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 1443 of 3531

510(k) clearances, page 1443 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K031975	Imsure	Prodigm, Inc.	IYE	Class II	2003-08-29
K031730	36Mm Orthinox V40 Femoral Head Components	Howmedica Osteonics Corp	JDI	Class II	2003-08-29
K031710	Olympus Ultrasonic Surgical System	AOMORI OLYMPUS CO., Ltd. Kuroishi Site	LFL	Unclassified	2003-08-29
K031700	Medtronic Resting Heart System, Model Aar1000 and 711	Medtronic Perfusion Systems	DTN	Class II	2003-08-29
K031697	Dr. Scholl's Freeze Away Wart Remover, Model 40226	Schering-Plough Healthcare Products, Inc.	GEH	Class II	2003-08-29
K031694	Modification to EEG Monitor with Bis, Model a-2000	Aspect Medical Systems, Inc.	OLW	Class II	2003-08-29
K031634	Omnipro I'mrt	Wellhofer Dosimetrie	IYE	Class II	2003-08-29
K030742	Polarcath Peripheral Balloon Catheter System	Cryo Vascular Systems, Inc.	LIT	Class II	2003-08-29
K030441	Sydney Ivf Blastocyst Cryopreservation Kit and Sydney Ivf Blastocyst Thaw Kit	Cook Ob/Gyn	MQL	Class II	2003-08-29
K030379	Aplab, Model 801D0030	Sector Medical Corp.	MNR	Class II	2003-08-29
K030237	Kapp Custom Radial Head Elbow Implant	Kapp Surgical GmbH	KWI	Class II	2003-08-29
K030066	Cal/rad Mark Vi/vdc-505 Dose Calibrator, Model 34-165	Nuclear Associates	KPT	Class II	2003-08-29
K024313	Modification to Universal Multiaxis (Unimax) Pedicle Screw System	Pisharodi Surgicals, Inc.	MNI	Class II	2003-08-29
K020424	V Set	Hennig Enterprises Europe S.r.l.	FPA	Class II	2003-08-29
K020419	V Set	P.T. Greenleaf	FPA	Class II	2003-08-29
K032453	Roche Combitrol and Autotrol Plus B Multi Analyte Control	Bionostics, Inc.	JJY	Class I	2003-08-28
K032432	Busse Hospital Disposables Spinal Manometer	Busse Hospital Disposables	FMJ	Class II	2003-08-28
K032325	Jobst Travel Socks	BSN-Jobst GmbH	DWL	Class II	2003-08-28
K032294	Non-Sterile, Powder Free Orange Latex Examination Gloves W/ or without Orange/vanilla Scenting Plus a Protein Labeling	Sgmp Co., Ltd.	LYY	Class I	2003-08-28
K032293	Non-Sterile, Powder Free Green Latex Examination Gloves with or without Sour Apple or Peppermint Scenting Plus a Protein	Sgmp Co., Ltd.	LYY	Class I	2003-08-28
K031712	Inion Otps Biodegradable Pin	Inion Oy	HTY	Class II	2003-08-28
K032498	Dental Implant Coping (Prosthetic Accessories to the Iti Dental Implant System)	Straumann USA, LLC	NHA	Class II	2003-08-27
K032360	Modification to Boston Scientific Express Biliary Ld Premounted Stent System and Express Biliary Ld Unmounted Stent	Boston Scientific Corporation	FGE	Class II	2003-08-27
K032276	Click Holter	Remco Italia S.p.A.	MWJ	Class II	2003-08-27
K032070	Elcacam	A-dec, Inc.	EIA	Class I	2003-08-27
K032069	Workhorse II Percutaneous Transluminal Angioplasty Balloon Catheter	Boston Scientific Corporation	DQY	Class II	2003-08-27
K032041	Distal Perfusion Catheter (1.5 Cm) and (2.5Cm)	LeMaitre Vascular Inc.	DWF	Class II	2003-08-27
K032026	Lcd Monitor, Radiforce G11, G31, G51	Eizo Nanao Corporation	LLZ	Class II	2003-08-27
K031984	Bd Phoenix Automated Microbiology System-Ticarcillin-1-128 Ug/ml	Becton Dickinson & Co	LON	Class II	2003-08-27
K031748	Vitalcare Sterilewater and 0.9% Sodium Chloride Pre-Filled 10Cc/30cc Syringes	Vitalcare Group, Inc.	EZL	Class II	2003-08-27
K031665	Iris Medical Oculight Gl/glx Laser Systems	Iridex Corporation	HQF	Class II	2003-08-27
K031187	Heartstart Mrx, Model M3535a	Philips North America LLC	MKJ	Class III	2003-08-27
K031043	D-10 Hemoglobin A1c	Bio-Rad Laboratories Inc.	LCP	Class II	2003-08-27
K030898	Mobile Battery Service Station (Mbss)	Ad Elektronik GmbH	MKJ	Class III	2003-08-27
K030693	Kentex Disposable Vaginal Speculum	Kentron Health Care, Inc.	HIB	Class II	2003-08-27
K030586	Micropeak	Micro Direct, Inc.	BZH	Class II	2003-08-27
K030525	Custom Products Ivf Workstation Type Wkst-2436, Wkst-2448, Wkst-2460, Wkst-2472 and Wkst-24*72D Plus Accessories	Mid-Atlantic Diagnostics, Inc.	MQG	Class II	2003-08-27
K030381	Portex Blue Line Ultra Tracheostomy Tube (Cuffed) with Reusable Inner Cannula	Abbott Medical	BTO	Class II	2003-08-27
K023617	Dri Methadone Metabolite Enzyme Immunoassay	Microgenics Corporation	DJR	Class II	2003-08-27
K021161	Tso3 Ozone Chemical Indicator	Technologies of Sterilization with Oxone, Tso3, Inc.	JOJ	Class II	2003-08-27
K032376	Angiodynamics Accu-Vu Sizing Angiographic Catheter	Boston Scientific Corporation	DQO	Class II	2003-08-26
K032298	Modification to Outback Catheter	Lumend, Inc.	DQY	Class II	2003-08-26
K032297	Disposable N-Pe Mickrokeratome Blades	Oasis Medical, Inc.	HNO	Class I	2003-08-26
K032272	Disposable Powder Free Vinyl Synthetic Exam Gloves White Color	Est International Corporation	LYZ	Class I	2003-08-26
K032250	Geoform Annuloplasty Ring, Mitral Model 4200	Edwards Lifesciences LLC	KRH	Class II	2003-08-26
K032236	Disposable Powered Vinyl Synthetic Exam Gloves, White Color	Est International Corporation	LYZ	Class I	2003-08-26
K031740	Vsm - Vital Signs Monitor, Model 53000 Series	Welch Allyn Protocol, Inc.	DQA	Class II	2003-08-26
K031678	Hi-Torque Balance Iniversal Guide Wire with Hydrocoat Hydrophilic Coating	Boston Scientific Corporation	DQX	Class II	2003-08-26
K030440	Oasys-Oral Airway System	Mark Abramson, D.D.S., Inc.	LRK	Class II	2003-08-26
K022721	Uropower	Novanta Medical GmbH	EXY	Class II	2003-08-26