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 3096 of 3528

510(k) clearances, page 3096 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K840422	Devon Head Rest	Devon Industries, Inc.	FWZ	Class I	1984-03-12
K840421	Ulnar Nerve Protector	Devon Industries, Inc.	FWZ	Class I	1984-03-12
K840403	Vena * Bridge	Neward Enterprises, Inc.			1984-03-12
K840401	Biopsy Needles Various	E-Z-EM, Inc			1984-03-12
K840354	Monoject Soft Tissue Biopsy/fine Needle	Sherwood Medical Co.	FCG	Class II	1984-03-12
K840320	Cat. 16-Immunology Devices	Imm Enterprises, Ltd.	HTD	Class I	1984-03-12
K840319	Cat 15-Hematology & Pathology Device	Imm Enterprises, Ltd.	HTD	Class I	1984-03-12
K840317	Cat 13-Clinical Chemistry Devices	Imm Enterprises, Ltd.	HTD	Class I	1984-03-12
K840316	Cat 12-Orthopedic & Rehab Device	Imm Enterprises, Ltd.	HTD	Class I	1984-03-12
K840315	Cat 11- General & Plastic Surgery Dev	Imm Enterprises, Ltd.	HTD	Class I	1984-03-12
K840309	Cat. 5-Radiology Devices	Imm Enterprises, Ltd.	HTD	Class I	1984-03-12
K840307	Cat. 3 Gastroenterology-Urology Dev	Imm Enterprises, Ltd.	HTD	Class I	1984-03-12
K840306	Category 2 Gen. Hospital & Personal Use	Imm Enterprises, Ltd.	HTD	Class I	1984-03-12
K840302	Plt - 4 Platelet	R & D Systems, Inc.	JPK	Class II	1984-03-12
K840168	Westerman-Jensen Biopsy Needle	Popper & Sons, Inc.	FCG	Class II	1984-03-12
K840157	Millereisen Curved Biopsy Needle	Preventive Medicine Institute	FCG	Class II	1984-03-12
K840110	Laerdal Suction Unit	Laerdal Medical a/S	BTA	Class II	1984-03-12
K834514	Fascia Cutter	Stryker Corp.	GES	Class I	1984-03-12
K834431	Pacing Electrode	Pacesetter Systems	DTB	Class III	1984-03-12
K834267	Ligaclip Metallic Ligating Clip	Ethicon, Inc	FZP	Class II	1984-03-12
K834255	Pbc Scalp Vein Set	Philadelphia Biologics Center	FOZ	Class II	1984-03-12
K834249	Monoject Soft Tissue Biopsy Needle	Sherwood Medical Co.	FCG	Class II	1984-03-12
K834108	Needle Bender Tx8225	Today'S Machining & Design, Inc.	LXH	Class I	1984-03-12
K833962	Kpe Plus-Pak Surgical System	Ipax, Inc.	HQC	Class II	1984-03-12
K833961	I/a Plus Pak Surgical System	Ipax, Inc.	HQC	Class II	1984-03-12
K833916	Hypafix Dressing Retention Sheet	Smith & Nephew, Inc.	KGX	Class I	1984-03-12
K833834	Ortho Bacteriuria Detection Sys	Ortho Diagnostic Systems, Inc.	JXA	Class I	1984-03-12
K833801	Right Coronary Guiding Catheter	Advanced Cardiovascular Systems, Inc.	DQY	Class II	1984-03-12
K833554	Material Addition Lexan & K-Resin	Procedure Products, Inc.	DQO	Class II	1984-03-12
K833446	Downing Spectral Illuminator	Vision Health Technology	HLX	Class II	1984-03-12
K833418	Chymofast Test	Allergenetics	DHB	Class II	1984-03-12
K832369	Vascular Recorder #301	Imex Medical Systems, Inc.	JOP	Class II	1984-03-12
K831926	Implantable Endocardial Pacing Leads	Oscor Inc.	DTG	Class I	1984-03-12
K840705	Paramax Alanine Aminotransferase	American Dade	CKA	Class I	1984-03-09
K840639	Poirier Commodes	Poirier S.A.			1984-03-09
K840615	Yersinia Supplement	Remel Co.	JSI	Class I	1984-03-09
K840589	Tri-Tube Ria	Nuclear Medical Laboratories, Inc.	KHQ	Class II	1984-03-09
K840564	Liqui Zyme Total Bilirubin Reagent	American Research Products Co.	CIG	Class II	1984-03-09
K840539	Dispos. Low Press. Cuffed Tracheostomy	Shiley, Inc.	BTO	Class II	1984-03-09
K840517	Protozoa Stain Control	Scientific Device Laboratory, Inc.	LJG	Class I	1984-03-09
K840516	Metachromatic Granule Stain Control	Scientific Device Laboratory, Inc.	LJG	Class I	1984-03-09
K840515	Acid Fast Bacilli Stain Control	Scientific Device Laboratory, Inc.	LJG	Class I	1984-03-09
K840404	Diffu-Gen Haptoglobin Radial Immuno	Tago, Inc.	DAD	Class II	1984-03-09
K840360	Allercoat Multiscreen Discs	Kallestad Laboratories, Inc.	DHB	Class II	1984-03-09
K840223	Orion Biofeedback Data Acquisition	Self Regulation Systems, Inc.	HCC	Class II	1984-03-09
K840044	Sdi Prepax Dilukit 29-1000	Scientific Distributors, Inc.	JJO	Class I	1984-03-09
K834601	Avl Model 945 Blood Gas System	Avl Scientific Corp.	CHL	Class II	1984-03-09
K834586	Leeco E2 Quant Diag. Test Kit	Leeco Diagnostics, Inc.	CHP	Class I	1984-03-09
K834534	Apsara Analyzer	Datachem, Inc.	JJE	Class I	1984-03-09
K834389	Ams Gram-Positive Ident. Card	Vitek Systems, Inc.	JTO	Class I	1984-03-09