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 1959 of 3531

510(k) clearances, page 1959 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K961536	Flexscope	Matrix Medica, Inc.	GDB	Class II	1996-09-18
K961049	Flex Needle	Lighthouse Medical, Inc.	FPA	Class II	1996-09-18
K961046	10B Arginine Broth	Remel Inc	JSM	Class I	1996-09-18
K960759	Gonopox Test Kit	Medtex Laboratories, Inc.	JSX	Class I	1996-09-18
K960754	Spectrum 5000 Q, 5000 M, 4000 Q, 4000 M	Mecta Corp.	QGH	Class II	1996-09-18
K960061	Storz D7108 Microscissors Handpiece/storz D7106 Microscissors Drive Tube	Storz Instrument Co.	HQE	Class II	1996-09-18
K953663	Cordis Webster T20 Diagnostic Deflectable Tip Catheter	Cordis Webster, Inc.	DRF	Class II	1996-09-18
K962541	Reflection Acetabular Reinforcement Rings	Smith & Nephew Richards, Inc.	JDJ	Class II	1996-09-17
K962467	Rv Pacing Lead	Abbott Medical	LDF	Class II	1996-09-17
K962393	Ksea Set for Endoscopic Assisted Intubation	Karl Storz Endoscopy-America, Inc.	GCM	Class II	1996-09-17
K962307	Rhyder Diagnostic Catheter	Fidus Medical Technology Corp.	DRF	Class II	1996-09-17
K961920	Cross Pin	Medicinelodge, Inc.	JDW	Class II	1996-09-17
K961745	Braun Percutaneous Introducer Set	B.Braun Medical, Inc.	DYB	Class II	1996-09-17
K961572	Versalok Screw Assembly (Proposed Name)	Wrightmedicaltechnologyinc	MNH	Class II	1996-09-17
K961526	Press-Fit Porous Shell	Encore Orthopedics, Inc.	LPH	Class II	1996-09-17
K961345	Domed Percutaneous Endoscopic Gastrostomy(p.e.g.) Feeding Tube	Applied Medical Technologies	KNT	Class II	1996-09-17
K961239	Depuy Sterile View Barrier Hood/gown with Hytrel	Depuy, Inc.	FYA	Class II	1996-09-17
K961186	Depuy Duraloc Cementless Acetabular Cup System	Depuy, Inc.	LPH	Class II	1996-09-17
K960984	Shp Hip System-Femoral Components/acetabular Components/modular Heads/centralizers	Zimmer GmbH	JDI	Class II	1996-09-17
K960942	Latex Patient Examination Glove	Siam Sempermed Corp., Ltd.	LYY	Class I	1996-09-17
K960851	Thermistor Cannula Style,single Element,adam Shell Thermistor Airflow Sensor	Pro-Tech Services, Inc.	BZQ	Class II	1996-09-17
K960647	Omega Total Hip System for Cemented Applications	Osteoimplant Technology, Inc.	JDI	Class II	1996-09-17
K952660	Braun Hemodialysis Catheter	B.Braun Medical, Inc.	MPB	Class II	1996-09-17
K952220	Meretek Breath Test for H.pylori Collection Kit	Meretek Diagnostics, Inc.	LYR	Class I	1996-09-17
K962971	Polypropylene Mesh (Various Sizes)	Davis & Geck, Inc.	FTL	Class II	1996-09-16
K962900	Self Retaining Male External Urinary Catheter	Hollister, Inc.	EXJ	Class I	1996-09-16
K962826	Medline Radiology-Diagnostic Kits	MEDLINE INDUSTRIES, LP - Northfield	LRO	Class II	1996-09-16
K962817	Drug Calibrator II	Dade Intl., Inc.	DKB	Class II	1996-09-16
K962506	[Specialized Tissue Aspirating Resectoscope (Star)]	Gynecare Innovation Center	FJL	Class II	1996-09-16
K962460	Eg-3800T, Video Gastroscope	Pentax Precision Instrument Corp.	FDS	Class II	1996-09-16
K962388	In the Ear Hearing Aid	Unique Hearing Technology, Inc.	ESD	Class I	1996-09-16
K962293	Endosonics Automatic Pull Back Device	Endosonics Corp.	ITX	Class II	1996-09-16
K961941	Liquichek Immunoassay Plus Control Catalog No. 360,361,362,363	Bio-Rad	JJY	Class I	1996-09-16
K961928	Biomedix i.v. Extension Line W/ Stopcock Model B50-102/B51-102	Biomedix Wai	FPA	Class II	1996-09-16
K961048	Olympus Mh-246R Balloon Sheath	OLYMPUS Corporation of the Americas	ODG	Class II	1996-09-16
K960503	Dantec Duet	Dantec Medical, Inc.	FEN	Class II	1996-09-16
K954427	Helping Hand	Kinetic Rehabilitation Instruments, Inc.	ITI	Class II	1996-09-16
K954426	CPR Life Mask Compact Barrier	Carefree Trading, Inc.	CBP	Class II	1996-09-16
K953238	Drager Micro Vent	Drager, Inc.	CBK	Class II	1996-09-16
K963275	Relisa Ena Single Well Screen Antibody Test System	IMMUNO CONCEPTS, NA, Ltd.	LLL	Class II	1996-09-13
K963267	Vancomycin Flex Reagent Cartridge	Dade Intl., Inc.	LEH	Class II	1996-09-13
K963088	Sheath, Electrosurgical Pencil	Aspen Laboratories, Inc.	GEI	Class II	1996-09-13
K963070	Venipuncture Kit	Miller Products and Services	FPA	Class II	1996-09-13
K962820	Carbamazepine Flex Reagent Cartridge	Dade Intl., Inc.	KLT	Class II	1996-09-13
K962819	Gentamicin Flex Reagent Cartridge	Dade Intl., Inc.	LCD	Class II	1996-09-13
K962818	Tobramycin Flex Reagent Cartridge	Dade Intl., Inc.	LCR	Class II	1996-09-13
K962671	Sta-Vwf Calibrator Kit	American Bioproducts Co.	GJT	Class II	1996-09-13
K962629	Document Ammonia, Ethanol, Lactate Calibrator	Casco Standards	JIX	Class II	1996-09-13
K962319	Neoprobe 1000 Gen 1C Portable Radioisotope Detector & Accessories	Neoprobe Corp.	IZD	Class I	1996-09-13
K961449	Tracheostomy Tubes Tracoe-Flex	Tracoe Medical GmbH	JOH	Class II	1996-09-13