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 2844 of 3529

510(k) clearances, page 2844 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K863442	Ubi Magiwel(tm) Lh Quantitative & Qualitative	United Biotech	CEP	Class I	1987-02-04
K862906	Teca/medelec as-10 Sensor	Teca, Inc.	GWJ	Class II	1987-02-04
K862610	Ultra-Vue Spinal Type Biopsy Needle	BD Becton Dickinson Vacutainer Systems Preanalytic	FMI	Class II	1987-02-04
K862514	Omniplus Freq Double Nd:yag Photosurg Sys/neuro	Laserscope	GEX	Class II	1987-02-04
K862352	Acculator 487E	Accu Science Corp.	GZJ	Class II	1987-02-04
K870141	Uresil T-System Bone Screws	Uresil, LLC	HWC	Class II	1987-02-03
K870126	Femur Wrench	Mizuho Orthopedic Systems Inc	GEG	Class I	1987-02-03
K870102	Tupper Trolley	Mizuho Orthopedic Systems Inc	HST	Class I	1987-02-03
K864803	Gc-Lect(tm)	BD Becton Dickinson Vacutainer Systems Preanalytic	JTY	Class II	1987-02-03
K864619	Caps Low Level Detector & Detector/bubble Monitor	Shiley, Inc.	KRL	Class II	1987-02-03
K864605	Vaplok	Bear Medical Systems, Inc.	CAD	Class II	1987-02-03
K864588	Penlon Circle System	Bear Medical Systems, Inc.	CAI	Class I	1987-02-03
K864170	Leeco Vis-Cube Strep a (Eia)	Leeco Diagnostics, Inc.	GTZ	Class I	1987-02-03
K863227	Cook-Vpi Continence Cuff	Cook Incorporated	FHA	Class I	1987-02-03
K863156	Teca/medelec Audiostar	Teca, Inc.	GWJ	Class II	1987-02-03
K863100	Cen Sta Mon Ac/dc Alarm Central Acces Alarm Recor	Honeywell, Inc.	DPS	Class II	1987-02-03
K862462	Lifescope 6, Oec-6120 Portable Patient Monitor Rec	Nihon Kohden America Inc	BZQ	Class II	1987-02-03
K862402	Ott Disinfector for Flexible Endoscopes	Medivators Inc	NVE	Class II	1987-02-03
K862383	Modified Model Bia-103 Body Composition Analyzer	Rjl Systems, Inc.	DSB	Class II	1987-02-03
K862226	Dialog Models 748, 748K and 748T Pulse Generators	Pacesetter Systems	DXY	Class III	1987-02-03
K861987	2120 Non-Invasive Blood Pressure Monitor W/cuff	GE Healthcare	DXN	Class II	1987-02-03
K861582	Injet-100, Fluid Injector	Injet Medical Products, Inc.	KZE	Class II	1987-02-03
K870032	Revised T-Scan System	Sentek, Inc.	EFH	Class I	1987-02-02
K865020	Sera-Tek Thyroglobulin Antibody Test	Miles Laboratories, Inc.	DDC	Class II	1987-02-02
K864663	Pathfinder Chlamydia Culture Confirmation System	Kallestad Diag, A Div. of Erbamont, Inc.	LJP	Class I	1987-02-02
K864657	Atl's Ultramark 6 Ultrasound System	Advanced Technology Laboratories, Inc.	DXK	Class II	1987-02-02
K864604	Ebv Vca Igm Antibody Assay Kit	Granbio, Inc.	LJN	Class I	1987-02-02
K864548	Alferr Tibc Tube	Benchmark Reagents	JQE	Class I	1987-02-02
K864524	Sperm Select(tm)	Pharmacia, Inc.	MQL	Class II	1987-02-02
K864493	Revised Resistant 5 Mic Panel	Pasco Laboratories, Inc.	JWY	Class II	1987-02-02
K864452	Delfia(tm) Triiodothyronine (T3) Kit	Lkb Instruments, Inc.	CDP	Class II	1987-02-02
K864449	Digoxin/ria Kit Coated Tube Radioimmunoassay Kit	Canadian Bioclinical, Ltd.	DPO	Class II	1987-02-02
K864443	Egg-Top Torp and Egg-Top Porp	Richards Medical Co., Inc.	ETA	Class II	1987-02-02
K864420	Cmv Microassay	Diamedix Corp.	GQI	Class II	1987-02-02
K864400	Extra Strong Condom	Ansell, Inc.	HIS	Class II	1987-02-02
K864396	Lymphocyte Maintenance Medium	Bioclinical Laboratory Services, Inc.	KIT	Class I	1987-02-02
K864347	Indirect Immunofluorescent Antibody Assay/ Ebv-Vca	Granbio, Inc.	GNP	Class I	1987-02-02
K864315	Cytotech Rubella Igg Enzyme Immunoassay	Cytotech, Inc.	LFX	Class II	1987-02-02
K863776	Microdilution Mic Panels	American Micro Scan	JWY	Class II	1987-02-02
K862859	Eub 151 Ultrasound System/eub 150 Ultrasound	Biosound, Inc.	DXK	Class II	1987-02-02
K861515	Osteopak Bmd (Bone Mineral Densitometer)	Siemens Gammasonics, Inc.	KGI	Class II	1987-02-02
K861123	The Golden Quad Test (Cmv)	Microbiological Research Corp.	GQI	Class II	1987-02-02
K861122	The Golden Quad Test (Toxo)	Microbiological Research Corp.	LJK	Class II	1987-02-02
K861121	The Golden Quad Test (Ebv)	Microbiological Research Corp.	GNP	Class I	1987-02-02
K861120	The Golden Quad Test (Hsv)	Microbiological Research Corp.	GQO	Class II	1987-02-02
K864958	Alpha II Diagnostic X-Ray	Ausonics Pty, Ltd.	IZH	Class II	1987-01-30
K864903	Mod. 4006 Adu., Oxy. Delive.-Oral CO2 Sam. Cannula	Salter Labs	CCK	Class II	1987-01-30
K864837	Modified Mainframe of Model 902 Mobile C-Arm	Oec-Diasonics, Inc.	JAA	Class II	1987-01-30
K864408	EMG-1, Motor Nerve Monitor	Algotek, Inc.	IKN	Class II	1987-01-30
K864225	Angiomed Ureteral D&m Sets/ureteroscopy Guid Stent	Angiomed U.S., Inc.	FAD	Class II	1987-01-30