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 2026-11-05, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,132 of the 176,529 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	2,732

176,529 records, page 2302 of 3531

510(k) clearances, page 2302 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K922202	K-Stim Clear	Katecho LLC	GZJ	Class II	1993-05-17
K921770	Electrosurgical Units Esu 100L, 100 L M/m & E M/m	Elmed, Inc.	GEI	Class II	1993-05-17
K921295	Intravenous Catheters Modifications	Critikon Company, LLC	FGO	Class II	1993-05-17
K920347	Top-X 650Hf Radiographic X-Ray	Control-X, Inc.	KPR	Class II	1993-05-17
K915385	Ppc Hip Stem Component	Implantology Corp.	JDG	Class II	1993-05-17
K931311	Thyroid Peroxidase Auto Antibodies(tpo) Immun Kit	Nichols Institute	JZO	Class II	1993-05-14
K930827	Bard Stabilizing Cannula	C.R. Bard Inc	FAJ	Class II	1993-05-14
K930770	Medtronic Minix & Minix St Pulse Generators	Medtronic, Inc.	DXY	Class III	1993-05-14
K930556	Night Urinary Drainage Bedside Bag	Ezmt Valve Co., Inc.	EYZ	Class I	1993-05-14
K930157	Test Thrombin	Behring Diagnostics, Inc.	GJA	Class II	1993-05-14
K925044	Ventrex Allergen Disc	Ventrex, Inc.	DHB	Class II	1993-05-14
K924859	Aia-Pack Ige Calibration Verification Test Set	Tosoh Medics, Inc.	JJX	Class I	1993-05-14
K923868	Ccs Maestro II Series 200 Cardiac Pacemaker	Cardiac Control Systems, Inc.	DXY	Class III	1993-05-14
K921138	Nicolet Ultrasom Acquisition Station	Nicolet Instrument Corp.	GWQ	Class II	1993-05-14
K931603	Millipore Rt-100 Aerosol Retention Filter	Sterimatics Co.	CAF	Class II	1993-05-13
K931276	Mist Ratcheted Forceps for Laparoscopic/endoscopic	Minimally Invasive Surgical Technologies, Inc.	GCJ	Class II	1993-05-13
K931147	Prospect(tm) Giardia Rapid Assay, Modification	Alexon, Inc.	MHI	Class II	1993-05-13
K930866	Rascal II	GE Healthcare	CCK	Class II	1993-05-13
K930865	Staodyn Maxima III	Staodyne, Inc.	GZJ	Class II	1993-05-13
K930798	Omron Oscillometric Digital Blood Pressure Monit.	Omron Healthcare Co., Ltd.	DXN	Class II	1993-05-13
K926393	Vidas Thyroxine (T4) Assay (T4)	Biomerieux Vitek, Inc.	KLI	Class II	1993-05-13
K925537	Powder-Free Latex Examination Gloves	Safetytech Sdn. Bhd.	LYY	Class I	1993-05-13
K925422	Bird 1000 Pv Portable Ventilator	Bird Products Corp.	CBC	Class II	1993-05-13
K924910	System 7500 Nibp/sa02	Advanced Medical Instruments, Inc.	DXN	Class II	1993-05-13
K923875	Sidekick 50 Plus and Sidekick 100 Plus	Halyard Health	FRN	Class II	1993-05-13
K923653	Needleless Injection Cannula	Arrow Intl., Inc.	LJS	Class II	1993-05-13
K923066	Flo-Gard 2100 - 2M8281m	Baxter Healthcare Corporation	LZH	Class II	1993-05-13
K922439	Latex Examination Gloves	Transcorp	LYY	Class I	1993-05-13
K921891	Silent Scan	Avotec, Inc.	LNH	Class II	1993-05-13
K921457	Irrigation Pumps and Tubing and Suction Tubing	American Surgical Instruments Corp.	GCJ	Class II	1993-05-13
K920178	Cardiotomy Reservoir W/20 Micron Filiter	Lifestream Int'L, Inc.	DTN	Class II	1993-05-13
K912724	Guidor(tm)	Procordia Oratech AB	NPK	Class II	1993-05-13
K931598	Biosite Triage Panel for Drugs of Abuse(50ng/ml)	Biosite Incorporated	LDJ	Class II	1993-05-12
K931414	Catalase Reagent	Hardy Diagnostics	JTO	Class I	1993-05-12
K931181	Vesitec Suture Passer	Vesitec Medical, Inc.	KOA	Class I	1993-05-12
K931139	Doculment(r) Chem VI Calibration Verif Test Set	Casco Standards	JJY	Class I	1993-05-12
K931069	Pasco Mic and Mic/id Panels	Pasco Laboratories, Inc.	JWY	Class II	1993-05-12
K930693	Oxystrip	Hardy Diagnostics	JTO	Class I	1993-05-12
K930551	Kendall Universal Extension Set	Kendall Healthcare Products Co. Div.Of Tyco Health	GBX	Class I	1993-05-12
K930489	Amylase Method/dimension(r) Clinical Chemistry Sys	E.I. Dupont de Nemours & Co., Inc.	JJE	Class I	1993-05-12
K930401	Aluminum Foil	Gam Industries, Inc.	MGP	Unclassified	1993-05-12
K926207	Medtrax Packing Strip	Medtrax Industries, Inc.	FRO	Unclassified	1993-05-12
K926202	Clearsite Sterile Wound Dressing, Ndm Wound Dressi	Ndm Corp.	NAE	Class I	1993-05-12
K925914	Pre-Tied Loop Suture Cannula	Ethicon, Inc	GCJ	Class II	1993-05-12
K925841	Hydrasorb Joyce Sponge	Avitar, Inc.	NAC	Class I	1993-05-12
K925534	Full/semi Electric Home Care Bed	Ivacare Corp.	FNL	Class II	1993-05-12
K925426	Rizzo Nasal Implant	Implantech Associates Inc	FZE	Class II	1993-05-12
K925348	Implex H-110 and H-120 Cemented Hip Stem System	Implex Corp.	JDI	Class II	1993-05-12
K924705	Force Sensing Array	Force Sensing Systems	JFC	Class I	1993-05-12
K924512	Lido V-Tak	Loredan Biomedical, Inc.	LXJ	Class II	1993-05-12