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 3107 of 3528

510(k) clearances, page 3107 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K833565	Comfeel Paste	MEDLINE INDUSTRIES, LP - Northfield	EXB	Class I	1984-01-30
K833533	Laser Photocoagulator 1520-a & K	Britt Corp., Inc.	HQF	Class II	1984-01-30
K833519	Pulse Generator Model 688	Burditt & Calkins-Siemens-Elema	DXY	Class III	1984-01-30
K833489	Dpc Gastrin Kit	Siemens Healthcare Diagnostics Inc.	CGC	Class I	1984-01-30
K833421	Programmable Stimulator 2352	Medtronic, Inc.	JOQ	Class II	1984-01-30
K833142	Antibody to Intrinsic Factor Radioassay	BD Becton Dickinson Vacutainer Systems Preanalytic	CDD	Class II	1984-01-30
K832991	Hypal Adhesive Tape	Smith & Nephew, Inc.	KQX	Class I	1984-01-30
K832876	Lifepak 7P	Physio Control, Inc.	DRO	Class II	1984-01-30
K832731	Breast & Body Health System 2000	American Thermal Instruments, LLC	KXZ	Class III	1984-01-30
K832703	Argon Laser Sys-Model 5000	Cooper Medical, SRL	HQE	Class II	1984-01-30
K832628	Vygon Thoracic Drainage-Various #'S	Exco, Inc.	KDD	Class I	1984-01-30
K832316	Ophthalmic Argon Laser #700A	Laser Industries, Ltd.	HQF	Class II	1984-01-30
K832089	Model 150K Laser Coagulator	Lasertek Oy	HQF	Class II	1984-01-30
K830635	Sterile Disposable Surgical Gloves	Intermarket Latex, Inc.			1984-01-30
K840378	Adjust-a-Temp Extra Fine Tip	Suncoast Medical Manufacturers, Inc.			1984-01-27
K840374	Surg-a-Stat Fine Tip	Suncoast Medical Manufacturers, Inc.			1984-01-27
K840125	Iura Universal Wheelchair/stretcher-	Trade West, Inc.	FPO	Class II	1984-01-27
K840124	Iura Universal Hospital Stretcher-Hs-13	Trade West, Inc.	FPO	Class II	1984-01-27
K840122	Iura Ambulance Stretcher Ias-1	Trade West, Inc.	FPO	Class II	1984-01-27
K834542	H.r. Jakobi Surg. Instru. Sect. 48	Imm Enterprises, Ltd.	HTD	Class I	1984-01-27
K834541	H.r. Jakobi Surg. Instruments #9-Sec.48	Imm Enterprises, Ltd.	GDX	Class I	1984-01-27
K834509	Acetamide Agar Slants	BD Becton Dickinson Vacutainer Systems Preanalytic	JSH	Class I	1984-01-27
K834491	Uva Suntanning Lamps	D.P.R.M., Inc.	FTC	Class II	1984-01-27
K834352	Adult Vent Catheter	Dlp, Inc.	DRA	Class II	1984-01-27
K834324	Tsa	Hardy Media	JSG	Class I	1984-01-27
K834297	Propper Seracult	Propper Mfg Co Inc	KHE	Class II	1984-01-27
K834220	Hybrid Peripheral Dilation Catheter	American Edwards Laboratories	LIT	Class II	1984-01-27
K834198	Jakobi Surg. Instruments #12 40/41	Imm Enterprises, Ltd.	FZO	Class I	1984-01-27
K834197	Jakobi Surg. Instr- #11 38/39/45/46/67	Imm Enterprises, Ltd.	EMF	Class I	1984-01-27
K834196	Jakobi Surg. Instruments #11 20/25/27/37	Imm Enterprises, Ltd.	GAD	Class I	1984-01-27
K834195	Jakobi Surg. Instruments #11 11/13/14	Imm Enterprises, Ltd.	GES	Class I	1984-01-27
K834194	Jakobi Surg. Instruments #1 19/10/26	Imm Enterprises, Ltd.	GES	Class I	1984-01-27
K834186	Jakobi Surg. Instruments #11	Imm Enterprises, Ltd.			1984-01-27
K834185	Jakobi Surg. Instruments #11 14/45	Imm Enterprises, Ltd.	HTD	Class I	1984-01-27
K834184	H.r. Jakobi Surg. Instruments #11 38/67	Imm Enterprises, Ltd.	EMF	Class I	1984-01-27
K834183	H.r. Jakobi Surg. Instruments #11 25/39	Imm Enterprises, Ltd.	HTD	Class I	1984-01-27
K834182	H.r. Jakobi Surg. Instruments #11 27/37	Imm Enterprises, Ltd.	GES	Class I	1984-01-27
K834181	H.r. Jakobi Surg. Instruments #11 16/46	Imm Enterprises, Ltd.	GAD	Class I	1984-01-27
K834180	H.r. Jakobi Surg. Instruments #11 13/20	Imm Enterprises, Ltd.	HTD	Class I	1984-01-27
K834179	H.r. Jakobi Surg. Instruments #9 48	Imm Enterprises, Ltd.	BTO	Class II	1984-01-27
K834176	H.r. Jakobi Surg. Instruments 40/41	Imm Enterprises, Ltd.	GEG	Class I	1984-01-27
K834175	Op-Con Surg. Instruments #11	Imm Enterprises, Ltd.	HRQ	Class I	1984-01-27
K834138	Hypo Suture	Medical Design & Manufacturing Corp.	GAG	Class II	1984-01-27
K834095	Biopsy Forceps	Micro Vasive, Inc.	GEN	Class I	1984-01-27
K834069	Arthroscan Video System	Concept, Inc.	FWF	Class I	1984-01-27
K833970	Micro-Structured Hs2p Hip Stems	Osteonics Corp.	LWJ	Class II	1984-01-27
K833902	Vasoscan	Sonicaid, Inc.	JOP	Class II	1984-01-27
K833882	Instrument Cabinet	JEDMED Instrument Company	ETF	Class I	1984-01-27
K833867	Parema K Band Non-Sterile	Mark One Healthcare Products	EFQ	Unclassified	1984-01-27
K833731	Breathable Overwray Bandage Non-Elas	American Medical Disposable, Inc.	KGX	Class I	1984-01-27