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 3080 of 3528

510(k) clearances, page 3080 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K840654	Dialysis Admin. Set - i.v.	Cp Medical	KOC	Class II	1984-05-02
K840568	Active Life One-Piece Closed-End Pouch	Convatec, A Division of E.R. Squibb & Sons	EXB	Class I	1984-05-02
K840567	Active Life One-Piece Stoma Cap	Convatec, A Division of E.R. Squibb & Sons	EXB	Class I	1984-05-02
K840182	Renapak Concentrate Mixing Sys.	Renal Systems, Inc.	FKQ	Class II	1984-05-02
K834585	Celltrak-B	R & D Systems, Inc.	FRZ	Class II	1984-05-02
K834449	Hsv Antigen Elisa Kit	Ortho Diagnostic Systems, Inc.	LGC	Class II	1984-05-02
K834093	Perforator Bur	Treace Medical, Inc.			1984-05-02
K833567	Comfeel Protective Film	MEDLINE INDUSTRIES, LP - Northfield	EXB	Class I	1984-05-02
K833089	Cytomegalovirus Antibody Fluoro-Kit II	Clinical Sciences, Inc.	GQH	Class II	1984-05-02
K841070	Creatinine Reagent Set	Medical Specialties Inc.	JFY	Class II	1984-05-01
K841069	Serum Total Protein Reagent Set	Medical Specialties Inc.	CEK	Class II	1984-05-01
K841068	Urea Nitrogen Reagent Set	Medical Specialties Inc.	CDW	Class II	1984-05-01
K841067	Uric Acid Reagent Set	Medical Specialties Inc.	CDH	Class I	1984-05-01
K841066	Sgot-UV Reagent Set	Medical Specialties Inc.	CIT	Class II	1984-05-01
K841065	Sgot Reagent Set	Medical Specialties Inc.	CIQ	Class II	1984-05-01
K841064	Alkaline Phosphotase Reagent Set	Medical Specialties Inc.	CIO	Class II	1984-05-01
K841063	Albumin Reagent Set	Medical Specialties Inc.	CIX	Class II	1984-05-01
K841062	Triglyceride Reagent Set	Medical Specialties Inc.	CDT	Class I	1984-05-01
K841061	Phophorus Reagnet Set	Medical Specialties Inc.	CEO	Class I	1984-05-01
K841060	Sgpt Reagent Set	Medical Specialties Inc.	CKA	Class I	1984-05-01
K841059	Sgpt Reagent Set	Medical Specialties Inc.	CKD	Class I	1984-05-01
K841058	Ldh-UV Reagent Set	Medical Specialties Inc.	CFJ	Class II	1984-05-01
K841056	Hdl Precipitant Reagent Set	Medical Specialties Inc.	JHM	Class I	1984-05-01
K841055	Glucose Enzymatic Reagent Set	Medical Specialties Inc.	CGA	Class II	1984-05-01
K841054	Direct Glucose Reagent Set	Medical Specialties Inc.	CGE	Class II	1984-05-01
K841053	Cholesterol Reagent Set Enzymatic	Medical Specialties Inc.	CHH	Class I	1984-05-01
K841052	Cholesterol Reagent Set	Medical Specialties Inc.	CHD	Class I	1984-05-01
K841051	Serum Calcium Reagent Set	Medical Specialties Inc.	CIC	Class II	1984-05-01
K841050	Total Bilirubin Reagent Set	Medical Specialties Inc.	CIG	Class II	1984-05-01
K841049	Uric Acid Reagent Set Enzymatic	Medical Specialties Inc.	KNK	Class I	1984-05-01
K841023	Coated Tube Hcg Immunoassay Hcg	Ventrex Laboratories, Inc.	JHI	Class II	1984-05-01
K841014	Weighted Feeding Tube W/pre-Inserted	Ethox Corp.	KNT	Class II	1984-05-01
K841010	Surgical Hooks, Various	Premier Dental Products Co	GDG	Class I	1984-05-01
K841009	Surgical Retractors-Various	Premier Dental Products Co	GAD	Class I	1984-05-01
K840996	Urine Analyzer System	Kyoto Diagnostics, Inc.	KQO	Class I	1984-05-01
K840917	Urinary Monitoring Sys 240	Vital Metrics, Inc.	KNX	Class II	1984-05-01
K840848	Biosure	Helena Laboratories, Corp.	JJW	Class I	1984-05-01
K840802	Dia Thrombin Dia Plastin	Diatech, Inc.	GJS	Class II	1984-05-01
K840563	Rx C & B 20	Jeneric Ind.	EJS	Class II	1984-05-01
K840561	Rx Elan	Jeneric Ind.	EJS	Class II	1984-05-01
K840405	Bosworth Dent-All	Harry J. Bosworth Co.	EBI	Class II	1984-05-01
K840304	Category 17-Microbiology Devices	Imm Enterprises, Ltd.	HTD	Class I	1984-05-01
K840244	Bioceram Zest Plant	Zest Anchors LLC	DZE	Class II	1984-05-01
K834490	Gelscan Software 2190	Lkb Instruments, Inc.	JQP	Class I	1984-05-01
K834383	Dual-Lumen Long Term Central Venous Cat	Burron Medical Products, Inc.	LJS	Class II	1984-05-01
K834332	Boundary Single-Use Gowns	Procter & Gamble Mfg. Co.	FYA	Class II	1984-05-01
K834299	Long Term Central Venous Access Cath	Burron Medical Products, Inc.	LJS	Class II	1984-05-01
K841581	Unifilter Anesthesia & Respiratory Filt	Dupaco, Inc.	CAH	Class II	1984-04-30
K841546	Communi-Trach Tube	Implant Technology, Inc.	BTO	Class II	1984-04-30
K841522	Calcium Chloride	Diatech, Inc.	GGW	Class II	1984-04-30