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 2026-11-02, 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 2535 of 3531

510(k) clearances, page 2535 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K900325	Orth-Evac Tm	Deknatel, Inc.	CAC	Class II	1990-07-03
K900269	Porges Dormia 3 Fr Flat Wire Basket Stone Dislodge	Porges Corp.	FFL	Class II	1990-07-03
K900246	Cardiotest Ek 53 R, Cardiognost Ek 56/ Ek 512	Ppg Industries, Inc.	DSI	Class II	1990-07-03
K897151	Acuson V328 and C5432 Transducers	Acuson Corp.	JTX	Class I	1990-07-03
K896930	Cardiac Output Computer, Model Com-3	Baxter Healthcare Corporation	DXG	Class II	1990-07-03
K884823	Transpac(r) II, Disposable Transducer	Abbott Medical	GWM	Class II	1990-07-03
K902610	General Electric Amx 3	Pro-Tronics, Inc.	IZL	Class II	1990-07-02
K902501	Flocare N	Flocare Medical	BYD	Class I	1990-07-02
K902482	Vitalmix (Set & Bag)	Pacific Device, Inc.	LHI	Class II	1990-07-02
K901956	Digital 8 W/other Numerical Suffixes (1-9, Etc.)	Eigen	LMB	Class I	1990-07-02
K901880	Medilens(tm) Corneal Shield	Chiron Ophthalmics	MOE	Class I	1990-07-02
K901593	Imex Dop-Tone II	Imex Medical Systems, Inc.	KNG	Class II	1990-07-02
K901588	Minimed(r) Model 506 External Insulin Pump	Medtronic, Inc.	LZG	Class II	1990-07-02
K901546	Needlepoint Guard	Needlepoint Guard, Inc.	FMF	Class II	1990-07-02
K901151	i.v. Administration Set Connecting Device	Dmd, Div. of Casta Pacific Co.	FPA	Class II	1990-07-02
K901023	Gastrointestinal Tubes and Accessories	MEDLINE INDUSTRIES, LP - Northfield	KNT	Class II	1990-07-02
K900884	P.r.g. Percutaneous Replacement Gastrostomy	Applied Medical Technologies	KGC	Class II	1990-07-02
K900480	M1350a Fetal Monitor (Intrapartum)	Hewlett-Packard Co.	HGM	Class II	1990-07-02
K900048	Hyperthermia Sensor Accessories	Valley Medical Research, Inc.	FLL	Class II	1990-07-02
K895942	Gesco Dual Lumen per-Q-Cath-Dl	Gesco Intl., Inc.	FOZ	Class II	1990-07-02
K902656	Gynescope Laparoscopic Trocars and Sleeves	Gynescope Corp.	HET	Class II	1990-06-29
K902603	Liberty, Freedom & Independence Immers Hydro Bath	Unique Bathing Supplies, Inc.	ILJ	Class II	1990-06-29
K902535	Sony Wbs-700H Videocassette Recorder System	Sony Medical Electronics Co.	JAA	Class II	1990-06-29
K902211	Surgilase Yag 100 Surgical Laser System	Surgilase, Inc.	GEX	Class II	1990-06-29
K902132	Cuff, Blood Pressure	Buffalo Medical Specialties Mfg., Inc.	DXQ	Class II	1990-06-29
K902063	Niic Model 15 Carbon-Dioxide Surgical Laser System	Niic U.S.A., Inc.	GEX	Class II	1990-06-29
K902058	Add'l Use of the Ktp/yag Surgical Laser	Laserscope	GEX	Class II	1990-06-29
K901897	Zeppelin Forceps	Kirwan Surgical Products, LLC	HCZ	Class II	1990-06-29
K901782	Convertray Custom Impression Tray Material System	Productivity Training Corp.	EBH	Class I	1990-06-29
K901610	Sullivan Variable Stiffness Cable	Wilson-Cook Medical Inc.	FDF	Class II	1990-06-29
K901574	Ackrad Mpr Drainage Catheter Set	Ackrad Laboratories	KNT	Class II	1990-06-29
K901499	Neuromed Octrode Model Mnr-88 W/98 Adapter Neuro.	Neuromed, Inc.	GZB	Class II	1990-06-29
K901300	Biopsy Forceps	Portlyn Corp.	DWZ	Class II	1990-06-29
K896107	Rubber Contraceptive	Banrub Sdn Bhd	HIS	Class II	1990-06-29
K902636	Lipogen Rheumelisa Dsdna Assay	Lipogen, Inc.	LRY	Class I	1990-06-28
K902593	Raichem(tm) Spia(tm) Crp Reagent	Reagents Applications, Inc.	DCN	Class II	1990-06-28
K902541	Mono-Lex System: Infectious Mononucleosis Latex	Trinity Laboratories, Inc.	KTN	Class II	1990-06-28
K902398	Ciba Corning Magic Lite Lh Immunoassay	Ciba Corning Diagnostics Corp.	CEP	Class I	1990-06-28
K902388	Dental-Quecksilber (Dental Mercury)	Degussa AG	ELY	Class II	1990-06-28
K902387	Degussa Stopfgold (Degussa Direct-Filling Gold)	Degussa AG	EJT	Class II	1990-06-28
K902376	Dw231 Dental Alloy	Ivoclar North America, Inc.	EJS	Class II	1990-06-28
K902373	200 Silhouette Line (Sl) Ceramic Solder	Leach and Dillon Co., Inc.	EJT	Class II	1990-06-28
K902372	Silver-Free Ceramic Solder (Sfcs)	Leach and Dillon Co., Inc.	EJT	Class II	1990-06-28
K902328	Synermed Total Bilirubin Reagent Kit	Synermed, Inc.	CIG	Class II	1990-06-28
K902321	Hi Chem Enzyme Linearity Standards (Prod. 88235)	Hichem Diagnostics	JJT	Class I	1990-06-28
K902172	Coulter Creatinine Reagent	Coulter Corp.	CGX	Class II	1990-06-28
K902136	Kodak Surecell(tm) Hcg-Urine Test Kit	Eastman Kodak Company	JHI	Class II	1990-06-28
K901980	Mobile Mrp-20 Magnetic Resonance Diagnostic Device	Summit World Trade Corp.	LNH	Class II	1990-06-28
K901933	Coat-a-Count Pap Irma, Catlog# 1Kpa1, 1Kpa2	Siemens Healthcare Diagnostics Inc.	JFH	Class II	1990-06-28
K901917	Dual Cement	Ivoclar North America, Inc.	EBF	Class II	1990-06-28