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 3206 of 3528

510(k) clearances, page 3206 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K822242	Sanitary/ob Napkins	Hospital Specialty Co.	HHD	Class I	1982-09-09
K822228	Gastro Vage Set for Gastric Lavage	Ackrad Laboratories	KNT	Class II	1982-09-09
K822025	Automatic Splicing Device	E.I. Dupont de Nemours & Co., Inc.	FKX	Class II	1982-09-09
K821524	Chiropratic Infra-Red Crystal Pak	Dr. John D. Reid B.A., D.C.	KYA	Class I	1982-09-08
K822516	Vivonex Mass Gastrastomy Tube	Norwich Eaton Pharmaceuticals, Inc.	KHT	Class I	1982-09-07
K822506	Hearing Aid, Unitron Ue3-D/dn	Unitron Industries, Inc.	ESD	Class I	1982-09-07
K822451	Aurafill* Dental Restorative Bonding Ag.	Johnson & Johnson Professionals, Inc.	KLE	Class II	1982-09-07
K822415	The Ocuplot D	Coherent Medical Division	HPJ	Class II	1982-09-07
K822367	Total	Treace Medical, Inc.	LBN	Class II	1982-09-07
K822348	Tytan Tube Inserter	Treace Medical, Inc.	JYM	Class I	1982-09-07
K822328	Il 301 Transcutaneous Oxygen Monitor	Instrumentation Laboratory Co.	KLK	Class II	1982-09-07
K822218	Narkomed 2A Anesthesia Machine	Draeger, Inc.	BSZ	Class II	1982-09-07
K821910	Anesthesia & Brain Monitor	Datex Division Instrumentarium Corp.	IKN	Class II	1982-09-07
K821735	Tropic Air Heat-Echanger Breathing Aid	Tropic Air	BZE	Class II	1982-09-07
K821656	Duoderm Flexible Hydroactive Dressings	Convatec, A Division of E.R. Squibb & Sons	FRO	Unclassified	1982-09-07
K822443	Naso-Gard Nasogastric Tube Holder	American Pharmaseal Div. Ahsc	KNT	Class II	1982-09-02
K822442	Vast Ventrex Rast Allergen Discs	Ventrex Laboratories, Inc.	DGC	Class II	1982-09-02
K822428	Surgi-Quip Microscope Stand	Surgi-Quip Inc.U	HBN	Class I	1982-09-02
K822426	Mcintyre Microscope Stand	Surgi-Quip Inc.U	HBN	Class I	1982-09-02
K822422	Basic Centrifuge	Biodynamics Corp.	JQC	Class I	1982-09-02
K822366	Tytan Grommet Vent Tube, .040	Treace Medical, Inc.	ETD	Class II	1982-09-02
K822343	B-Hcg	Siemens Healthcare Diagnostics Inc.	JHI	Class II	1982-09-02
K822334	Bilirubin Calibrators	Gilford Diagnostics	JIT	Class II	1982-09-02
K822330	Bactec Diluting Fluid	BD Becton Dickinson Vacutainer Systems Preanalytic	JSD	Class I	1982-09-02
K822329	Antituberculous Drugs (Sire)	BD Becton Dickinson Vacutainer Systems Preanalytic	JTT	Class II	1982-09-02
K822323	Ultrachem Bun-UV, 65080 & 65081	Harleco Diagnostics	CDW	Class II	1982-09-02
K822298	Diagnostic Radioimmunoassay for Quanti	Nuclear Medical Laboratories, Inc.	JFH	Class II	1982-09-02
K822260	Tracheal Dilators	Kelleher Corp.	KCG	Class I	1982-09-02
K822244	Nephrosol	Dialysis Systems, Inc.	KOC	Class II	1982-09-02
K822152	Hcg Beta Ria Kit	Clinetics Corp.	JHI	Class II	1982-09-02
K821851	Control Diagnostics Platelet Control	Immunogenetics	KRY	Class II	1982-09-02
K827889	Kodak Kodaflex Film	Eastman Kodak Company			1982-09-01
K827453	UV Safety Infuser Shield	U.V. Technology, Inc.			1982-09-01
K822317	Argyle Carotid Artery Loop Shunt	Sherwood Medical Co.	DWF	Class II	1982-08-31
K822294	Vpd-261 Defibrillator Monitor	Life Science Instrumentation, Inc.	LDD	Class II	1982-08-31
K822290	Sterile Protective Sleeve W/tough-Borst	Universal Medical Instrument Corp.	DQO	Class II	1982-08-31
K822245	Indeflator	Advanced Cardiovascular Systems, Inc.	LIT	Class II	1982-08-31
K822236	Franklin Quantic 1200	Bruce Franklin, Inc.	DXK	Class II	1982-08-31
K822221	Chiropractic Adjusting Table Model 646	Tri W-G, Inc.	INQ	Class I	1982-08-31
K822215	Nic Optronics Cs-2000	Nicolet Biomedical Instruments	HOX	Class I	1982-08-31
K822212	Motorized Exerciser	W.R. Mccullin	BXB	Class I	1982-08-31
K822113	Inspiraid Va-1 Ventilator	Inspir Aid	CBK	Class II	1982-08-31
K821920	I.c.e. Box	Lhs Industries	IRP	Class II	1982-08-31
K821716	Bard PTFE Vascular Prosthesis	C.R. Bard Inc	DSY	Class II	1982-08-31
K821190	Guide Wire	Advanced Cardiovascular Systems, Inc.	DQX	Class II	1982-08-31
K821109	Trimmore Election Beautifier	Rn Int'L, Inc.	ISA	Class I	1982-08-31
K820635	Pvp Gel Dressing	Johnson & Johnson Professionals, Inc.	FRO	Unclassified	1982-08-31
K822485	Hpf 100,200,300 Capillary Flow Dialyz	Erika, Inc.	FKQ	Class II	1982-08-30
K822433	Gards (Unscented, Menstrual Pad)	Hospital Specialty Co.	HHD	Class I	1982-08-30
K822419	New Crown and Bridge Alloy No. Dw196	Williams Gold Refining Co., Inc.	EJS	Class II	1982-08-30