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 2823 of 3529

510(k) clearances, page 2823 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K864597	Gen-Probe Rapid Diagnostic System for Mycobacteria	Hologic, Inc.	LQF	Class I	1987-04-20
K864006	Legionella Pneumophila Ser. 1 Antigen Latex Test	Medical Diagnostic Technologies, Inc.	LHL	Class II	1987-04-20
K870975	Modified Castle Powerclave	Castle Co.	FLE	Class II	1987-04-17
K870705	Thermal Coagulator	Microvasive	KNS	Class II	1987-04-17
K870702	Adg Patellar Component	Buckman Co., Inc.	JWH	Class II	1987-04-17
K870680	Optical Console(tm) and Optical Catheter(tm)	MEDLINE INDUSTRIES, LP - Northfield	FET	Class II	1987-04-17
K870577	E-Z Loop	John F. Greer Co., Inc.	EXB	Class I	1987-04-17
K870444	Homepro II Volumetric Infusion Pump	American Edwards Laboratories	FRN	Class II	1987-04-17
K870165	Foley Catheter	Acorn Medical Products	KOD	Class II	1987-04-17
K865029	Continu-Flo Solution Admin. Set W/in-Line Filter	Travenol Laboratories, S.A.	FPB	Class II	1987-04-17
K864683	Neonatal Feeding Kit	Salt Creek Medical Technologies	KNT	Class II	1987-04-17
K871365	Capsulectomer Cystotome	Noetix, Inc.	HNY	Class I	1987-04-16
K870956	Omron Digital Fever Thermometer Model Mc-7	Omron Electronics, Inc.	FLL	Class II	1987-04-16
K870590	Curette, Periodontal, Columbia University	Military Engineering, Inc.	EMS	Class I	1987-04-16
K870337	Audiometer	Bio-Logic Systems Corp.	ETW	Class II	1987-04-16
K870220	Lem Spectacle Frames Different Colors and Designs	Lem SRL.	HQZ	Class I	1987-04-16
K870219	Lem Sunglasses & Frames Diff. Colors and Designs	Lem SRL.	HQY	Class I	1987-04-16
K870192	Disposable Syringe Tuberculin W/needle	Can-Am Surgical Corp.	FMF	Class II	1987-04-16
K870191	Disposable Syringe with Needle	Can-Am Surgical Corp.	FMF	Class II	1987-04-16
K870190	Disposable Syringe W/o Needle	Can-Am Surgical Corp.	FMF	Class II	1987-04-16
K870178	Sunglasses and Sunglass Frames Various Colors	Polinelli S.r.l.	HQY	Class I	1987-04-16
K871393	Dr Flosser, Flossing Aid/floss Holding Device	Flossrite Corp.	JES	Class I	1987-04-15
K871392	Dr Flosser Refill	Flossrite Corp.	JES	Class I	1987-04-15
K871315	Oral Aspirator	Endovations	DYN	Class I	1987-04-15
K871312	Fibreflex	Biomedical Composites, Ltd.	EBI	Class II	1987-04-15
K871296	T.e.d.(tm) Traction Device	The Kendal Co.	KQZ	Class I	1987-04-15
K871288	Gdc 1830 Casting Alloy	Deringer-Ney, Inc.	EJS	Class II	1987-04-15
K871287	Orthopedic Drill Guide	Mizuho Orthopedic Systems Inc	HSZ	Class I	1987-04-15
K871283	Cyanmethemoglobin Standard	U. S. Diagnostics, Inc.	KRZ	Class II	1987-04-15
K871200	Cui Nasal Septum Button	Cox-Uphuff Intl.	LFB	Unclassified	1987-04-15
K870766	Prosthesis Wire	Treace Medical, Inc.	ETB	Class II	1987-04-15
K870519	Subcutaneously Implanted Drug Delivery Depot	Norfolk Medical Products, Inc.	LJT	Class II	1987-04-15
K870409	Chromagen Test for Group a Strep	Diversified Diagnostic Industries	JTO	Class I	1987-04-15
K870260	Hickman Titanium Subcutaneous Port	C.R. Bard Inc	LJT	Class II	1987-04-15
K864732	Gradtech Syringe System	Gradtech	EGM	Class II	1987-04-15
K864492	Swanson Titanium Great Toe Implant	Dow Corning Wright	KWD	Class II	1987-04-15
K864491	Swanson Titanium Carpal Lunate Implant	Dow Corning Wright	KWN	Class II	1987-04-15
K864490	Swanson Titanium Carpal Scaphoid Implant	Dow Corning Wright	KWO	Class II	1987-04-15
K864489	Swanson Titanium Trapezium Implant	Dow Corning Wright	KYI	Class II	1987-04-15
K864488	Swanson Titanium Condylar Implant	Dow Corning Wright	KYI	Class II	1987-04-15
K871357	Mcbride Agar, Modified	BD Becton Dickinson Vacutainer Systems Preanalytic	JSJ	Class I	1987-04-14
K871324	Du Pont Stericell Cell Culture System	E.I. Dupont de Nemours & Co., Inc.	KJA	Class I	1987-04-14
K871306	Emit Carbamazepine Assay	Syva Co.	KLT	Class II	1987-04-14
K871121	Protect T.m.	Pro-Lab, Inc.	JTR	Class I	1987-04-14
K871065	Chlamydia & Viral Transport Medium	R. Kent Richards, Inc.	JSM	Class I	1987-04-14
K870966	Total Ige Mastick	Mast Immunosystems	DHB	Class II	1987-04-14
K870864	Culturette Brand Cdt Clostridium Difficile Test	Marion Laboratories, Inc.	LLH	Class I	1987-04-14
K870860	Chempro 1000(Tm)	Arden Medical Systems, Inc.	GKF	Class II	1987-04-14
K870752	Seralyzer Ldh/total Bilirubin/triglycerides Strips	Miles Laboratories, Inc.	CFJ	Class II	1987-04-14
K870736	Dart Theophylline Reagent System	Coulter Electronics, Inc.	KLS	Class II	1987-04-14