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 2026-10-08, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,902 of the 176,299 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	2,502

176,299 records, page 3348 of 3526

510(k) clearances, page 3348 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K801166	Pet-Scope II Model Dis-1611	Diagnostic Information, Inc.	JAA	Class II	1980-06-26
K801049	V.i.b.e. Video Interface Biofeedback Equ	Nebulae Productions	HCC	Class II	1980-06-26
K801042	Silastic Brand Percutaneous Skin Expande	Dow Corning Corp. Healthcare Industries Materials	LCJ	Unclassified	1980-06-26
K800565	Hessler Colon Therapy Device	Hessler Mfg. Co.	KPL	Class II	1980-06-26
K800069	Medtronic Models 5966/5967, Etc.	Medtronic, Inc.	DXY	Class III	1980-06-26
K801367	Model 336B Hearing Aid	Communications, Inc.	ESD	Class I	1980-06-20
K801343	B-D Filter Needle	BD Becton Dickinson Vacutainer Systems Preanalytic	FPB	Class II	1980-06-20
K801332	Ampco Skin Scrub Trays	Associated Medical Products Co.	FRG	Class II	1980-06-20
K801310	The Magtec System	Valley Forge Scientific Corp.			1980-06-20
K801309	Ritter Sterilizer	Sybron Corp.	FLE	Class II	1980-06-20
K801308	Fiax Test Kit for Tobramycin Quantita	Intl. Diagnostic Technology	LCR	Class II	1980-06-20
K801301	Golden Thermal Rhinoplasty Cast Bandage	Auric, Inc.	ILO	Class II	1980-06-20
K801292	Surgical Instruments	William Skidmore & Co., Ltd.			1980-06-20
K801281	J.t. Baker Immunoglobulin G Nephelometri	J.T. Baker Chemical Co.	DEW	Class II	1980-06-20
K801276	Dupont Prep Appli. for Phenobarbital,	E.I. Dupont de Nemours & Co., Inc.	DKH	Class II	1980-06-20
K801263	Nuclear Enterprises 1612 Multi-Well	Nuclear Ent., Ltd.	JJJ	Class I	1980-06-20
K801245	Atomlight (Liquid Scintillation Solution	New England Nuclear	JJJ	Class I	1980-06-20
K801244	Roche Hcg Standards	Hoffmann-La Roche, Inc.	JHI	Class II	1980-06-20
K801242	Cobas Reagent for Alkaline Phosphatase	Roche Analytical Instruments, Inc.	CJE	Class II	1980-06-20
K801235	Reigning Artificial Teeth/polycarb.resin	Oki Shiks USA, Ltd.	ELM	Class II	1980-06-20
K801226	Triglycerides for Sma and Aaii	Reagents Applications, Inc.	CDT	Class I	1980-06-20
K801207	Emit Valproic Acid Assay	Syva Co.	LEG	Class II	1980-06-20
K801202	Digoxin Radioimmunoassay Kit	Technia Diagnostics, Ltd.	LCS	Class II	1980-06-20
K801159	Strepto-Sec Tm	Organon LLC	GTZ	Class I	1980-06-20
K801154	Proximate*(ils) Disp. Intraluminal Stap.	Ethicon, Inc	GDW	Class II	1980-06-20
K801136	D300 Dome	Gics Pharmaceuticals	DRS	Class II	1980-06-20
K801118	Cobas Reagent for Ast (Sgot)	Roche Analytical Instruments, Inc.	CIT	Class II	1980-06-20
K801043	E-Vax Chest Drainage System	Cardio Surgical Concepts, Inc.	JCX	Class II	1980-06-20
K801014	Stanbio Acetaminophen Test Set #0850	Stanbio Laboratory	LDP	Class II	1980-06-20
K800946	Urinary Catheter Sampling Kit	Sage Products LLC	KDT	Class I	1980-06-20
K800911	A-Gent Thyrozyme Uptake Inhibitor Assay	Abbott Medical	KHQ	Class II	1980-06-20
K800890	Lineberger External Male Catheter	Lineberger External Catheter Co.	KNX	Class II	1980-06-20
K800797	Macro-Vue Rubella Card Test	BD Becton Dickinson Vacutainer Systems Preanalytic	GOL	Class II	1980-06-20
K801383	Eca Cream Reformulation	Vanaray Laboratories, Inc.	GYB	Class II	1980-06-17
K801364	Ao Stylet Laryngoscope Model Sls	American Optical Corp.	CAL	Class I	1980-06-17
K801312	The Protectors	Cooper Medical Devices Corp.			1980-06-17
K801311	Burron Multi-Ad Syringe Cap	Burron Medical Products, Inc.	FMF	Class II	1980-06-17
K801304	Camloc Syringe Biopsy Kit	Johannah Medical Services, Inc.	GEE	Class I	1980-06-17
K801293	Acoustic Impedance Meter, Model Ta-4D	Teledyne Avionics Div. of Teledyne	ETY	Class II	1980-06-17
K801272	Tecnol Quick Release Limb Holder	Tecnol New Jersey Wound Care, Inc.	FMQ	Class I	1980-06-17
K801250	Hydra Tred Dc	Medichanics, Inc.	IOG	Class I	1980-06-17
K801232	Jackson Lacrimal Intubation Set	Storz Instrument Co.	HNL	Class I	1980-06-17
K801230	Hearing Aid, Unitron Model C4-55	Unitron Industries, Inc.	ESD	Class I	1980-06-17
K801225	Den-Mat Polishing Paste	Den-Mat Corp.	EJR	Class I	1980-06-17
K801210	Biostator Printer/plotter	Miles Laboratories, Inc.	JQP	Class I	1980-06-17
K801206	Emit Valproic Acid Control	Syva Co.	LAS	Class I	1980-06-17
K801133	Centrifichem Hdl Cholesterol	Union Carbide Corp.	LBS	Class I	1980-06-17
K801124	Nylon Ligating Clip	Ethicon, Inc	FZP	Class II	1980-06-17
K801116	Cobas Reagent for Bun	Roche Analytical Instruments, Inc.	CDQ	Class II	1980-06-17
K801102	Compalor-Oral Surgery Model	Narco Mckesson Co.	BSZ	Class II	1980-06-17