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 3198 of 3528

510(k) clearances, page 3198 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K822706	Pre-Sert	Allergan	HPX	Unclassified	1982-10-22
K822613	Rast Allercoat Allergen Discs	Kallestad Laboratories, Inc.	DGC	Class II	1982-10-22
K822577	Operand Suture Removal Tray	Medcare Products			1982-10-22
K822573	Sunglass Lenses	Zeiss	HQG	Class I	1982-10-22
K822508	Minisampler Tm	Bms, Inc.	JKA	Class II	1982-10-22
K822436	DNA Medical Duracath	Moorehead Hospital Products, Inc.	BSO	Class II	1982-10-22
K822402	Roto Rest Kinetic Treatment Table Pedia	KCI USA, Inc.	IKZ	Class II	1982-10-22
K822259	Laryngeal Spatulas	Kelleher Corp.	EQH	Class I	1982-10-22
K822145	Complete	Richard-Allan Medical Ind., Inc.	FZQ	Class I	1982-10-22
K828325	Yoshida/kaycor X-70 X-Ray Unit	The Yoshida Dental Mfg. Co., Ltd.			1982-10-21
K822786	Mdm Arterial Blood Gas Kit	Martell Medical Products, Inc.	CBT	Class I	1982-10-21
K822759	Abbott Laboratories Prolactin Eia	Abbott Medical	CFT	Class I	1982-10-21
K822712	Inpersol-Capd Adminis. Set Type Dp	Abbott Medical	FKX	Class II	1982-10-21
K822658	Extension Set Type Dp	Abbott Medical	FKX	Class II	1982-10-21
K822417	New Enzymatic Single Reagent Free Chol.	Sclavo, Inc.	CHH	Class I	1982-10-21
K822248	Deseret Arterial Blood Sampling Kit	Warner-Lambert Co.	CBT	Class I	1982-10-21
K822150	Amnistat-Flm	Hana Biologics, Inc.	JHG	Class II	1982-10-21
K822039	Beckman Astra	Beckman Instruments, Inc.	JGS	Class II	1982-10-21
K822004	Face Shields	Kelleher Corp.	KNT	Class II	1982-10-20
K822905	Latest RF Kit for Rheumatoid Factor	Fisher Scientific Company L.L.C.	DHR	Class II	1982-10-18
K822894	Diabrite	Antraco, Inc.	EJR	Class I	1982-10-18
K822880	Arterio Venous Shunt Cannula & Adaptors	Renal Systems, Inc.	FIQ	Class II	1982-10-18
K822878	Model 78553A Pressure Plug-in Module	Hewlett-Packard Co.	DSK	Class II	1982-10-18
K822877	Model 78554A Data Mgmt. Plug-in Module	Hewlett-Packard Co.	DXG	Class II	1982-10-18
K822876	Model 78534A Patient Monitor	Hewlett-Packard Co.	DRT	Class II	1982-10-18
K822874	Thermostatic Water Mixing Valve Twv10	Gambro, Inc.	DWC	Class II	1982-10-18
K822865	Surgi-Scrub V	Acme United Corp.	GEC	Class I	1982-10-18
K822862	Brachial Coronary Guiding Catheter	Advanced Cardiovascular Systems, Inc.	DQO	Class II	1982-10-18
K822858	Coat-a-Count Tobramycin Ria Kit	Siemens Healthcare Diagnostics Inc.	KLB	Class II	1982-10-18
K822853	Model 200 Squid	Synemed, Inc.	HPT	Class I	1982-10-18
K822832	Ticarcillin 75Mcg. Sensi-Disc	BD Becton Dickinson Vacutainer Systems Preanalytic	JTN	Class II	1982-10-18
K822823	Hematology Computer-Interface, Viscount	Eko Scann AB	LKM	Class II	1982-10-18
K822822	Gambro Pressure Monitor Prm 10	Gambro, Inc.	DXS	Class II	1982-10-18
K822821	Gambro Blood Level Detector Lcs 10	Gambro, Inc.	DTW	Class II	1982-10-18
K822820	Gas-Flow Meter Gfl 10	Gambro, Inc.	DTX	Class II	1982-10-18
K822796	Negative Pressure Arterial Blood Line	Erika, Inc.	KOC	Class II	1982-10-18
K822758	Sysmex Pda-410 (Particle Distrib. Analy	Toa Medical Electronics USA, Inc.	GKL	Class II	1982-10-18
K822747	Pilling Lacrimal Intubation System(ster.	Narco Scientific			1982-10-18
K822739	Ahbd	Gilford Diagnostics	JMK	Class I	1982-10-18
K822731	Hemotect	Bio-Chem Laboratories	KHE	Class II	1982-10-18
K822707	Clean-N-Soak	Allergan	HPX	Unclassified	1982-10-18
K822656	C-200 Infant Incubator	Narco Scientific	FMZ	Class II	1982-10-18
K822616	Ls6 Arrythmia Discriminator	Life Science Instrumentation, Inc.	DSI	Class II	1982-10-18
K822586	Teflon Coated Guide Wires & Catheter	Universal Medical Instrument Corp.	DQX	Class II	1982-10-18
K822557	Specimen Adaptor	Bemis Health Care	BYZ	Class II	1982-10-18
K822556	Critical Measurement Unit	Bemis Health Care	BYZ	Class II	1982-10-18
K822454	Syringe Pump 209-100	Medix Corp.	FRN	Class II	1982-10-18
K822447	Surgicare Model 1000	Surgicare Scientific Laboratory, Inc.			1982-10-18
K822326	Blended Detergent-78N 1912-1	Interscience, Inc.	PPM	Class I	1982-10-18
K822325	Blood Cell Diluent 78N 1913	Interscience, Inc.	GIF	Class I	1982-10-18