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 2026-10-29, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 2544 of 3530

510(k) clearances, page 2544 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K897074	Model 215M Patient Simulator	Dynatech/Nevada, Inc.	DSI	Class II	1990-05-17
K896775	Pci Model 2041-B Telemetry Monitor	Accucore, Inc.	DSI	Class II	1990-05-17
K896338	Voss Disposable Coronary Bypass Flushing Cannula	voss medical products	DWF	Class II	1990-05-17
K896020	Extracorporeal Heat Exchanger He Series	Gish Biomedical, Inc.	DTR	Class II	1990-05-17
K902016	Modified Aor-Sullivan Protective Overglove	Aor-Sullivan	LYU	Class I	1990-05-16
K901696	Latex Condoms - Code No. 403, 406, 421 & 1033	Allercare/Nsl, Inc.	HIS	Class II	1990-05-16
K901669	Latex Condoms - Code No. 404, No. 424 & No. 1000	Allercare/Nsl, Inc.	HIS	Class II	1990-05-16
K901668	Latex Condoms - Code No. 402, Code No. 1028	Allercare/Nsl, Inc.	HIS	Class II	1990-05-16
K901667	Latex Condoms - Code No. 401, 421 & 1002	Allercare/Nsl, Inc.	HIS	Class II	1990-05-16
K901398	Latex Surgeon Gloves	Sinochem (USA), Inc.	KGO	Class I	1990-05-16
K900939	Spq Test System II for Fib (Serum Protein Quanti.)	Incstar Corp.	KQJ	Class II	1990-05-16
K897129	Condoms (Multiple Brands)	Sagami, Inc.	HIS	Class II	1990-05-16
K902004	Trobicin Susceptibility Powder	The Upjohn Co.	LOP	Class II	1990-05-15
K901591	Escort-Link (Model E3200)	Medical Data Electronics	DXH	Class II	1990-05-15
K901557	Umbilical Cord Clamp and Cutter	Microtek-Heritage, Inc.	HFW	Class II	1990-05-15
K901488	Lynx-Sm, Sclaer Dental Handpiece	Mti Precision Products	ELC	Class II	1990-05-15
K901450	Modified Label for Embria-Ck, Quick-Mb/micromi-Mb	Intl. Immunoassay Laboratories, Inc.	JHT	Class II	1990-05-15
K901396	Concept Inlay/onlay	Ivoclar North America, Inc.	EBF	Class II	1990-05-15
K901371	Aso-Cube(tm)	Difco Laboratories, Inc.	GTQ	Class I	1990-05-15
K901299	Celebrity-Carenza-Sungear-Summit Sunglasses	Sun Mark, Inc.	HQY	Class I	1990-05-15
K901239	Teledyne Getz's Disposable Prophy Angle	Teledyne Getz	EFB	Class I	1990-05-15
K901168	Non-Prescription Sunglasses	Renauld Intl., Ltd.	HQY	Class I	1990-05-15
K901060	Edentec Model 2000W System 700 Monitor	Edentec Corp.	DQA	Class II	1990-05-15
K901047	Sunglasses	Command Marketing Corp.	HQY	Class I	1990-05-15
K901017	Du Pont Analyst Analytical Test Rotor:chem-14,Cali	E.I. Dupont de Nemours & Co., Inc.	JFJ	Class II	1990-05-15
K900991	Sunpak Aqua Floss 2000 Cordless Personal Oral Jet	Tocad America, Inc.	EFS	Class I	1990-05-15
K900973	Visuwell(r) Chlamydia	Adi Diagnostics, Inc.	LJC	Class I	1990-05-15
K900935	Du Pont Linx Laser Imager W/the Linx Networking	E.I. Dupont de Nemours & Co., Inc.	LMD	Class I	1990-05-15
K900930	Spivey-Allen Orbital Floor Implant	Oculo Plastik, Inc.	HQX	Class II	1990-05-15
K900928	Cox Malar Eminence Implants	Oculo Plastik, Inc.	HQX	Class II	1990-05-15
K900927	Codere-Durette Orbital Floor Implant	Oculo Plastik, Inc.	HQX	Class II	1990-05-15
K900888	Lockbox	Pharmacia Deltec, Inc.	FRN	Class II	1990-05-15
K900887	Abbott Spectrum Automated Clinical Chem. Analyzer	Abbott Medical	CGZ	Class II	1990-05-15
K900883	Enzymun Test(r) Ft4 (Free Thyroxine)	Boehringer Mannheim Corp.	CEC	Class II	1990-05-15
K900841	Hemodialysis Transducer Protector	Mediflex Intl.	FIB	Class II	1990-05-15
K900802	Anti-Human Leu-3A (Cd4) Fitc	BD Becton Dickinson Vacutainer Systems Preanalytic	GKZ	Class II	1990-05-15
K900799	Comfort Acrylics Pliable Denture Liners & Splints	Comfort Acrylics, Inc.	EBI	Class II	1990-05-15
K900766	Epi Dent Toothbrush	Epi Mfg.	JEQ	Class I	1990-05-15
K900688	Varicella Zoster Igg Clin-Elisa Test Kit	Clinical Sciences, Inc.	LFY	Class II	1990-05-15
K900380	Medilase 5010 Endoscope Console	Medical Laser, Inc.	FET	Class II	1990-05-15
K900301	Novus Bonding Agent	The Hygenic Company, LLC	EBI	Class II	1990-05-15
K897011	Palfique Light-S Composite Resin	Tokuyama America Inc.	EBF	Class II	1990-05-15
K897010	Palfique Light Composite Resin	Tokuyama America Inc.	EBF	Class II	1990-05-15
K897009	Palfique Light Bonding Agent	Tokuyama America Inc.	KLE	Class II	1990-05-15
K896981	Tokuso Rebase	Tokuyama America Inc.	EBI	Class II	1990-05-15
K896980	Palfique Light Liner	Tokuyama America Inc.	EBI	Class II	1990-05-15
K896769	Interface Bonding System	Smile Horizons, Inc.	EBF	Class II	1990-05-15
K896481	Purebrush Ultraviolet Toothbrush Sanitizer	Purebrush Assoc.	MCF	Class I	1990-05-15
K896410	Cellognost Syphilis H	Behring Diagnostics, Inc.	GMT	Class II	1990-05-15
K896340	Biomer(r) F Composite Luting Cement	Dentsply Intl.	EMA	Class II	1990-05-15