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 3188 of 3528

510(k) clearances, page 3188 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K823341	Triglycerides Reagent Set Tag-Gk	Sterling Biochemical, Inc.	CDT	Class I	1982-12-22
K823313	In Vitro Gammacoat B-Hcg Radio. Test	Clinical Assays, Inc.	JHI	Class II	1982-12-22
K823304	Riaset Prolactin Ria Kit	Immulok, Inc.	CFT	Class I	1982-12-22
K823281	Model Rm 6000, 6100,6200 Polygraph	Nihon Kohden America Inc	DPS	Class II	1982-12-22
K823271	Disposable Adult Vo. Ventilator Circuit	Intec Medical, Inc.	BZO	Class I	1982-12-22
K822000	Extracorporeal Blood Gas System	Cardiovascular Devices, Inc.	DTY	Class II	1982-12-22
K821983	Titan Gel Ldh Isoenzyme Kit	Helena Laboratories, Corp.	CEX	Class II	1982-12-22
K821951	Datascope Model 83 Iabp System	Datascope Corp.	DSP	Class II	1982-12-21
K828545	Maxicamera 500A Small Field Imaging System	General Electric Co.			1982-12-20
K828544	Maxicamera 400Zs	General Electric Co.			1982-12-20
K822913	Uric Acid Reagent	Ac Biochemical Laboratories, Inc.	KNK	Class I	1982-12-20
K822799	Streptacoccus Co-Agglutination Kit	American Scientific Products	GTP	Class I	1982-12-19
K822424	Curity Transparent Film Dressing	The Kendal Co.	FRO	Unclassified	1982-12-17
K823565	Multi-Lumen Intravenous Catheter	Mcpherson Enterprises, Inc.	FOZ	Class II	1982-12-16
K823546	Renaflo II	Renal Systems, Inc.	KOC	Class II	1982-12-16
K823509	P-S Med. Lumbo Peritoneal & Ventriculo-	Pudenz-Schulte Medical Research Corp.	JXG	Class II	1982-12-16
K823288	Amicon Diafilters 20 & 30 Hemofilters	Amicon, Inc.	KDI	Class II	1982-12-16
K823246	Austin Inhalator	Ems Industries, Inc.	BYX	Class I	1982-12-16
K823239	Sure & Natural Maxishields	Personal Products Co.	HHD	Class I	1982-12-16
K823534	Stereomed Camera	Diseases of the Skin Clinic, P.A.	FTT	Class I	1982-12-15
K823531	Behind-the-Ear Hearing Aid #8003	Danavox, Inc.	ESD	Class I	1982-12-15
K823530	Stimucord External Neural Stim. 911A	Cordis US Corp.	GZB	Class II	1982-12-15
K823529	Full-Disclosure Ambulatory ECG System	Clinical Data, Inc.	DPS	Class II	1982-12-15
K823489	Endodontic Broach-Barbed Broach	Union Broach, Div. Moyco Industries, Inc.	EKW	Class I	1982-12-15
K823479	Moduflex Neonatal Ventilator Set	BD Becton Dickinson Vacutainer Systems Preanalytic	BZO	Class I	1982-12-15
K823470	Allercoat Allergen Discs	Kallestad Laboratories, Inc.	DHB	Class II	1982-12-15
K823423	Nebulizer Chronolog & Interpreter	Advanced Technology Products, Inc.	CCQ	Class I	1982-12-15
K823412	Arm Board W/i.v Covering	Sage Products LLC	BTX	Class I	1982-12-15
K823403	Allercoat Positive Control Serum	Kallestad Laboratories, Inc.	DGC	Class II	1982-12-15
K823369	Advance Emit(r) & Tm Amikacin Control	Syva Co.	LAS	Class I	1982-12-15
K823364	Count-10 System for Stand. Urinalysis	V-Tech, Inc.	JQW	Class I	1982-12-15
K823363	Count-10 Stain	V-Tech, Inc.	LEE	Class I	1982-12-15
K823343	Oxygenator 10	Gambro, Inc.	DTZ	Class II	1982-12-15
K823311	Columbia V Agar W/5% Human Blood	Troy Biologicals, Inc.	JSH	Class I	1982-12-15
K823310	Streptococcus Selective Agar	Troy Biologicals, Inc.	JSI	Class I	1982-12-15
K823307	Campylobacter Selective Agar	Troy Biologicals, Inc.	JSI	Class I	1982-12-15
K823306	Hemophilus Quad 10 Plate	Troy Biologicals, Inc.	JSI	Class I	1982-12-15
K823299	Model 402P Sequencer for Empi Tems Dev	Epmi, Inc.	GZJ	Class II	1982-12-15
K823266	Positive I.d. System	Abbott Medical	JJQ	Class I	1982-12-15
K823202	Free & Total Estriol Kit	Siemens Healthcare Diagnostics Inc.	CGI	Class I	1982-12-15
K823177	Smec Balloon System	Smec, Inc.	DSP	Class II	1982-12-15
K823094	Cardiac Elevator	Cardio Surgical Research, Inc.	DWS	Class I	1982-12-15
K823065	Intra Cath-Dsa Intravenous Cath Place.	Parke-Davis Co.	DQO	Class II	1982-12-15
K823048	Sea Med Model 880	Seamed Corp.	DTE	Class II	1982-12-15
K823010	Micro Trak Chlamydia Trachomatis Cult	Syva Co.	LJP	Class I	1982-12-15
K823005	Bio Mag Free T4 Radioimmunoassay Kit	Bioclinical Group	CEC	Class II	1982-12-15
K822978	Mingograf 4, Mingo Card 4 & Minocard 3	Siemens Corp.	DSF	Class I	1982-12-15
K822968	Electrocardiograph Interpreter	Suzuken Co., Ltd.	DSI	Class II	1982-12-15
K822897	Dsl 1700	Diagnostic Systems Laboratories, Inc.	JHW	Class II	1982-12-15
K822843	Hts *1	Global Office Automation System, Inc.	DSK	Class II	1982-12-15