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 3393 of 3526

510(k) clearances, page 3393 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K791579	Anaerobic Brucella Blood Agar	Anaerobe Systems	JSI	Class I	1979-09-17
K791577	Elvi 840 Aggregometer	Volu Sol Medical Industries	JOZ	Class II	1979-09-17
K791563	Anaerobic Brucella Laked Blood Agar	Anaerobe Systems	JSI	Class I	1979-09-17
K791562	Anaerobic Brucella Blood Agar	Anaerobe Systems	JSG	Class I	1979-09-17
K791557	Martin-Lewis Agar (Plate)	American Laboratory Supply, Inc.	JTY	Class II	1979-09-17
K791556	Macconkey Agar (Plate)	American Laboratory Supply, Inc.	JSH	Class I	1979-09-17
K791555	Levine Eosin Methyler	American Laboratory Supply, Inc.	JSI	Class I	1979-09-17
K791554	Transgrow	American Laboratory Supply, Inc.	JTY	Class II	1979-09-17
K791553	Chocolate Agar	American Laboratory Supply, Inc.	JSG	Class I	1979-09-17
K791546	Columbia Cna Blood Agar	Isle Media and Sterile Products, Inc.	JSR	Class I	1979-09-17
K791545	Transport Medium Amies	Isle Media and Sterile Products, Inc.	JSM	Class I	1979-09-17
K791544	Tryptic Soy Agar with Sheep Blood	Isle Media and Sterile Products, Inc.	JSG	Class I	1979-09-17
K791543	Transport Medium Amies without Charcoal	Isle Media and Sterile Products, Inc.	JSM	Class I	1979-09-17
K791542	Thioglycollate Medium without Indicator	Isle Media and Sterile Products, Inc.	JSG	Class I	1979-09-17
K791505	Rohnar 7000 Digital Diagn Ultrasound	Roche Scientific Corp.	IYO	Class II	1979-09-17
K791465	Mosquito Arterial Blood Sampler	Emde Corp.	CBT	Class I	1979-09-17
K791463	Para-Vent	Cameron Medical Corp.	BTC	Class I	1979-09-17
K791447	Martin Lewis Agar Csi 3169	Clinical Sciences, Inc.	JTY	Class II	1979-09-17
K791446	Martin Lewis Jembec Csi 8872	Clinical Sciences, Inc.	JTY	Class II	1979-09-17
K791433	Kotex Lightdays Deodorant Patiliners	Kimberly-Clark Corporation	HHL	Class II	1979-09-17
K791425	Modified Thayer-Martin Agar (Plate)	American Laboratory Supply, Inc.	JTY	Class II	1979-09-17
K791405	125I Leutinizing Hormone Ria Kit	Siemens Healthcare Diagnostics Inc.	CEP	Class I	1979-09-17
K791371	Model F-1010 Digital Thermometer	Filac Corp.	FLL	Class II	1979-09-17
K791368	Ventre/sep T4 Test Set	Ventrex Laboratories, Inc.	CDX	Class II	1979-09-17
K791356	Earette Hearing Aid	Oticon, Inc.	ESD	Class I	1979-09-17
K791354	Code Qas 103 Anti-DNA Controls	Amersham Corp.	KTL	Class II	1979-09-17
K791348	Round Washbasin & Rectangle Washbasin	General Clinical Plastics Corp.			1979-09-17
K791344	Model 1350 Graphics Translator	Hewlett-Packard Co.	IYO	Class II	1979-09-17
K791343	Model 1338A Crt Display	Hewlett-Packard Co.	IYO	Class II	1979-09-17
K791317	Irex Real Time Phased Array System	Irex Corp.	CDP	Class II	1979-09-17
K791303	Dorn Blood Culture Collection Tube	Wadley Institutes of Molecular Medici	JKA	Class II	1979-09-17
K791279	Kolposkop Kp20005	Elmed, Inc.	HEX	Class II	1979-09-17
K791201	Scintistress System	Cambridge Instruments, Inc.	DPS	Class II	1979-09-17
K791178	Myvacet 5-07, 7-00 and 9-40	Radiation Products Design, Inc.	IXI	Class II	1979-09-17
K791149	Stimulator Model Sss-1101	Nihon Kohden America Inc	GWE	Class II	1979-09-17
K791055	Adac Tomography Option	Philips North America LLC	KPS	Class II	1979-09-17
K791024	Ultrasonic Dental Prophylaxis Unit	Litton Dental Products	ELC	Class II	1979-09-17
K791013	Spectra R Pad	Parker Laboratories, Inc.	GYB	Class II	1979-09-17
K791734	Surgical Instruments Heifetz Digitate	Edward Weck, Inc.	FZT	Class I	1979-09-12
K791710	Cardiovascular Instruments-Various	Edward Weck, Inc.	DWS	Class I	1979-09-12
K791660	Prepacell-Bone Marrow Sampler	Applied Medical Devices, Inc.	FMF	Class II	1979-09-12
K791643	Bone Marrow Needle	Johannah Medical Services, Inc.	GDM	Class I	1979-09-12
K791639	Model E2515 Electrosurgical Accessory	Medtronic, Inc.	GEI	Class II	1979-09-12
K791638	Model E2510 Surgiswitch	Medtronic, Inc.	GEI	Class II	1979-09-12
K791637	TENS-O-Test	Curomatic, Inc.	DXN	Class II	1979-09-12
K791574	Modified Tempa-Dot Thermometer	Info-Chem	FQZ	Class I	1979-09-12
K791558	Temp-Stik Model #300	Temp-Stik Corp.	FLL	Class II	1979-09-12
K791531	Flexiflo Enteral Pump Set	Abbott Medical	BSS	Class II	1979-09-12
K791528	Flexifo Enteral Nutrition Pump	Abbott Medical	FRN	Class II	1979-09-12
K791379	Model 228-02 Thinlith II Pacemaker, Bipo	Intermedics, Inc.	DXY	Class III	1979-09-12