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 1919 of 3531

510(k) clearances, page 1919 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K970044	Aurofluid 22	Metalor Dental USA Corp.	EJS	Class II	1997-03-05
K970002	Sterile Water Pump	Micro Motors, Inc.	EIA	Class I	1997-03-05
K965155	Latex Exam Gloves	P.T. Irama Dinamika Latex	LYY	Class I	1997-03-05
K964997	S-Scort (2500)	Sscor	BTA	Class II	1997-03-05
K964966	V-Cath	Hdc Corp.	FOZ	Class II	1997-03-05
K964220	Replace Titanium Implant System	Steri-Oss, Inc.	DZE	Class II	1997-03-05
K963947	Epilaser Normal Mode Ruby Laser	Spectrum Medical Technologies, Inc.	GEX	Class II	1997-03-05
K963198	Ps-41 6M Patient Simulator	Metron U.S., Inc.	DPS	Class II	1997-03-05
K960373	Biojector 2000 Model 1B02000	Bioject, Inc.	KZE	Class II	1997-03-05
K970125	Noah Monitoring Electrode System	Contour Medical Technology, Inc.	DRX	Class II	1997-03-04
K970105	Riwo Cut-Morcellator Existing of Knife/cutting Sleeve/protection Sleeve/claw Grasping Forceps	Richard Wolf Medical Instruments Corp.	HET	Class II	1997-03-04
K970101	James Alex Sunglasses	D&K Stores, Inc.	HQY	Class I	1997-03-04
K970047	Phased Array Transducer - - Psk-20Ct	Toshiba America Medical Systems, In.C	ITX	Class II	1997-03-04
K965229	Imager Torque Catheter	Boston Scientific Corporation	KOD	Class II	1997-03-04
K965176	Pilling Weck 2 Piece Take-Apart Instruments	Pilling Weck Group	OCZ	Class II	1997-03-04
K965059	Cpi, Maxi-Vac(6480),thomas Industries, Medi-Pump(1240/1242/1243)	Thomas Industries	BTA	Class II	1997-03-04
K965030	Brannon Arterio-Venous Portsyringe	Vascular Logics, Inc.	FMF	Class II	1997-03-04
K965023	Choice Pt Plus Ptca Guide Wire and Choice Pt Vision Ptca Guide Wire	Scimed Life Systems, Inc.	DQX	Class II	1997-03-04
K964879	Pneumatic Arthroscopy Pulsed Irrigator System Model 0027030 and Battery Arthroscopy Pulsed Irrigator System	Davol Inc., Sub. C.R. Bard, Inc.	HRX	Class II	1997-03-04
K964855	Expandacell Eye Spear, Eye Wick, Wick Drain and Corneal Shield	Summit Medical, LLC	HOZ	Class II	1997-03-04
K964806	Md-1835	Fischer Imaging Corp.	IXL	Class II	1997-03-04
K964589	Flexilog 3000	Oakfield Instruments, Ltd.	KLA	Class II	1997-03-04
K964046	Dentsply Precision Torque System	Dentsply Intl.	DZE	Class II	1997-03-04
K963257	Peripherally Inserted Medline Catheter	Arrow Intl., Inc.	LJS	Class II	1997-03-04
K962755	Stryker Encore Sterilizer	Stryker Corp.	FLE	Class II	1997-03-04
K961661	Oximetrix 4 Computer System	Abbott Medical	DXG	Class II	1997-03-04
K954676	Nipro Arterial & Venous Blood Tubing Set for Hemodialysis	Nissho Corp.	KOC	Class II	1997-03-04
K952567	Autostattmii Anti-Dsdna	Cogent Diagnotics, Ltd.	LRM	Class II	1997-03-04
K930683	Eztest-Gas	Sgm Biomedical, Inc.	FRC	Class II	1997-03-04
K970527	Abbott Hcg Serum Controls	Abbott Medical	JJX	Class I	1997-03-03
K970393	Thyroid Stimulating Hormone Method	Dade Chemistry Systems, Inc.	JLW	Class II	1997-03-03
K970336	Mmb Calibrator	Dade Chemistry Systems, Inc.	JIT	Class II	1997-03-03
K964871	Biosearch Syring Flushing/cleaning Pump for Biosearch Endoscopic Instruments	Biosearch Medical Products, Inc.	FEB	Class II	1997-03-03
K964860	Mark 20 and Mark 25 Hand Engine Controller	Bell Intl., Inc.	EBW	Class I	1997-03-03
K964852	Radiacare Oral Wound Rinse	Carrington Laboratories, Inc.	OLR	Unclassified	1997-03-03
K964698	Safetex Combination Blood (Alcohol, Ethyl) / Urine Collection and Transport Kit	Andwin Scientific	JKA	Class II	1997-03-03
K964168	Procedure Specific Kits	Sage Products LLC	FXX	Class II	1997-03-03
K964014	Kenlor H. Pylori Control Serum	Kenlor Industries, Inc.	LYR	Class I	1997-03-03
K963522	Imz 2000 Interlock 12/3 - Screw	Imz, GmbH	DZE	Class II	1997-03-03
K963495	Imz 2000 Interlock 12/3 - Cylinder Dental Implant System	Imz, GmbH	DZE	Class II	1997-03-03
K963318	Legionella Igg/igm Elisa Test System	Armkel, LLC	LHL	Class II	1997-03-03
K963079	Canon Tx-10 Tonometer	Canon Medical Components U.S.A., Inc.	HKX	Class II	1997-03-03
K962479	Synermed Ise Reagents	Synermed, Inc.	CGZ	Class II	1997-03-03
K970351	Global Taper Spectron Hip Stems	Smith & Nephew, Inc., Orthopaedic Div.	JDI	Class II	1997-02-28
K970337	Ha Global Taper (Gt) Tapered Hip Stem	Smith & Nephew, Inc., Orthopaedic Div.	MEH	Class II	1997-02-28
K970040	Spine-Tech Bone Harvester	Spine-Tech, Inc.	HWE	Class I	1997-02-28
K970023	Mednext Surgical Bur	Mednext, Inc.	HWE	Class I	1997-02-28
K965241	Bipolar Suction Coagulator	Kirwan Surgical Products, LLC	GEI	Class II	1997-02-28
K965098	Intramedullary Nail System	Zimmer GmbH	HSB	Class II	1997-02-28
K965056	Osteonics Screw Hole Plugs	Osteonics Corp.	JDK	Class II	1997-02-28