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 2506 of 3531

510(k) clearances, page 2506 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K902143	Fogarty Vessel Calibrator	Baxter Healthcare Corporation	DWP	Class II	1990-10-16
K900607	Mk5 Detector & Alarm, Arrhythmia W/software 2.11	Cardiodata Corp.	DSI	Class II	1990-10-16
K897106	Medi-Tech Dilatation Catheters Ultra Thin II	Boston Scientific Corporation	LIT	Class II	1990-10-16
K904489	Eureka Extension Cylinders	Eureka X-Ray Tube Corp.	KPW	Class II	1990-10-15
K904306	Dupont Drug Calibrator-a	E.I. Dupont de Nemours & Co., Inc.	JJX	Class I	1990-10-15
K904305	Dupont Dimension(r) Gentamicin(gent) Method	E.I. Dupont de Nemours & Co., Inc.	LCD	Class II	1990-10-15
K904295	Proguard(tm) Blood Collection Needle	Safety-Ject, Inc.	FMI	Class II	1990-10-15
K904252	Heatwave	Medadvances, Inc.	LGZ	Class II	1990-10-15
K904224	Nova Lite Tm Thyroid	Inova Diagnostics, Inc.	JZO	Class II	1990-10-15
K904220	Synchron Cx4-Ce	Beckman	JJE	Class I	1990-10-15
K904168	Accu-Chek (R) Easy (Tm) Blood Glucose System	Boehringer Mannheim Corp.	CGA	Class II	1990-10-15
K904105	V-Trend Target RF Test	Texas Immunology, Inc.	DHR	Class II	1990-10-15
K904100	Dsl Sex Hormone Binding Globulin (Shbg) (Dsl 6300)	Diagnostic Systems Laboratories, Inc.	CDZ	Class I	1990-10-15
K904016	Maxi Test	Bhc Biotech, Ltd.	JHI	Class II	1990-10-15
K903742	Add Mix Allergen Panel Mod Alastat(r) Allergen Ige	Siemens Healthcare Diagnostics Inc.	DHB	Class II	1990-10-15
K903738	Quidel Allergen Screen Positive Control	Ortho-Clinical Diagnostics, Inc.	DGC	Class II	1990-10-15
K903668	Wilson-Cook Aspiration Handle	Wilson-Cook Medical Inc.	FBK	Class II	1990-10-15
K903626	Biomek Automated Laboratory Workstation W/genelisa	Beckman Instruments, Inc.	JJG	Class I	1990-10-15
K903378	Model C286 Isolette Infant Incubator	Air-Shields Vickers, Inc.	FMZ	Class II	1990-10-15
K903191	Quick Check 3 Film	Quantai Biotronics, Inc.	CGA	Class II	1990-10-15
K902906	Gas-Vak(r) Combination Sterilizer & Ventilator	Gas-Vak	FLI	Class II	1990-10-15
K902161	Demistifier Isolation Chamber	Peace Medical, Inc.	CBN	Class II	1990-10-15
K904525	Patient Examination Gloves	Jian Win Latex Product Factory	LYY	Class I	1990-10-12
K904511	Hand-Carried Stretchers/break Away Flat	Minto Research & Development, Inc.	FPP	Class I	1990-10-12
K904494	Hand-Carried Stretchers	Minto Research & Development, Inc.	FPP	Class I	1990-10-12
K904458	Lumatag(tm) Prolactin Diagnostic Kit/modification	London Diagnostics, Inc.	CFT	Class I	1990-10-12
K904381	Diazo Colorimentry Direct Bilirubin	Amresco, Inc.	CIG	Class II	1990-10-12
K904335	Secondary Calibrators	Bionostics, Inc.	JGS	Class II	1990-10-12
K904308	Dupont Alcohol Calibrator	E.I. Dupont de Nemours & Co., Inc.	DLJ	Class II	1990-10-12
K904302	Dupont Dimension(r) Ethyl Alcohol(alc) Method	E.I. Dupont de Nemours & Co., Inc.	DIC	Class II	1990-10-12
K904293	Hi Chem Bilirubin Linearity Set (Product #88237)	Hichem Diagnostics	JJY	Class I	1990-10-12
K904271	Oxlife	Medical Repair Service, Inc.	CAW	Class II	1990-10-12
K904261	Litter, Nonridgid, Poleless, Nylon Stretcher	Dow Cover Co., Inc.	FPP	Class I	1990-10-12
K904049	Roche Cobas Ready Renal Profile Reagent Strip	Roche Diagnostic Systems, Inc.	JGZ	Class II	1990-10-12
K903904	Series 2000 Adjustable Bed	Equi-Tron Mfg., Inc.	FNL	Class II	1990-10-12
K903880	Franz(tm) Steerable Combination Catheter	Ep Technologies, Inc.	DRF	Class II	1990-10-12
K903773	Synermed Ldh Reagent Kit	Synermed, Inc.	CFJ	Class II	1990-10-12
K903691	A-Port Implantable Vascular Access System Line Ex.	Therex Corp.	LJT	Class II	1990-10-12
K903620	Modified Endoscopic Carpal Tunnel Release System	Smith & Nephew Dyonics, Inc.	HRX	Class II	1990-10-12
K903608	V-Link	GE Healthcare	CAW	Class II	1990-10-12
K903543	Synermed Albumin Reagent Kit	Synermed, Inc.	CIX	Class II	1990-10-12
K903465	Ir-192 Implant	Rads S.L., Inc.	KXK	Class II	1990-10-12
K903433	Tdx Free T3 Calculation	Abbott Medical	CDP	Class II	1990-10-12
K903396	Il T Uptake Assay System	Instrumentation Laboratory Co.	KHQ	Class II	1990-10-12
K903391	Allegro Lite Thyroid Stimulating Hormone Chem. Imm	Nichols Institute	JLW	Class II	1990-10-12
K903304	Roche Cobas Ready Ggt Reagent	Roche Diagnostic Systems, Inc.	JPZ	Class I	1990-10-12
K903286	Continuum Knee System (Cks)-Modification	Techmedica, Inc.	HSX	Class II	1990-10-12
K903235	Statlab a-350 Saliva Alcohol Test	Enzymatics C/O Burditt,Bowles,Radzius & Ruberry	DIC	Class II	1990-10-12
K903187	Laparoscopic Catherter	Cook Ob/Gyn	HET	Class II	1990-10-12
K903146	Hysteroscopy Sheath Set	Cook, Inc.	HIH	Class II	1990-10-12