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 2026-10-19, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 3046 of 3529

510(k) clearances, page 3046 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K843314	Mpl Hypo Brand Breech Load Aspir Syringe	Smith & Nephew, Mpl Division	EJI	Class II	1984-09-27
K843223	Flow Controller	Precision Medical, Inc.	BTM	Class II	1984-09-27
K843218	Tps Screw Dental Implants	Artech Corp.	DZE	Class II	1984-09-27
K843153	Anterior Alveolar Ridge Sizer	Interpore Intl.	LYC	Class II	1984-09-27
K843143	Stabilizing Retainer	Dental Advancements, Inc.	EJF	Class I	1984-09-27
K843100	Instruments for Micro Anastomosis	Downs Surgical, Ltd.	GAD	Class I	1984-09-27
K843046	Reliance Treatment Cabinet	F. & F. Koenigkramer	ETF	Class I	1984-09-27
K843026	Kerr Gelled Phosphoric Acid Etchant	Kerr Corporation (Danbury)	EBF	Class II	1984-09-27
K843024	Command Ultraseal Pit & Fissure Sealant	Kerr Corporation (Danbury)	EBC	Class II	1984-09-27
K843018	Flexi-Post	Essential Dental Systems, Inc.	ECR	Class I	1984-09-27
K842960	Androstenedione by Ria	Radioassay Systems Laboratories, Inc.	CIZ	Class I	1984-09-27
K842576	Clear Liner	Harry J. Bosworth Co.	EBI	Class II	1984-09-27
K842448	Bosworth Super Bond Dental Adhesive	Harry J. Bosworth Co.	DYH	Class II	1984-09-27
K842093	Mk 700 Ultrasound System	Advanced Technology Laboratories, Inc.	IYO	Class II	1984-09-27
K833377	Medicalex	Medicalex	GEA	Class I	1984-09-27
K843552	Triglycerides Gpo Reagent	Bio-Rad	CDT	Class I	1984-09-26
K843507	Emit 700 Calibrator B	Syva Co.	DKB	Class II	1984-09-26
K843460	Ultraviolet-Visible Spectrophotometer	Varian Assoc., Inc.	JJQ	Class I	1984-09-26
K843420	Emit 700 Cannabinoid Calibrator	Syva Co.	DLJ	Class II	1984-09-26
K843281	Accuscreen Tsh	Neometrics, Inc.	JLW	Class II	1984-09-26
K843242	Tricon M Tibial Component	Richards Medical Co., Inc.	JWH	Class II	1984-09-26
K843241	Tricon-P Tibial Component	Richards Medical Co., Inc.	JWH	Class II	1984-09-26
K843184	Stratus Lidocaine Fluorometric Enzyme	American Dade	KLR	Class II	1984-09-26
K843135	Brimfield Cannulated Magnetic Retriever	Brimfield Scientific Instruments	FCC	Class II	1984-09-26
K843063	Electronic Epilator Ts-1	R. A. Fischer Co. Corp.	KCW	Class I	1984-09-26
K842815	Emit D.a.u. Benzodiazepine Assay	Syva Co.	JXM	Class II	1984-09-26
K842748	Surgitek Reconstruc-Nipple Prosthesis	Medical Engineering Corp.			1984-09-26
K842677	Emit D.a.u. Opiate Assay	Syva Co.	DJG	Class II	1984-09-26
K842676	Emit D.a.u. Methadone Assay	Syva Co.	DJR	Class II	1984-09-26
K842675	Emit D.a.u. Barbiturate Assay	Syva Co.	DIS	Class II	1984-09-26
K842674	Emit D.a.u. Amphetamine Assay	Syva Co.	DKZ	Class II	1984-09-26
K842627	C-Section Tray	DeRoyal Industries, Inc.	KDD	Class I	1984-09-26
K842586	Phenytoin Kit Fluorescence Polarization	Windsor Laboratories, Inc.	LGR	Class II	1984-09-26
K842585	Theophylline Kit Fluorescence Polariza-	Windsor Laboratories, Inc.	LER	Class II	1984-09-26
K843421	Emit 700 Cannabinoid Assay	Syva Co.	LDJ	Class II	1984-09-25
K843312	Auto Suture Surgiclip Dispos. Clip Appl	United States Surgical, A Division of Tyco Healthc			1984-09-25
K843136	Brimfield Cannulated Grasping Hooks	Brimfield Scientific Instruments	GDG	Class I	1984-09-25
K843125	Perry Dermaguard Surgical Gloves	Perry, Div.	KGO	Class I	1984-09-25
K842962	Lorraine Dsl Labor & Delivery Bed	Pulley-Kellam Co., Inc.	KNC	Class II	1984-09-25
K842897	Medical Diag. Ultrasound Instr. 77065	Hewlett-Packard Co.	IYO	Class II	1984-09-25
K842766	Crystal Medical Milk Collection Kit	Crystal Medical Products, Inc.	HGX	Class II	1984-09-25
K842714	EEG-4300 W/optinal Access. EEG 4314 &	Nihon Kohden America Inc	GWQ	Class II	1984-09-25
K842695	T.o.d. Plate Sys Sterile	Kirschner Medical Corp.	KTT	Class II	1984-09-25
K842681	T.o.d. Plate System	Kirschner Medical Corp.	KTT	Class II	1984-09-25
K842574	The Clinician	Solidstate Systems Corp.	GEI	Class II	1984-09-25
K842498	Daniell Dbl Puncture Laser Laparoscopy	Laser Spectrum, Inc.	HET	Class II	1984-09-25
K843476	Pharma-Plast Smooth Bore Connectors	Zimmar Consulting, Ltd.	GAZ	Class II	1984-09-24
K843394	Lifeline Tle 484-02	Intermedics, Inc.	DTB	Class III	1984-09-24
K843393	Lifeline Tle 476-04	Intermedics, Inc.	DTB	Class III	1984-09-24
K842999	Veni-Shield	U.S. Mfg. & Management, Inc.	KMK	Class I	1984-09-24