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 2026-10-22, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 2941 of 3529

510(k) clearances, page 2941 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K852645	Fluid Management System	Haemonetics Corporation	FRN	Class II	1985-12-09
K854604	Auto Mash	Dynatech Corp.	LIB	Class I	1985-12-06
K854603	Multi Mash 2000	Dynatech Corp.	LIB	Class I	1985-12-06
K854602	Mini Mash 2000	Dynatech Corp.	LIB	Class I	1985-12-06
K854567	Penicillin/streptomycin Solution	Mediatech, Inc.	KIT	Class I	1985-12-06
K854513	Empi, Nms/sue Cutaneous Electrode	Empi	GXY	Class II	1985-12-06
K854005	Dedo Suction Cannula	Dedo Manufacturer, Inc.	GEA	Class I	1985-12-06
K853738	Ortho Chlamydia Direct Detection (Fa) Test	Ortho Diagnostic Systems, Inc.	LJP	Class I	1985-12-06
K853419	Cleaning Kit Care & Cleaning of Tracheal T-Tube	Hood Laboratories	BTO	Class II	1985-12-06
K844050	Arthopor-Acetabular Component	Joint Medical Products Corp.	JDI	Class II	1985-12-06
K842663	Anti-Herpes Simplex Virus Type 1 or 2	Amico Lab, Inc.	GQO	Class II	1985-12-06
K842661	Anti-Cytomegalovirus Kit	Amico Lab, Inc.	GQI	Class II	1985-12-06
K842531	Amizyme-Hsv Types 1 & 2 Test Kits	Amico Lab, Inc.	GQO	Class II	1985-12-06
K842530	Amizyme-Ebv Test Kit	Amico Lab, Inc.	GNP	Class I	1985-12-06
K842529	Amizyme-Cmv Kit	Amico Lab, Inc.	GQI	Class II	1985-12-06
K854608	Analyzer Nova Stat Profile 2/Quality Control Mat.	Nova Biomedical Corporation	CHL	Class II	1985-12-05
K854585	Ultrazyme Plus & Systemate Ldh	Em Diagnostic Systems, Inc.	CFJ	Class II	1985-12-05
K854437	Churchill-H Vented IV Set	Churchill Corp.	FPA	Class II	1985-12-05
K854436	Churchill-H Scalp Vein Set	Churchill Corp.	FPA	Class II	1985-12-05
K854435	Churchill-H Non-Vented IV Set	Churchill Corp.	FPA	Class II	1985-12-05
K854392	Tobramycin Kit(fpia)fluorescence Polarization Immu	Windsor Laboratories, Inc.	LFW	Class II	1985-12-05
K854324	Pancoat T4 Coated Tube Radioimmunoassay Kit	Pantex, Div. Bio-Analysis, Inc.	CDX	Class II	1985-12-05
K854210	Terumo Sensibead Eia Colorimeter	Terumo Medical Corp.	JJQ	Class I	1985-12-05
K854172	i.v. Watch	Alltek, Inc.	FPB	Class II	1985-12-05
K854104	Immuchem V.i.p.(visual Indicated Pregnancy)	Immunchem Corp.	JHI	Class II	1985-12-05
K854057	Paragon Electrophoresis Sys Lipoprotein Reagent Te	Beckman Instruments, Inc.	JHO	Class I	1985-12-05
K853964	Computerized Radiation Treatment Planning Sys	Elekta Limited	LHN	Class II	1985-12-05
K853848	Respiratory Diagnostic Equipment Calibrator	Medical Graphics Corp.	BXW	Class I	1985-12-05
K853621	Replacement Pump Tubing	Shaban Mfg. Co.	JJE	Class I	1985-12-05
K853120	Additive Extension Syringe	Abbott Medical	FMF	Class II	1985-12-05
K852760	Lbk 1244 Delfia Hcg Kit	Lkb Instruments, Inc.	JHI	Class II	1985-12-05
K852266	Abbott Strep a P.s.d.	Abbott Medical	GTZ	Class I	1985-12-05
K854501	Ck(optimized) Reagent	Sigma Diagnostics, Inc.	CGS	Class II	1985-12-04
K854405	Pacesetter Systems Endocardial Small Fin Lead	Pacesetter Systems	DTB	Class III	1985-12-04
K854377	Hemotec Cv Whole Blood Coagulation Controls	Hemotec, Inc.	JOX	Class II	1985-12-04
K854376	Hemotec Citrated Whole Blood Coagulation Controls	Hemotec, Inc.	JPA	Class II	1985-12-04
K854310	Acs Indeflator (Modification)	Advanced Cardiovascular Systems, Inc.	DXT	Class II	1985-12-04
K854307	Kontron Defibrillator 7501	Kontron Instruments, Inc.	LDD	Class II	1985-12-04
K854261	Advanced Cardiovascular Systems Hemostatic Valves	Advanced Cardiovascular Systems, Inc.	DTL	Class II	1985-12-04
K854220	Pacesetter Sysems Endocardial Tri-Fix Lead	Pacesetter Systems	DTB	Class III	1985-12-04
K854184	In-Vitro Test Determination of Tobramycin	Clinical Data, Inc.	KLB	Class II	1985-12-04
K854136	Arrhythmia Review Station	Marquette Electronics, Inc.	DXG	Class II	1985-12-04
K854071	Polyflex 493-07 Endocardial Implantable Pac-Lead	Intermedics, Inc.	DTB	Class III	1985-12-04
K853850	Explorer	Mansfield Scientific, Inc.	DTB	Class III	1985-12-04
K853719	Transcutaneous Elect. Nerve Stimul-Myostim 410	Electro Therapeutic Devices Inc	GZJ	Class II	1985-12-04
K853718	Transcutaneous Electr. Nerve Stimul Myostim 804	Electro Therapeutic Devices Inc	GZJ	Class II	1985-12-04
K853695	Respiratory Syncytial Virus Id Reagent	Viromed Laboratories, Inc.	GQG	Class I	1985-12-04
K853521	Polyflex Implantable Pacing Lead-476-07	Intermedics, Inc.	DTB	Class III	1985-12-04
K853517	Lifeline Endocardial Unipolar Lead 483-08	Intermedics, Inc.	DTB	Class III	1985-12-04
K853405	Electrolyte Analyzer Sera-252	Horiba Instruments Incorporated	CHL	Class II	1985-12-04