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 2026-11-05, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,132 of the 176,529 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	2,732

176,529 records, page 2024 of 3531

510(k) clearances, page 2024 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K954656	Roche Control Serum P	Roche Diagnostic Systems, Inc.	JJY	Class I	1995-12-21
K954655	Roche Control Serum N	Roche Diagnostic Systems, Inc.	JJY	Class I	1995-12-21
K954619	Cordguard II	Utah Medical Products, Inc	KNA	Class II	1995-12-21
K954600	Microstaar Injector Models Msi-Td & Msi-Pd (Modification)	Staar Surgical AG	KYB	Class I	1995-12-21
K954581	Arc Series	Continental X-Ray Corp.	IZI	Class II	1995-12-21
K954574	Pure Advantage Nitrile Hypoallergenic Patient Examination Gloves	Tillotson Healthcare Corp.	LZA	Class I	1995-12-21
K954573	Pure Advantage Powder Free Nitrile Hypoallergenic Patient Examination Gloves	Tillotson Healthcare Corp.	LZA	Class I	1995-12-21
K954456	Thermoplastic Shield	Medtec LLC	KPY	Class I	1995-12-21
K954442	Sterile Isotonic Saline & Sterile Water	Medcare Custom Packaging, Inc.	JOL	Class II	1995-12-21
K954395	Carto System	Biosense, Ltd.	DQK	Class II	1995-12-21
K954390	Cordis Wester Star Catheter	Cordis Webster, Inc.	DRF	Class II	1995-12-21
K953814	Otoscape	Soundscape Technologies, Inc.	EWO	Class II	1995-12-21
K953486	Mit One Step Pregnancy Test	3c Diagnostics, Inc.	JHI	Class II	1995-12-21
K953101	Paragon Implant System	Core-Vent Bio-Engineering, Inc.	DZE	Class II	1995-12-21
K952606	Targett Patch	Cutting Edge Technologies, Inc.	KGX	Class I	1995-12-21
K952108	Exl-15Dp & 20-Dp Linac	Mitsubishi Intl. Corp.	IYE	Class II	1995-12-21
K951073	Cd3 Tri-Color/cd4 R-Pe/cd8 Fitc Monoclonal Antibody Combination	Caltag Laboratories, Inc.	GKZ	Class II	1995-12-21
K950918	Cd3 Fitc/cd4 R-Pe Monoclonal Antibody Combination	Caltag Laboratories, Inc.	GKZ	Class II	1995-12-21
K950917	Cd3 Fitc/cd8 R-Pe/cd45 Tri-Color Monoclonal Antibody Combination	Caltag Laboratories, Inc.	GKZ	Class II	1995-12-21
K950916	Cd3 Fitc/cd8 R-Pe Monoclonal Antibody Combination	Caltag Laboratories, Inc.	GKZ	Class II	1995-12-21
K946074	Alderson Brest Dosimetry System	Radiology Support Devices, Inc.	IYE	Class II	1995-12-21
K945268	Optus Bronchoscopes	Optus, Inc.	EOQ	Class II	1995-12-21
K940061	Polymedic Spinal Needle and Introducer	Techniques Medicales de Navaree	BSP	Class II	1995-12-21
K955300	Total Bilirubin Procedure	Data Medical Associates, Inc.	CIG	Class II	1995-12-20
K955155	Document Tdm Ultra Unassayed Control	Casco Standards	DIF	Class I	1995-12-20
K955097	Amerlite Mab Ft4 Assay	Kodak Clinical Diagnostics, Ltd.	CEC	Class II	1995-12-20
K955086	Test, Rheumatoid Factor	Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, LLC	DHR	Class II	1995-12-20
K954853	Auto Suture Suture Closure	United States Surgical, A Division of Tyco Healthc	GCJ	Class II	1995-12-20
K954812	Lyfo(tm) Differiental Disk-Pyr	Microbiologics, Inc.	JTO	Class I	1995-12-20
K954657	Wako Autokit Apo B	FUJIFILM Healthcare Americas Corporation	DFC	Class II	1995-12-20
K954515	Enzyme Linked Immunoabsorbent Assay, Rubella	Pyramid Biological Corp.	GOM	Class II	1995-12-20
K954434	Olympic Infant Thermometer	Olympic Medical Corp.	FLL	Class II	1995-12-20
K954296	Bagright Resuscitator	Medical Marketing Concepts	BTM	Class II	1995-12-20
K954150	Ventilator, Emergency, Manual (Resuscitator)	Green Field Medical Sourcing, Inc.	BTM	Class II	1995-12-20
K953767	Prosys Bedside Drainage Bag	Convatec, A Division of E.R. Squibb & Sons	FAQ	Class I	1995-12-20
K953608	Noprofile Olbert Catheter System Balloon Dilatation Catheter	Meadox Medicals, Div. Boston Scientific Corp.	LIT	Class II	1995-12-20
K953569	Courier Balloon Dilatation Catheter	Boston Scientific Corporation	LIT	Class II	1995-12-20
K951718	Hm-Spiro	Hill-Med, Inc.	BZG	Class II	1995-12-20
K951495	Access Toxo Igg Assay on the Access Immunoassay System	Bio-Rad Laboratories Inc.	LGD	Class II	1995-12-20
K950919	Cd3 Fitc/cd4 R-Pe/cd45 Tri-Color Monoclonal Antibody Combination	Caltag Laboratories, Inc.	GKZ	Class II	1995-12-20
K946337	It-727 (Also Known as It-610, It-600 and Dynaphor II	Skylark Device Co., Ltd.	EGJ	Class II	1995-12-20
K943307	3D Surgical Endoscopy System for General Surgery	OLYMPUS Corporation of the Americas	GCJ	Class II	1995-12-20
K943304	3D Surgical Endoscopy System for Urology	OLYMPUS Corporation of the Americas	FCG	Class II	1995-12-20
K955359	Cyber III Option Um, Uc312, Uc10, Ucic	Qualitone	ESD	Class I	1995-12-19
K955322	Protec X-Ray Detectable Gauze Sponge	Derivados de Gasa, S.A. de C.V.	GDY	Class I	1995-12-19
K955321	Protec Gauze Sponge	Derivados de Gasa, S.A. de C.V.	EFQ	Unclassified	1995-12-19
K954899	Rigid Neuroview Endoscope	Neuro Navigational Corp.	GWG	Class II	1995-12-19
K954511	Go Intramedullary Nail Locking Screw	Genesis Orthopedics, Inc.	HWC	Class II	1995-12-19
K954398	Insemi-Cath II	Cook Incorporated	MFD	Class II	1995-12-19
K954327	Medox Champion Compact Nebulizer	Medox Corp.	CAF	Class II	1995-12-19