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 2582 of 3530

510(k) clearances, page 2582 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K896008	Model 6500 Mercury Arc Light Source	Medical Dynamics, Inc.	GCP	Class II	1989-12-27
K896006	Dialysis Priming Sets Codes 5C4094 and 5C4095	Baxter Healthcare Corporation	KOC	Class II	1989-12-27
K896003	Latex Examination Gloves	Jiea Chao Ent. Co., Ltd.	LYY	Class I	1989-12-27
K895943	Normal and Abnormal Control Sera	Sclavo, Inc.	JJY	Class I	1989-12-27
K895884	Bandage Removal Strip	Kut-Guard, Inc.	KGX	Class I	1989-12-27
K895883	Beckman Ma Microalbumin Reagent Kit	Beckman Instruments, Inc.	JIQ	Class I	1989-12-27
K895865	Serene Wrap	Byron Medical	EFQ	Unclassified	1989-12-27
K895802	Non Constrained Total Shoulder System	Orthopaedic Medical Group, Inc.	KWT	Class II	1989-12-27
K895756	Mikro-Aquapurator	Mikro-Tek Laboratories	GBX	Class I	1989-12-27
K895755	Mikro-Lavage-1	Mikro-Tek Laboratories	GBX	Class I	1989-12-27
K895689	Lifeport Vascular Access Port	Strato Medical Corp.	LJT	Class II	1989-12-27
K895516	Cavity Drainage Catheterization Set, Cs-01600	Arrow Intl., Inc.	GBX	Class I	1989-12-27
K895465	Amdev Lytening 2Z Sodium/potassium/lithium Analyze	Baxter Healthcare Corporation	JIH	Class II	1989-12-27
K895426	Ambulatory Infusion Pump	Bionica, Inc.	FRN	Class II	1989-12-27
K895291	IV Dispesnsing Spike	The Medi-Dose Group	FPA	Class II	1989-12-27
K895290	Chemo-Spike Reconstitution Device	The Medi-Dose Group	FPA	Class II	1989-12-27
K895139	Clinistat Hdl Cholesterol Reagent Test	Kulzer GmbH	LBS	Class I	1989-12-27
K895012	E-Z-Em Vacuum Aspiration Syringe	E-Z-EM, Inc	GAA	Class I	1989-12-27
K894423	Acc.u.dial	Exocell, Inc.	JJQ	Class I	1989-12-27
K893461	Latex Examination Gloves	Zhum Heng Development, Ltd.	LYY	Class I	1989-12-27
K896768	Non-Prescription Sunglasses	Shairon Intl. Trade Co.	HQY	Class I	1989-12-26
K896716	Plastic Sunglasses	Bright Horizon Ent.	HQY	Class I	1989-12-26
K896685	Bausch & Lomb Frequent Replacement Case System	Bausch & Lomb Incorporated	LRX	Class II	1989-12-26
K895877	Ramclean Dental Vacuum Line Cleaner	Ramvac Corp.	EIA	Class I	1989-12-26
K895876	Ramvac Dental Vacuum System	Ramvac Corp.	EIA	Class I	1989-12-26
K895815	Microtek Total Ossicular Prothesis	Microbio-Medics, Inc.	ETA	Class II	1989-12-26
K895814	Microtek Piston & Wire Prostheses	Microbio-Medics, Inc.	ETB	Class II	1989-12-26
K897012	Scented or Scented Deodorized, Unscented Tampons	Playtex Family Products, Inc.	HIL	Class II	1989-12-22
K896994	Kotex Security Tampons (Several Type)	Kimberly-Clark Corporation	HEB	Class II	1989-12-22
K896989	Tampax Tampon	Tambrands Inc.	HEB	Class II	1989-12-22
K896511	Du Pont Xenolite(tm) Radiation Protection Apparel	E.I. Dupont de Nemours & Co., Inc.	KPY	Class I	1989-12-22
K896458	Aspect Gamma Camera	Digital Scintigraphics, Inc.	KPS	Class II	1989-12-22
K896370	Disp. Concentric Needle Electrode (Dcp-30, Dcp-45)	Chalgren Enterprises, Inc.	GXZ	Class II	1989-12-22
K896353	Ge Target Series 2	GE Healthcare	KPQ	Class II	1989-12-22
K896336	Model Spine Surveyor-Plus; Cat. #Acs-10A	Medical Advances, Inc.	LNH	Class II	1989-12-22
K896331	V2465p X-Ray Image Intensifier	Hamamatsu Photonics K.K.	JAA	Class II	1989-12-22
K896261	The Smithcot	Ram Marketing, Inc.	FPP	Class I	1989-12-22
K896030	Hewlett-Packard Model M1016a CO2 & M1017a Fi02	Hewlett-Packard Co.	CCK	Class II	1989-12-22
K895976	Tooth Shade Resin	G-C Intl. Corp.	EBF	Class II	1989-12-22
K895913	Standard Nebulizer Heater	Seamless Div., Professional Medical Products	CAF	Class II	1989-12-22
K895853	Sechrist Disposable Infant Breathing Circuit	Sechrist Industries Inc	BZO	Class I	1989-12-22
K895849	Respironics Vacuvest Respiratory Support System	Respironics, Inc.	BYT	Class II	1989-12-22
K895767	Original Tick Kit/1st Aid Kit	Tick Kit, Inc.	LRR	Not classified	1989-12-22
K895763	Isoflo and Isotec Intrauterine Pressure Monitoring	Healthdyne Cardiovascular, Inc.	KXO	Class II	1989-12-22
K895555	Modified Hi Chem Amylase Reagent (Product #88129)	Hichem Diagnostics	CJA	Class II	1989-12-22
K895125	Ceegraph	Bio-Logic Systems Corp.	GWQ	Class II	1989-12-22
K894889	Teca Neuromapper 386	Teca, Inc.	OLT	Class II	1989-12-22
K894691	Model Ao-800Pa CO2 Module	Nihon Kohden America Inc	CCK	Class II	1989-12-22
K894412	Radioscope or Mammoscope	Vision Ten, Inc.	LMA	Class II	1989-12-22
K894282	First Impression Tm	Coe Laboratories, Inc.	ELW	Class II	1989-12-22