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 1393 of 3531

510(k) clearances, page 1393 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K040795	Multicore Hb; Multicore Flow	Ivoclar Vivadent, Inc.	EBF	Class II	2004-05-17
K040779	Restore Wound Cleanser	Hollister, Inc.	KMF	Class I	2004-05-17
K040733	Elecsys Troponin T Stat Test	Roche Diagnostics GmbH	MMI	Class II	2004-05-17
K040652	Vue 100 Ultrasound Imaging System	Mobilsonic, Inc.	IYO	Class II	2004-05-17
K040623	Ams Perigee System	American Medical Systems, Inc.	OTP	Class III	2004-05-17
K040464	Amedica Drug Screen Thc/coc, Op1300, Ppx, Oxy, Bar/bzo Test	Amedica Biotech, Inc.	LDJ	Class II	2004-05-17
K040390	Stryker Urology and Gynecology Hardware System	Stryker Corp.	HIH	Class II	2004-05-17
K040389	Coonrad/morrey Elbow Cement Restrictor	Zimmer GmbH	JDC	Class II	2004-05-17
K040388	Next Generation Salem Sump	Kendall	FEG	Class II	2004-05-17
K033869	Contreet Foam Cavity Dressing with Silver, Model 9628 (2X4 in.)	MEDLINE INDUSTRIES, LP - Northfield	FRO	Unclassified	2004-05-17
K033747	Ramp Ck-Mb Assay	Response Biomedical Corp.	JHX	Class II	2004-05-17
K033745	Ramp Troponin I Assay	Response Biomedical Corp.	MMI	Class II	2004-05-17
K033566	Micromedic Drugs of Abuse Panel Test (9), Catalog Number 07Rd-7062	Rapid Diagnostics, Inc.	DKZ	Class II	2004-05-17
K041185	Torso Array Coil, Model 558Ge-64	Igc-Medical Advances, Inc.	MOS	Class II	2004-05-14
K041145	Modification to E-Scan Xq MRI System	Esaote S.p.A.	MOS	Class II	2004-05-14
K041137	Newtom 3G Qr-Dvt 9000	Aperio Services, LLC	OAS	Class II	2004-05-14
K041071	Bd Vacutainer Trace Element Serum Plus Tube and Bd Vacutainer Trace Element K2edta Plus Tube, Models 368380/368381	Becton Dickinson & Co	JKA	Class II	2004-05-14
K041028	Crown Delta Hydrophilic Impression Material	Crown Delta Corp.	ELW	Class II	2004-05-14
K041027	Digital Radiography System with Flat Panel Detector, Model Dfp8000d	Toshibamedical Systems Corporation	IZI	Class II	2004-05-14
K040962	Modification to Cd Horizon Spinal System	Medtronic Sofamor Danek	KWQ	Class II	2004-05-14
K040810	Varelisa Histone Antibodies, Model 16496	Pharmacia Deutschland GmbH	LJM	Class II	2004-05-14
K040716	Bd Phoenix Automated Microbiology System-Penicillin (Gp) 0.0625-32 Ug/ml	Becton Dickinson & Co	LON	Class II	2004-05-14
K040666	Step-Tip Chronic Hemodialysis Catheter	Arrow International LLC (subsidiary of Teleflex Incorporated)	MSD	Class II	2004-05-14
K040587	Mini Gamma Camera, Model Mgc-500	Acrorad Co., Ltd.	IYX	Class I	2004-05-14
K040504	Bardex, Lubri-Sil and Lubri-Sil Ic All-Silicone Foley Catheters	C.R. Bard Inc	EZL	Class II	2004-05-14
K040406	Polymer Coated, Chlorinated, Powder-Free Latex Examination Gloves with Protein Labeling (Less Than 50 Ug/g per Glove)	Shun Thai Rubber Gloves Industry Public Co., Ltd.	LYY	Class I	2004-05-14
K040384	Mydon C	Wavelight Laser Technologie AG	GEX	Class II	2004-05-14
K040174	Bilirubin Assay on the Omni S Analyzer	Roche Diagnostics GmbH	MQM	Class I	2004-05-14
K040017	Abc Caudal and Cranial Extension Plate (E-Plate)	Aesculap Inc	KWQ	Class II	2004-05-14
K033957	Infinity Modular Monitors Vf4 Modifications with Scio, Models Delta, Delta Xl, Kappa, Sc 8000, Sc 7000, Sc 9000Xl	Draeger Medical Systems, Inc.	MHX	Class II	2004-05-14
K033316	Table Tilt Device	Brainlab, Inc.	JAI	Class II	2004-05-14
K032761	Kmc-950 C-Arm Mobile System	United Radiology Systems, Inc.	OWB	Class II	2004-05-14
K030941	Aequalis Reversed Shoulder Prosthesis	TORNIER Inc.	PHX	Class II	2004-05-14
K030869	Bitestrip	S.L.P., Ltd.	KZM	Class II	2004-05-14
K030425	Lorenz Resorbable Distraction System or Expander	Biomet Microfixation	JEY	Class II	2004-05-14
K024215	Enertron CPR Jack	Enertron Engineering Co.	DRM	Class II	2004-05-14
K041131	Apple Medical Ob Mobius Elastic Retractor	CooperSurgical, Inc.	GCJ	Class II	2004-05-13
K041098	Cool Temp Natural	Coltene, Inc.	EBG	Class II	2004-05-13
K041064	Bioknotless Rc Anchor	DePuy Mitek, Inc.	JDR	Class II	2004-05-13
K040990	Modification to Self-Drilling Radiographic Markers	Biomet Microfixation	NEU	Class II	2004-05-13
K040982	Color Lcd Monitor, Model Radiforce R12	Eizo Nanao Corporation	LLZ	Class II	2004-05-13
K040811	Varelisa Ssdna Antibodies, Model 14896	Pharmacia Deutschland GmbH	LRM	Class II	2004-05-13
K040598	Kls Martin Hand Plating System	KLS-Martin L.P.	HRS	Class II	2004-05-13
K040011	Polaris 2004 Capnograph	Oridion, Ltd.	CCK	Class II	2004-05-13
K033197	Inogen Satellite Conserver	Medical Electronic Devices, Inc.	NFB	Class II	2004-05-13
K033008	Air Safety Hepa and Non-Hepa Filters	Air Safety, Ltd.	CAH	Class II	2004-05-13
K033003	Suction Coagulator	Modern Medical Equipment Mfg., Ltd.	GEI	Class II	2004-05-13
K032965	Laparoscopic Instrument, Electrode and Cable	Modern Medical Equipment Mfg., Ltd.	GEI	Class II	2004-05-13
K032818	Inogen One Oxygen Concentrator	Inogen, Inc	CAW	Class II	2004-05-13
K032322	Clear-Therm Micro Hme, Model 1441	Intersurgical Ltd.	CAH	Class II	2004-05-13