfield	EYF	Class I	1983-12-12
K832531	Photometer Lp 300	Dr. Bruno Lange GmbH	JJQ	Class I	1983-12-12
K831489	Surgical Tube Holder	The Urology Group	GEI	Class II	1983-12-12
K832177	Pulsair Model Sp-1	Thermowave Medical Device Corp.	IRQ	Class I	1983-12-09
K832153	Pdm Siloxane Prosthetic Nose	Delaware Prosthetics, Inc.	GBI	Class I	1983-12-09
K832152	Pdm Siloxane Prosthetic Ear	Delaware Prosthetics, Inc.	GBI	Class I	1983-12-09
K833938	Catalog 6400 Oxygen Concentrator	Hudson Oxygen Therapy Sales Co.	CAW	Class II	1983-12-08
K833922	Brethancer, Drug Delivery Sys-Inhal	Ciba-Geigy Corp.	CAF	Class II	1983-12-08
K833901	Bactrol Gram Slide	Difco Laboratories, Inc.	JTO	Class I	1983-12-08
K833861	Mueller Hinton Agar	American Biomedical Corp.	JTZ	Class II	1983-12-08
K833858	Coagulase Plasma, Horse & Rabbit Edta	Otisville Biotech, Inc.	JTL	Class I	1983-12-08
K833848	Dual Lumen Subclavian Cannula	Shiley, Inc.	LFJ	Class II	1983-12-08
K833803	Oticon, E26p	Oticon, Inc.	ESD	Class I	1983-12-08
K833775	Behind-the-Ear Hearing Aids T-87 &	Bernafon LLC	ESD	Class I	1983-12-08
K833748	Rescue Valve	Respironics, Inc.	CBP	Class II	1983-12-08
K833633	Bronchitrac Df Dual Resp/catheter	Ackrad Laboratories	BSY	Class I	1983-12-08
K833623	Modif. of Emit Cad Disopyramide Assay	Syva Co.	KLR	Class II	1983-12-08
K833560	Rtp-5100-5200-5300 & 5400	Philips North America LLC	JAD	Class II	1983-12-08
K833546	Modification of Emit and Amikacin Assay	Syva Co.	LDN	Class II	1983-12-08
K833531	CT Scanning Accessories	Lds Hospital	JAA	Class II	1983-12-08
K833514	Toxi Chem Serum Alcohol Control	Fisher Diagnostics	DKC	Class I	1983-12-08