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 3435 of 3526

510(k) clearances, page 3435 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K781127	Connecting Tube, Conductive, Surg.	Seamless Hospital Products Co.	GAZ	Class II	1978-09-20
K781535	Ac Adapter:models 9525,9526,9527	Edwards Laboratories	DXG	Class II	1978-09-15
K781290	Signal Averager Model 4202	Princeton Applied Research Corp.	GWK	Class II	1978-09-15
K781167	Stemplex	Rich-Mar Corp.	IPF	Class II	1978-09-15
K781043	Cea-Immersible Separator	EMD Millipore Corporation	JRL	Class I	1978-09-15
K781540	Opti 110/12/50 Hsg	Siemens Corp.	ITY	Class I	1978-09-14
K781536	Vac-U-Pac Kidney Cassette	E-Z-EM, Inc	JXA	Class I	1978-09-14
K781532	Uroskop a and B	Siemens Corp.	IXR	Class II	1978-09-14
K781531	Optiplanimat	Siemens Corp.	IZF	Class II	1978-09-14
K781519	Emi Simulator Remote Control Console	Emi Medical, Inc.	KPQ	Class II	1978-09-14
K781513	Hearing Aid, Unitron Model 960Pl	Unitron Industries, Inc.	ESD	Class I	1978-09-14
K781500	Model 845T Imaging/ergometer Table	Quinton, Inc.	JYZ	Class I	1978-09-14
K781496	Ximatron IV	Siemens Elema AB	KPQ	Class II	1978-09-14
K781495	Rianen Assay System, 125I Kit	New England Nuclear	DNL	Class II	1978-09-14
K781462	Auto-Field II Ophthalmic Field Scanner	Cavitron Corp.	HPT	Class I	1978-09-14
K781435	Ortho Low Ionic Solution	Ortho Diagnostics, Inc.	KSG	Class II	1978-09-14
K781397	Em-V	Biological Corp. of America	KSG	Class II	1978-09-14
K781396	Creatinine Reagent Set	Nobel Scientific Industries, Inc.	CGX	Class II	1978-09-14
K781386	Ebs 775 Tonometer	Equilibrated Bio Systems, Inc.	LCH	Class I	1978-09-14
K781379	Model 5000, Liquid Chromatography	Varian Assoc., Inc.	KIE	Class I	1978-09-14
K781376	Standardize Tgcl & Tgch	American Monitor Corp.	JTX	Class I	1978-09-14
K781361	Hemoglobinometer Model 720 B	Innovative Medical Systems, Inc.	GKR	Class II	1978-09-14
K781289	Preamplifier Model 113	Princeton Applied Research Corp.	GWL	Class II	1978-09-14
K781247	Quanticel-Hrp	Bhp Diagnostix, Inc.	JPK	Class II	1978-09-14
K781214	Cameras, Multi-Image	Dunn Instruments, Inc.			1978-09-14
K781174	Clinac 12/10	Varian Assoc., Inc.	IYE	Class II	1978-09-14
K781173	Computer Interface Il 814	Instrumentation Laboratory Co.	JQP	Class I	1978-09-14
K781146	Hemac Laser Hematology System	Ortho Instruments	GKL	Class II	1978-09-14
K781142	Disscap	Hospal Medical Corp.	FJI	Class II	1978-09-14
K781109	Forceps, Electrosurgical	Kli	HIN	Class II	1978-09-14
K781037	Pressure Infusion Device	Hinck Medical, Inc.	KZD	Class I	1978-09-14
K780078	Oxygenator, Bubble Type	Bentley Laboratories, Inc.	DTZ	Class II	1978-09-14
K781502	Hearing Aid, Unitron Model 761P	Unitron Industries, Inc.	ESD	Class I	1978-09-11
K781492	Series 7000 Gas Machine	Narco Mckesson Co.	BSZ	Class II	1978-09-11
K781473	Bucky Wall Stand	Philips North America LLC	KPR	Class II	1978-09-11
K781428	Flextubes:9, 20, 26	Bourns Medical Systems, Inc.	BYX	Class I	1978-09-11
K781425	Cap-Mobile	Philips North America LLC	IZL	Class II	1978-09-11
K781416	Tubing, Flexible, Medical Gas	Vitalab Products Corp.	BYX	Class I	1978-09-11
K781288	Dental X-Ray Unit Heliodent 70	Siemens Corp.	EHD	Class II	1978-09-11
K781287	Dental X-Ray Unit W/cephalometric Attach	Siemens Corp.	EAG	Class II	1978-09-11
K781286	Dental X-Ray Unit	Siemens Corp.	EHD	Class II	1978-09-11
K781231	Oxygen Supply Tube, Disp., Plastic	Rtec	BYX	Class I	1978-09-11
K781475	Electrode Impedance Tester-Model 500	Life-Tech Instruments, Inc.	GYA	Class I	1978-09-07
K781474	Preamplifier Models 8101Pi & 8102Pi	Life-Tech Instruments, Inc.	EWO	Class II	1978-09-07
K781470	Modess* Beltless Feminine Napkin	Personal Products Co.	HHD	Class I	1978-09-07
K781468	Continuous Feed Valve 2D9024	Travenol Laboratories, S.A.	BTT	Class II	1978-09-07
K781467	U-Float Valve 2D9023	Travenol Laboratories, S.A.	CAF	Class II	1978-09-07
K781458	Radioear Re Series Hearing Aids	Radioear Corp.	ESD	Class I	1978-09-07
K781440	Lensometer Model 11	Rodenstock Instrument Corp.	HLM	Class I	1978-09-07
K781431	Electric Ct/t Operator Display Console	General Electric Co.	JAK	Class II	1978-09-07