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 3062 of 3528

510(k) clearances, page 3062 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K842604	Emerson Motion Bed 6-Ms & 6-Me	J. H. Emerson Co.	IKZ	Class II	1984-07-20
K842587	Gnc Plus	Vitek Systems, Inc.	JTO	Class I	1984-07-20
K842553	Chesebrough-Pond's Reusable Urinary Leg	Chesebrough-Pond'S U.S.A. Co.	KNX	Class II	1984-07-20
K842510	Glucose Assay Kit-Hexokinase	Diagnostic Chemicals, Ltd. (USA)	CFR	Class II	1984-07-20
K842509	Calcium Assay Kit	Diagnostic Chemicals, Ltd. (USA)	CIC	Class II	1984-07-20
K842508	Creatine Kinase Assay Kit Nac	Diagnostic Chemicals, Ltd. (USA)	CGS	Class II	1984-07-20
K842507	Lactate Dehydrogenase Assay Kit	Diagnostic Chemicals, Ltd. (USA)	CFJ	Class II	1984-07-20
K842368	Sickle Cell Reagent Set	Livonia Diagnostics, Inc.	GHM	Class II	1984-07-20
K842316	Critikon Triple-Lumen Central Venous	Critikon Company, LLC	DQY	Class II	1984-07-20
K842307	General Diag. Cefonicid 30Mcg Antimic	General Diagnostics	JTN	Class II	1984-07-20
K842279	Bectec Nr-660 Bacterial Detect Sys	BD Becton Dickinson Vacutainer Systems Preanalytic	JTA	Class I	1984-07-20
K842271	Electrode, Surface EEG Electrode	Durden Enterprises, Inc.	GXY	Class II	1984-07-20
K842268	Vacupulse Vacuum Unit	I-Rep, Inc.	IPF	Class II	1984-07-20
K842252	Cefonicid 30 Mcg Sensi-Disc	BD Becton Dickinson Vacutainer Systems Preanalytic	JTN	Class II	1984-07-20
K842234	New Jersey Femoral Stem	Endomedics, Inc.	KWL	Class II	1984-07-20
K842233	New Jersey Femoral Resurfacing Component	Endomedics, Inc.	KXA	Class II	1984-07-20
K842202	New Jersey Acetabular Component &	Endomedics, Inc.	JDI	Class II	1984-07-20
K842151	Chlamydiae Immunoperoxidase Test Kit	Bartels Immunodiagnostic Supplies, Inc.	LKH	Class I	1984-07-20
K842143	Bent Winged Mini-Vol Infusion Set	Med Fusion Systems, Inc.	FPA	Class II	1984-07-20
K842023	Temp. & Gsr Biofeedback Device	Electronics Research & Production	HCC	Class II	1984-07-20
K842022	EEG Biofeedback Device	Electronics Research & Production	HCC	Class II	1984-07-20
K842021	EEG Biofeedback Device Accessory	Electronics Research & Production	HCC	Class II	1984-07-20
K842506	Glucose-Trinder-Adday Kit	Diagnostic Chemicals, Ltd. (USA)	CGA	Class II	1984-07-19
K841957	Bovine Factor Xa-Human Factor Xa	Haemachem, Inc.	GGP	Class II	1984-07-19
K841956	Bovine Thrombin, Human Thrombin	Haemachem, Inc.	GJA	Class II	1984-07-19
K841953	Ultra Shield Briefs	Ipco Corp.	EYQ	Class I	1984-07-19
K841942	Segura Basket	Van-Tec, Inc.	FFL	Class II	1984-07-19
K841877	EEG Electrode Pad	Neurologics, Inc.	GXY	Class II	1984-07-19
K841819	Corpak Foley Cath Tray W/16fr. Teflon	Corpak Co.	KOD	Class II	1984-07-19
K841708	Meloy Immunostat Monoclonal Factor VIII	Meloy Laboratories, Inc.	GGP	Class II	1984-07-19
K841678	Sterile, Foley Catheters W/ptfe Coat	Abco Dealers, Inc.	KOD	Class II	1984-07-19
K841556	Heart - Aid Als, 95	Cardiac Resucitator Corp.	LDO	Class II	1984-07-19
K841384	Proxima 1 Ph Monitor	American Endoscopy, Inc.	FFT	Class I	1984-07-19
K841331	Olympus Kc-10 Mobile Disinfec-Stat	Keymed, Inc.	NZA	Class II	1984-07-19
K840649	Danam Elec. Sa-1000	Danam Electronics	GKL	Class II	1984-07-19
K840208	Code 17-Endoscope Deodorant	Knox Laboratories	FEB	Class II	1984-07-19
K833270	Astron 77 Injection Denture Resin	Astron Dental Corporation	EBI	Class II	1984-07-19
K842317	Signal Electronic Clinical Thermometer	Yukosha Co., Inc.	FLL	Class II	1984-07-18
K842246	Uric Acid Assay Kit	Diagnostic Chemicals, Ltd. (USA)	KNK	Class I	1984-07-18
K842245	Aspartate Aminotransferase Assay Kit	Diagnostic Chemicals, Ltd. (USA)	CIT	Class II	1984-07-18
K842244	Lactate Denydro Genase Assay Kit	Diagnostic Chemicals, Ltd. (USA)	CFJ	Class II	1984-07-18
K842243	Alkaline Phosphatase Assay Kit	Diagnostic Chemicals, Ltd. (USA)	CJE	Class II	1984-07-18
K842242	Urea Assay Kit	Diagnostic Chemicals, Ltd. (USA)	CDQ	Class II	1984-07-18
K842241	Alanine Aminotransferase Assay Kit	Diagnostic Chemicals, Ltd. (USA)	CKA	Class I	1984-07-18
K842199	Elec. Digital Thermometer Mt-20 & 30	Sharp Electronics Corp.	FLL	Class II	1984-07-18
K842153	Ultrasound Transmission Gel	Wpc Brands, Inc.	IYO	Class II	1984-07-18
K842132	Tycos Self-Check/digital Fever Thermo	Sybron Corp.	FLL	Class II	1984-07-18
K842090	Rhino-Larynx Stroboscope Type 4914	Bruel & Kjaer Industri A/S	EQL	Class I	1984-07-18
K842080	Abbott Lifecare 1050 Controller	Abbott Medical	LDR	Class II	1984-07-18
K842027	Ivac 3080 Enteral Feeding Pump	Y	FRN	Class II	1984-07-18