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 2026-10-29, 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 2627 of 3530

510(k) clearances, page 2627 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K892394	P.f.c. Modular Knee System, Tibial Tray-Porous	Johnson & Johnson Professionals, Inc.	JWH	Class II	1989-07-19
K892366	Porous Genesis Stemmed Tibial Component	Richards Medical Co., Inc.	JWH	Class II	1989-07-19
K892059	Femoral Heads/modular & Fixed W/ Titan Nitride Sur	Protek, Inc.	LZY	Class II	1989-07-19
K890963	Sim 4000I Ultrasound System-Transducer for Sm 24/4	Esaote Biomedica Elettronica	IYO	Class II	1989-07-19
K890132	Porous Genesis Patellar and Stemless Tibial Comp.	Richards Medical Co., Inc.	JWH	Class II	1989-07-19
K892389	Biopsy Kit	I M, Inc.	LRO	Class II	1989-07-17
K894284	Gown, Operating, Surgical	Miroz Industries Co.	FYA	Class II	1989-07-14
K894040	Implantable Pacing Leads W/is-1 Conn., Unipolar	Medtronic, Inc.	DTB	Class III	1989-07-14
K894039	Quidel Total Ige Test Quantitative Version	Ortho-Clinical Diagnostics, Inc.	DGO	Class II	1989-07-14
K894034	Modified Labeling of Surgical Gloves	James River Corp.	KGO	Class I	1989-07-14
K894017	Power Podiatry Chair/table #414, #416 & #417	Midmark Corp	INQ	Class I	1989-07-14
K893969	Decubitus Care Pad	Gulftrade Exim, Inc.	FWZ	Class I	1989-07-14
K893951	Pharmacia Cap System Ige Ria and Feia	Pharmacia, Inc.	DGC	Class II	1989-07-14
K893939	Isolation Masks	James River Corp.	FXX	Class II	1989-07-14
K893906	Gold Class Grandtex/multiple(mfg:zhuhai Gold Class	Minette Sales Corp.	LYY	Class I	1989-07-14
K893902	4 X 4 Sterile Gauze Sponge Tray	Mumtaz I. Malik	EFQ	Unclassified	1989-07-14
K893901	Latex Examination Gloves	Tillotson Corp.	LYY	Class I	1989-07-14
K893896	Quantitative Assay for Det. of Igg Igm Anti-Dsdna	Biostar Medical Products, Inc.	LKJ	Class II	1989-07-14
K893870	Adams Breast Implant Protector	Adept-Med Intl., Inc.	GCZ	Class I	1989-07-14
K893813	Floor Standing, Operating and Examining Light	Astralite Corp.	FSS	Class II	1989-07-14
K893782	Patient Examination Gloves W/corn Starch Powder	Rubberex (M) Sdn Berhad	LYY	Class I	1989-07-14
K893763	Models 1113 and 1114 Pacemaker Leads	Possis Medical, Inc.	DTB	Class III	1989-07-14
K893754	Cefixime, 5 Mcg Sensi-Disc Antimic Suscep Test Dis	BD Becton Dickinson Vacutainer Systems Preanalytic	JTN	Class II	1989-07-14
K893739	Vista Mr 2055 Hp System and 2055 Upgrades	Philips North America LLC	LNH	Class II	1989-07-14
K893732	Aspen Disposable Bipolar Cord	Conmedcorp	GEI	Class II	1989-07-14
K893675	Vista Mr 2055 Hp System and 2055 Upgrades	Philips North America LLC	LNH	Class II	1989-07-14
K893659	Electrosurgery Analyzer Rf302	Bio-Tek Instruments, Inc.	GEI	Class II	1989-07-14
K893642	Modified Endoguide	Luxar Corp.	GEX	Class II	1989-07-14
K893617	Mobile C-Arm	Acoma Medical Imaging, Inc.	OXO	Class II	1989-07-14
K893611	Bard Plaque Electrode Array	Bard Electrophysiology	DRF	Class II	1989-07-14
K893603	Remove Adhesive Remover	Smith & Nephew United, Inc.	KOX	Class I	1989-07-14
K893594	Latex Examination Gloves	Glovetex Industries	LYY	Class I	1989-07-14
K893566	Argenco 50 Type IV Type IV Dental Gold Alloy	Argen Precious Metals, Inc.	EJT	Class II	1989-07-14
K893562	A.qc Hct Level 1 and 2	Johnson & Johnson Professionals, Inc.	GLK	Class II	1989-07-14
K893555	X-Ring and Speed Stix Plastic Ligatures	American Orthodontics	EJF	Class I	1989-07-14
K893551	Latex Examination Gloves	Mlb Holdings Sdn. Bhd.	LYY	Class I	1989-07-14
K893550	Plastic Force Module	American Orthodontics	EJF	Class I	1989-07-14
K893527	Laparoscopic Suction Probe	Dexide, Inc.	JOL	Class II	1989-07-14
K893484	Multiphase Orthodontic Wire	American Orthodontics	EJF	Class I	1989-07-14
K893483	Bondable Retainer and Space Maintainer	American Orthodontics	EJF	Class I	1989-07-14
K893481	Crystar(tm) Anti-Greening Liquid	Shofu Dental Corp.	ELL	Class II	1989-07-14
K893468	Cmv Igg Antibody Test (Indirect Fluorescent Test)	IMMUNO CONCEPTS, NA, Ltd.	LIN	Class II	1989-07-14
K893467	Cmv Igg Antibody Test (Indirect Enzyme Test)	IMMUNO CONCEPTS, NA, Ltd.	LIN	Class II	1989-07-14
K893466	Cmv Igm Antibody Test (Indirect Enzyme Test)	IMMUNO CONCEPTS, NA, Ltd.	LKQ	Class II	1989-07-14
K893436	Modified Sterilization Method of Pti Heart-Lift	Pioneering Technologies, Inc.	DWS	Class I	1989-07-14
K893425	Vitatrace	Lectec Corp.	DRX	Class II	1989-07-14
K893353	Latex Examination Gloves	Chorng Rong Industrial Co., Ltd.	LYY	Class I	1989-07-14
K893352	Latex Examination Gloves	Hua Shu-Yee Industrial Co., Ltd.	LYY	Class I	1989-07-14
K893347	Latex Examination Gloves	Changzhou Foreign Economic Technical and Trading	LYY	Class I	1989-07-14
K893333	Latex Examination Gloves	Ever Shine Industrial, Ltd.	LYY	Class I	1989-07-14