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 3131 of 3528

510(k) clearances, page 3131 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K832375	Liquid Chromatograph 1090 Series	Hewlett-Packard Co.	LDM	Class I	1983-10-14
K832362	Donaldson-Type Vent Tube	Concept, Inc.	ETD	Class II	1983-10-14
K832361	Concept T-Tube	Concept, Inc.	ETD	Class II	1983-10-14
K832360	Abbott Ige Eia	Abbott Medical	DGC	Class II	1983-10-14
K832230	Dialyzer Preparation Sys Dps-4	Seratronics, Inc.	LIF	Class II	1983-10-14
K832212	Patient Selector Function Block	Honeywell, Inc.	DPS	Class II	1983-10-14
K832196	Sheridan/levi-a-Sump	Sheridan Catheter Corp.	KNT	Class II	1983-10-14
K832189	Hemochron Thrombochronometer	Accriva Diagnostics, Inc.	JBP	Class II	1983-10-14
K832141	Microstar Vc1 Volumetric Cycler	Medionics International, Inc.	FKX	Class II	1983-10-14
K832136	Dual Flow Needle	Travenol Laboratories, S.A.	FIE	Class II	1983-10-14
K831987	Epsilon Ige Test Kit	Beckman Instruments, Inc.	DGO	Class II	1983-10-14
K831766	Microstar Vci	Medionics International, Inc.	FKX	Class II	1983-10-14
K831574	Blood Gas Quality Control Soft-86000F	Computermate, Inc.	JQP	Class I	1983-10-14
K831429	As 191 ECG Telemetry Module	Narco Scientific	DPS	Class II	1983-10-14
K831428	As 1740 Interface Module	Narco Scientific	DRT	Class II	1983-10-14
K831424	Therapeutic Exchange Blood Tubing-Tp-101	Extracorporeal Medical Specialities, Inc.	FJK	Class II	1983-10-14
K831407	Cardiac Output Computer	Ziehm International, Inc.	DXG	Class II	1983-10-14
K831386	Groshong Catheter, Long Term Type	Catheter Technology Corp.	LJS	Class II	1983-10-14
K831287	E-Z Fit	Triad Medical Division	KKX	Class II	1983-10-14
K830778	Monitoring Kit Amk-1	Alternative Design Systems, Inc.	FLS	Class II	1983-10-14
K831633	Quantum Bipolar Cardiac Pulse Generator	Intermedics, Inc.	DXY	Class III	1983-10-12
K832371	Egs Model 300	Electro-Med Health Industries, Inc.			1983-10-06
K831851	Straight Stem Femoral Head Prosthesis	Proteck, Inc.	KWL	Class II	1983-10-06
K831962	Chlamydiazyme, Enzyme Immunoassay Detec	Abbott Medical	LJC	Class I	1983-10-05
K833039	Handy Iim	Shofu Dental Corp.	EJP	Class I	1983-10-04
K833038	Summa Disk	Shofu Dental Corp.	DZP	Class I	1983-10-04
K832997	Epa Automated Infusion Pole	Miami Eye Technology, Inc.	HQC	Class II	1983-10-04
K832958	Freeman Acetabular Cup	Depuy, Inc.	JDI	Class II	1983-10-04
K832952	Millipore Ivex Int Filter Unit	EMD Millipore Corporation	FPB	Class II	1983-10-04
K832949	Sanodent Double-Ended Interdental Clean	Coopercare, Inc.	JET	Class I	1983-10-04
K832939	I-Glide IOL Implantation Aid	I for M, Inc.	KYB	Class I	1983-10-04
K832893	Model 329T Programmable, Bipolar Cardi	Cook Pacemaker Corp.	DXY	Class III	1983-10-04
K832887	Electronic Unit	Surgi-Quip Inc.U	EPT	Class I	1983-10-04
K832856	Gingi Curettage Diamond Points	Shofu Dental Corp.	DZP	Class I	1983-10-04
K832849	Fetal Monitor #Fm-2	Advantage Medical Systems, Inc.	HGM	Class II	1983-10-04
K832848	Chemonucleolysis Table #6100	Kirschner Medical Corp.			1983-10-04
K832829	Neo-Float Neonatal Flotation Sys & Rhyt	Clinical Data Instruments, Inc.	IOQ	Class II	1983-10-04
K832787	Elecath Heparin Coated Thermal Dilution	Electro-Catheter Corp.	KYG	Class I	1983-10-04
K832720	Emit AED Carbamazepine Assay	Syva Co.	KLT	Class II	1983-10-04
K832719	Emit AED Valproic Acid Assay	Syva Co.	LEG	Class II	1983-10-04
K832716	Encore Chemistry Analyzer	Baker Instructions Corp.	JJG	Class I	1983-10-04
K832712	Folate Radioassay Kit Ca-1562-125	Clinical Assays, Inc.	CGN	Class II	1983-10-04
K832711	Vitamin B12 Folate Ca-1515-125	Clinical Assays, Inc.	CDD	Class II	1983-10-04
K832710	Vitamin B12 Radioassay Kit Ca-1534	Clinical Assays, Inc.	CDD	Class II	1983-10-04
K832706	Sensitive Eyes	Bausch & Lomb Incorporated	HPX	Unclassified	1983-10-04
K832695	Lyphochek Serum Ref. Standard-Bovine	Bio-Rad	JIX	Class II	1983-10-04
K832684	Seralyzer Triglycerides Reagent Strips	Miles Laboratories, Inc.	CDT	Class I	1983-10-04
K832662	Dental Syringe System-Various Styles	Centrix, Inc.	KXR	Class I	1983-10-04
K832658	Director	Pharmacia, Inc.	FMF	Class II	1983-10-04
K832651	Ati Forehead Thermometer	American Thermal Instruments, LLC	KPD	Class II	1983-10-04