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 2026-10-08, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,902 of the 176,299 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	2,502

176,299 records, page 3403 of 3526

510(k) clearances, page 3403 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K790982	Inspiron Nebulo Tm 28 Nebulizer Kit	C.R. Bard Inc	CAF	Class II	1979-06-27
K790969	Argyle Urine Meter	Sherwood Medical Co.	KNX	Class II	1979-06-27
K790967	Catheter Metal Hub/radiopaque	Jelco Laboratories	FOZ	Class II	1979-06-27
K790953	Bordispo Brand Hypodermic Needle	Borda Products, Inc.	FMI	Class II	1979-06-27
K790942	Radview Imager System	General Electric Co.	JAK	Class II	1979-06-27
K790915	Juhn Tym-Tap	Xomed, Inc.	FMH	Class I	1979-06-27
K790911	Ria of Progesterone	Calbiochem-Behring Corp.	JLS	Class I	1979-06-27
K790908	Ria, Test Set Centria T3	Ventrex Laboratories, Inc.	CDP	Class II	1979-06-27
K790907	Autopak Test Delivery System	Micromedic Systems	CDX	Class II	1979-06-27
K790906	Autopak Cortisol Test Delivery System	Micromedic Systems	CGR	Class II	1979-06-27
K790902	Integrated Patient Stations	Extracorporeal Medical Specialities, Inc.			1979-06-27
K790901	i.v. Tubing Organizer	Acumed Instruments Corp.	FPA	Class II	1979-06-27
K790891	Tempo2-II Disposable Thermometers	Airlife, Inc.	FLK	Class II	1979-06-27
K790890	Tempo2-I Disposable Thermometers	Airlife, Inc.	FQZ	Class I	1979-06-27
K790888	Trach T with One-Way Valves	Airlife, Inc.	BZA	Class I	1979-06-27
K790841	Tg 2, Tri-Gard Pressure Monitor	Sorensen Research	KOC	Class II	1979-06-27
K790824	Repgreen Ultrafiltration Monitor	Cyberex Corp.	FIL	Class II	1979-06-27
K790814	Delta Pump	Spiess Design, Inc.	FRN	Class II	1979-06-27
K790670	Pulse Generator Model 629	Elema-Schonander, Inc.	DXY	Class III	1979-06-27
K790650	Weiss Emergency Airway System	Intl. Medical Devices, Ltd.	BWC	Class II	1979-06-27
K791170	Mis Aural Acoustic Screener	Maico Hearing Instruments, Inc.	EWO	Class II	1979-06-25
K791107	Stopcock, Three Way	Norton Performance Plastics Corp.	DTL	Class II	1979-06-22
K791098	Single-Use Mini-Bulldog	Med General	DXC	Class II	1979-06-22
K791030	Hemoglobin Af/sc Electrophoresis Control	Beckman Instruments, Inc.	JPK	Class II	1979-06-22
K791026	4F Sterile Balloon-Less, Catheter 913-28	Waters Assoc., Inc.	KRB	Class II	1979-06-22
K791001	Penlight/swab Holder	Concept, Inc.	KYT	Class I	1979-06-22
K790999	Apollo Heart Rate Indicator	Apollo Products, Inc.	JOM	Class II	1979-06-22
K790992	Pseudo-Palette Tm	Micro-Palettes, Inc.	JSW	Class I	1979-06-22
K790991	Yeast-Palette Tm	Micro-Palettes, Inc.	JXB	Class I	1979-06-22
K790987	Zimmer R Total Shoulder II	Zimmer GmbH	KWT	Class II	1979-06-22
K790943	Trisedta-Borate Electrophoresis Film Aga	Corning Medical & Scientific	GHS	Class II	1979-06-22
K790930	Trache Fitting M-307	Mem Medical, Inc.	BTO	Class II	1979-06-22
K790923	Mi-Mark Endocervical Sampling Set	Simpson/Basye, Inc.	KNA	Class II	1979-06-22
K790918	Esklab Reagent Tablets	Smithkline Diagnostics, Inc.	JHS	Class II	1979-06-22
K790917	Spin Chem Ck-Nac Reagent	Smithkline Diagnostics, Inc.	JHS	Class II	1979-06-22
K790916	Ck-Nuc Reagent	Smithkline Diagnostics, Inc.	JHS	Class II	1979-06-22
K790835	Dynaject	Atomic Products Corp.	DXT	Class II	1979-06-22
K790793	Amc R Metacarpal Component	Howmedica Corp.	KWN	Class II	1979-06-22
K782154	Colostomy Device, Maclet Magnetic	Maclet Medical Devices, Inc.			1979-06-21
K791093	Models 2411/2418 Ventricular-Inhibited	Medtronic, Inc.	DXY	Class III	1979-06-20
K791073	Wrench	Truth, Inc.	HXC	Class I	1979-06-20
K791070	Accu-Sorb Sterile Stockinettes	MEDLINE INDUSTRIES, LP - Northfield	KKX	Class II	1979-06-20
K791062	Boundary Specialty Gown	Procter & Gamble Mfg. Co.	FYA	Class II	1979-06-20
K791057	Cast Brace Components	3M Company	IQI	Class I	1979-06-20
K790974	Mic-2000 Inoculator Template	Dynatech Laboratories, Inc.	JTC	Class I	1979-06-20
K790971	Mic-2000 Quad Inoculum Tray	Dynatech Laboratories, Inc.	JTC	Class I	1979-06-20
K790955	Cover Gard	Fem-Gard, Inc.	FRK	Class I	1979-06-20
K790954	Heel Gard	Fem-Gard, Inc.	FRK	Class I	1979-06-20
K790738	Habitsabater	Jackson Ent.	HCB	Class II	1979-06-20
K790696	Rdi-1 Hollow Fiber Dialyzer	Renal Devices, Inc.	FJI	Class II	1979-06-20