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 2026-11-05, 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 2237 of 3531

510(k) clearances, page 2237 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K932933	Gc IV Coronary Guiding Catheter	Medtronics Interventional Vascular	DQY	Class II	1994-02-01
K932441	Series 8920 Trocar System	Richard Wolf Medical Instruments Corp.	GCJ	Class II	1994-02-01
K931362	Il Test Calcium	Instrumentation Laboratory Co.	CIC	Class II	1994-02-01
K931108	Ez Grip Reusable Tens/nmes Electrodes	Advanced Adhesives	GZJ	Class II	1994-02-01
K930872	Alpha-Dent Root Canal Sealer; Wach's Formula	Wallace A. Erickson & Co.	KIF	Class II	1994-02-01
K930571	Reusable Handle for Laparoscopic Inst. W/rotating	Numed Technologies, Inc.	HFI	Class II	1994-02-01
K930531	Ame(r) Rigid Fixation System	American Medical Electronics, Inc.	KWP	Class II	1994-02-01
K930335	Profast - Denture Adhesive for Lower Jaws	Fittydent-Altwirth & Schmitt GmbH	KOO	Class I	1994-02-01
K926387	Techmedica Standard Cemented Hip System	Techmedica, Inc.	KWY	Class II	1994-02-01
K925745	Ati(r) Disp Biological-Plus Test Pack	Pymah Corp.	FRC	Class II	1994-02-01
K925496	Ati Disposable Biological-Plus Test Pack	Pymah Corp.	FRC	Class II	1994-02-01
K925049	Quest Heart Insulation Pad	Quest Medical, Inc	DWF	Class II	1994-02-01
K923705	Aesculap Craniofacial Titanium Plates and Screws	Aesculap Inc	JEY	Class II	1994-02-01
K935957	Fuji Medical Film Processor Fpm2800	FUJIFILM Healthcare Americas Corporation	IXW	Class II	1994-01-31
K935934	Non Adherant Burn Pads	McNeil Healthcare LLC	EFQ	Unclassified	1994-01-31
K935911	Packing Sponge	McNeil Healthcare LLC	EFQ	Unclassified	1994-01-31
K935910	X-Ray Packing Sponge	McNeil Healthcare LLC	GDY	Class I	1994-01-31
K935882	Tonsil Sponges	McNeil Healthcare LLC	GDY	Class I	1994-01-31
K935881	Specialty Sponges	McNeil Healthcare LLC	GDY	Class I	1994-01-31
K935762	Auto Suture Disposable Endoscopic Suture Needle	United States Surgical, A Division of Tyco Healthc	GCJ	Class II	1994-01-31
K935709	General Surgery Probe/general Surgery Probe W/distal Perforations	Zimmer Patient Care Division	GCJ	Class II	1994-01-31
K935153	Dentaurum Bracket Positioning Gauge	Dentauraum, Inc.	ECQ	Class I	1994-01-31
K935152	Dentaurum Dentaform Bands, Dentaurum Standard	Dentauraum, Inc.	DYO	Class I	1994-01-31
K935149	Sonibrush	American Dentronics, Inc.	JEQ	Class I	1994-01-31
K935148	Sonifloss	American Dentronics, Inc.	JEQ	Class I	1994-01-31
K935143	Dentaurum Stainless Steel Tubing	Dentauraum, Inc.	DZD	Class I	1994-01-31
K935142	Dentaurum Wires	Dentauraum, Inc.	DZC	Class I	1994-01-31
K935141	Dentaurum Pliers	Dentauraum, Inc.	JEX	Class I	1994-01-31
K935129	Relisa Ena Antibody Screening Test System	IMMUNO CONCEPTS, NA, Ltd.	LLL	Class II	1994-01-31
K935122	Dentaurum Metal Brackets	Dentauraum, Inc.	EJF	Class I	1994-01-31
K935073	Non-Insulated Scissors	Karl Storz Endoscopy-America, Inc.	GCJ	Class II	1994-01-31
K934870	Lorad D-550	Lorad Corp.	IZH	Class II	1994-01-31
K934748	Lorad M-Iie Modification	Lorad Corp.	IZH	Class II	1994-01-31
K933721	Epidural Anesthesia Procedure Tray, Custom	Neurodelivery Technology, Inc.	CAZ	Class II	1994-01-31
K933455	Computed Oral Radiology System	Schick Technologies, Inc.	EAP	Class II	1994-01-31
K933062	B-D(r) Challenge Powder Free Synthetic Surg Gloves	BD Becton Dickinson Vacutainer Systems Preanalytic	KGO	Class I	1994-01-31
K932888	Intersect Systems Direct Amylase Reagent	Intersect Systems, Inc.	JFJ	Class II	1994-01-31
K932611	Neuromuscular Stimulator	Myo/Kinetic Systems, Inc.	GZJ	Class II	1994-01-31
K932353	HF-110A	Dynarad Corp.	IZL	Class II	1994-01-31
K931555	Artromot K2 Cpm	Ormed Mfg., Inc.	BXB	Class I	1994-01-31
K926212	Arthrex Instruments ( Hip )	Arthrex GmbH	HRX	Class II	1994-01-31
K925119	A-Dec 1040 Chair	A-dec, Inc.	KLC	Class I	1994-01-31
K925080	Tek-Lube	Clinical Technology Inc.	EFB	Class I	1994-01-31
K925006	Hydro-Temp NICU and Skin Surface Temperature Senso	DeRoyal Industries, Inc.	FMT	Class II	1994-01-31
K923534	Pm2002 Proline	Planmeca U.S.A. Inc	KLC	Class I	1994-01-31
K936134	Berman Airway	Smiths Industries Medical Systems, Inc.	CAE	Class I	1994-01-28
K935973	Argistar 72 (High Gold Platinum Silver Alloy for Both Low Fusing Porcelain and Crown and Bridge Application	Argen Precious Metals, Inc.	EJT	Class II	1994-01-28
K935642	Evans Medical Extension Sets	Evans Medical, Inc.	FPK	Class II	1994-01-28
K935641	0.2. Micron Filter Sets and 1.2 Micron Filter Sets	Evans Medical, Inc.	FPB	Class II	1994-01-28
K935528	Dupont Aca(r) Plus Immunoassay Sys Ferritin(ferr) Meth	E.I. Dupont de Nemours & Co., Inc.	DBF	Class II	1994-01-28