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 2026-10-12, 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 3327 of 3528

510(k) clearances, page 3327 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K802696	Dental Mouth Prop.	Trident Dental, Inc.	JXL	Class II	1980-11-12
K802694	Jacob Chuck	Richard Wolf Medical Instruments Corp.	LXH	Class I	1980-11-12
K802685	Reolit	Vivadent (USA), Inc.	EJK	Class II	1980-11-12
K802680	Isopast-Ds	Vivadent (USA), Inc.	EBF	Class II	1980-11-12
K802677	Closed-End/open-End Colostomy Pch. W/con	Johnson & Johnson Professionals, Inc.	EXB	Class I	1980-11-12
K802676	Orhtopedic Reamer 87 Htd	Zimmer GmbH	HTD	Class I	1980-11-12
K802673	Knee Brace/stabilizer	Omni Scientific, Inc.	ITQ	Class I	1980-11-12
K802669	Cybrex Amikacin	Abbott Medical	KLQ	Class II	1980-11-12
K802665	Touchless Clean-Cath	Diamed Division Ill. Tool Works, Inc.	KOD	Class II	1980-11-12
K802664	Urinary Drainage Unt	Diamed Division Ill. Tool Works, Inc.	KNX	Class II	1980-11-12
K802663	Blow-by-Set-Up Connector-Airway	Airlife, Inc.	BZA	Class I	1980-11-12
K802659	Respiratory Therapy Flowmeter	Design & Manufacturing Consultants	CAX	Class I	1980-11-12
K802657	Model Afr EEG Telephone Receiver	Telediagnostic Systems, Inc.	GYE	Class II	1980-11-12
K802654	Ames Tda Primidone Test	Miles Laboratories, Inc.	DJD	Class II	1980-11-12
K802652	Boundary Surgical Drapes with Adhesive	Procter & Gamble Mfg. Co.	KKX	Class II	1980-11-12
K802650	Uca Lotion Product Reformulation	Vanaray Laboratories, Inc.	GYB	Class II	1980-11-12
K802649	Uca Gel Product Reformaulation	Vanaray Laboratories, Inc.	GYB	Class II	1980-11-12
K802646	Hand Percussor Cup #65210	B & F Medical Products, Inc.	BYI	Class II	1980-11-12
K802642	Utah Artifical Arm	Motion Control, Inc.	IRE	Class I	1980-11-12
K802640	Ohio Gc Incubator	Ohio Medical Products	FMZ	Class II	1980-11-12
K802639	Ohio Ic Incubator	Ohio Medical Products	FMZ	Class II	1980-11-12
K802638	Otological Ventilation Tubes	Santa Barbara Medco, Inc.	ETD	Class II	1980-11-12
K802626	Anairobe-Tek	Flow Laboratories, Inc.	JSP	Class I	1980-11-12
K802624	Emit-Stm Urine Calibrators	Syva Co.	DKB	Class II	1980-11-12
K802623	Emit-Stm Amphetamine Assay	Syva Co.	DKZ	Class II	1980-11-12
K802611	Auto Suture Dispos., Eea Surg. Stapler	U. S. Surgical Corp.	GAG	Class II	1980-11-12
K802605	Electro Surgical Tip Cleaner	Concept, Inc.	GEI	Class II	1980-11-12
K802603	Econo-Float Wheelchair Flotation Cushion	Jefferson Industries, Inc.	KID	Class I	1980-11-12
K802602	L-3 Purge Line	Delta Medical Industries	DTM	Class II	1980-11-12
K802600	Amp Portable Patient Pressure Monitor	American Medical Products LLC	DSK	Class II	1980-11-12
K802597	Telesonic Arcon & Soundex Asp 101	Telesonic, Inc.	ESD	Class I	1980-11-12
K802596	Telesonic, Arcon & Soundex Asp 102	Telesonic, Inc.	ESD	Class I	1980-11-12
K802595	Ergo Irrigation System	Ergo Instruments, Inc.	EFS	Class I	1980-11-12
K802594	Beckman Dp-5500 Data Reduction System	Beckman Instruments, Inc.	JQP	Class I	1980-11-12
K802592	Paragon Serum Protein Electrophoresis	Beckman Instruments, Inc.	CEF	Class I	1980-11-12
K802591	Model 5460 + 5480 Pop-Off Valves	G. Dundas Co.	BSZ	Class II	1980-11-12
K802587	Otological Ventilation Tubes	Humboldt Products	ETD	Class II	1980-11-12
K802581	Bekcman Astra Systems Amylase Chemistry	Beckman Instruments, Inc.	JFJ	Class II	1980-11-12
K802580	Subclavian Catheter Insertion Tray	American Pharmaseal Div. Ahsc	KXF	Class I	1980-11-12
K802579	Cybrex Tm Fpq Fluorescene Polarization	Abbott Medical	KHO	Class I	1980-11-12
K802577	Hyperalimentation Subclaviian Dress Tray	Associated Medical Products Co.	FRG	Class II	1980-11-12
K802576	External Jugular Cvp Catherization Kit	Willson	DRX	Class II	1980-11-12
K802574	Beckman Liquid Stat Liquid/alkaline Pho	Beckman Instruments, Inc.	CJE	Class II	1980-11-12
K802572	Beckman Liquid-Stat Ld-L-UV Enzyme	Beckman Instruments, Inc.	CFJ	Class II	1980-11-12
K802569	Abnormal Hemoglobin Control	Marilyn L. Amick	KHG	Class II	1980-11-12
K802568	Hemoglobin Control	Marilyn L. Amick	KHG	Class II	1980-11-12
K802564	Medical Magnetic Tape Recorder	Medical Concepts	DSH	Class II	1980-11-12
K802562	Prisma Seal	Dentsply Intl.	EBC	Class II	1980-11-12
K802560	Tinnitus Research Audiometer	Starkey Laboratories, Inc.	EWO	Class II	1980-11-12
K802557	Emergency Department Laceration Kit-	Johnson & Johnson Professionals, Inc.	KDD	Class I	1980-11-12