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 2026-10-22, 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 2931 of 3529

510(k) clearances, page 2931 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K855030	Champy Bone Plates & Bone Screws	Advanced Biosearch Assn.	JEY	Class II	1986-01-30
K855005	Fiber Mesh	Fiber Mesh, Inc.	DZE	Class II	1986-01-30
K854957	Austenal Dental Composite Resin	Austenal Dental, Inc.	EBD	Class II	1986-01-30
K854940	Tips and Pads, Cane,crutch and Walker	Healthtech Industries, Inc.	FNJ	Class I	1986-01-30
K854932	Ecumol Ultraviolet Face Tanning Units	Mottek Intl. Corp.	FTC	Class II	1986-01-30
K854882	Protec/visible Light-Cured Sealant/dental Restorat	Lee Pharmaceuticals	EBC	Class II	1986-01-30
K854878	H40 Base Metal Alloy	Jeneric Ind.	EJH	Class II	1986-01-30
K854855	Proof Alginate Impression Material	Sybron Corp.	ELW	Class II	1986-01-30
K854707	Suntainning Booth	David Connell	FTC	Class II	1986-01-30
K854633	Jackson Rare Earth Magnetic Attachment	Solid State Innovations, Inc.	EGG	Class I	1986-01-30
K854594	Phoenix U.v.a. Suntan Beds	Phoenix U.V.A., Ltd.	FTC	Class II	1986-01-30
K854151	Homecare Clinics Infraheat #230	Nelkin/Piper Intl.	ILY	Class II	1986-01-30
K853885	Model RF-TENS-4 Transcutaneous Elec. Nerve Stimula	Uniking Intl. Corp.	GZJ	Class II	1986-01-30
K852862	Corneo-Gage Two	Sonogage, Inc.	IYO	Class II	1986-01-30
K852648	Starport Model H3300aa	General Electric Co.	IYX	Class I	1986-01-30
K852525	Satalec Piezotec	Spelna, Inc.	ELC	Class II	1986-01-30
K855028	Total Cholesterol Reagent Set	Sterling Diagnostics, Inc.	CHH	Class I	1986-01-28
K854958	Hcg Ria Test System	Monobind, Inc.	JHI	Class II	1986-01-28
K854952	Cirrus Nebulizer-Deluxe Kit	Dhd Medical Products Div. Diemolding Corp.	CCQ	Class I	1986-01-28
K854805	Allegro Prolactin Immunoassay System	Nichols Institute Diagnostics	CFT	Class I	1986-01-28
K854675	Dsl Androstenedione Ria (Dsl #4200)	Diagnostic Systems Laboratories, Inc.	JLS	Class I	1986-01-28
K854615	Monabrite Chlamydia Trach Culture Confirmation Tes	Serono Diagnostics, Inc.	LKI	Class I	1986-01-28
K854509	Travelpak Model Ac-102	Travomed, Inc.	CAW	Class II	1986-01-28
K854328	Medex X-Ray Table	Philips North America LLC	KXJ	Class II	1986-01-28
K860176	Laryngectomy Tube, Cuffed	Sheridan Catheter Corp.	BTO	Class II	1986-01-27
K860071	Hold-It Framed Adhesive Film	VLV Associates, Inc.	KMK	Class I	1986-01-27
K860068	Foot Pedal Cover	O.R. Concepts, Inc.			1986-01-27
K860067	Microscope Column Drape	O.R. Concepts, Inc.			1986-01-27
K854658	Churchill - Hbc Vented Ball Check IV Set	Churchill Corp.	FPA	Class II	1986-01-27
K854543	Pulse Lavage	Tava Surgical Instruments	FQH	Class II	1986-01-27
K854115	Custo Port 24-H ECG Ambulatory Recorder	Versacor, Inc.	DSI	Class II	1986-01-27
K853629	Bard Harvard Chronofusor Time-Dose Syringe Infusio	C.R. Bard Inc	FRN	Class II	1986-01-27
K853317	Fortec Mi-305 & 306 Digital Thermometer	Nam Tai, Ltd.	FLL	Class II	1986-01-27
K860112	Total Lipids Reagent Set	Technostics Intl.	CFD	Class I	1986-01-24
K860095	Digikit Nonpneumatic Tourniquet	Orthofab, Inc.	KCY	Class I	1986-01-24
K860088	Pl Exam Light	Burton Medical Products Corp.	FTD	Class II	1986-01-24
K860080	Olympus Au 5000 Chemistry Analyzer System	Olympus Corp.	JJE	Class I	1986-01-24
K860041	Strep D Fluor	Bio Spec, Inc.	GTP	Class I	1986-01-24
K860020	Minor Surgery Light Model 2112	Adel Medical, Ltd.	FSS	Class II	1986-01-24
K855206	Cefaclor 30 Mcg Sensitivity Discs	Difco Laboratories, Inc.	JTN	Class II	1986-01-24
K855160	Care IV Burn Pad, Catalog #'S Bp2334,bp3472	Howard Associates, Inc.			1986-01-24
K855141	Angiomed Fine Needles and Needle Set	Angiomed U.S., Inc.	GAA	Class I	1986-01-24
K855132	Shave Prep Tray	Dynarex Corp.	MDM	Class I	1986-01-24
K855104	Angiomed Skin Fascia Knife	Angiomed U.S., Inc.	GES	Class I	1986-01-24
K855039	Mediflex Injection Cap	Mediflex Intl.	GCE	Class I	1986-01-24
K855033	T-3 Uptake/riassay	Ria Diagnostics	KHQ	Class II	1986-01-24
K855020	Medical Dynamics Ccd Solid State Video Camera 5930	MEDLINE INDUSTRIES, LP - Northfield	FWB	Class I	1986-01-24
K854988	Ky-M280u Surgical Camera	Us Jvc Corp.	FWC	Class I	1986-01-24
K854922	Amsco Polaris Sl	Amsco Co.	FSY	Class II	1986-01-24
K854916	Pilling Hemostatic Clip Applier Forceps	Pilling Co.	GEN	Class I	1986-01-24