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 2026-11-02, 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 1053 of 3531

510(k) clearances, page 1053 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K090055	Low & High Speed Kit	DPM USA Corp.	EFA	Class I	2009-10-27
K093058	Tsrh Spinal System	Medtronic Sofamor Danek	NKB	Class II	2009-10-26
K092544	Instrumed Vascular Clamps	Instrumed International Inc dba Avalign German Specialty Instruments	DXC	Class II	2009-10-26
K091696	Savi Wireless, Model Pm500	Medicomp, Inc.	DRG	Class II	2009-10-26
K091413	S-Test Cholesterol (Cho), Model Rc0009, S-Test Hdl Cholesterol (Hdl), Model Rc0015, S-Test Triglycerides (Tg)	Alfa Wassermann	CHH	Class I	2009-10-26
K091000	Kneekg	Emovi	LXJ	Class II	2009-10-26
K083077	Ulc Spinal Pedicle Screw System	Otis Biotech Co., Ltd.	MNH	Class II	2009-10-26
K093183	Bis Quatro Sensor	Aspect Medical Systems, Inc.	GXY	Class II	2009-10-23
K092990	Amd 6605 Tens/nmes	Advantageous Medical Devices, LLC	GZJ	Class II	2009-10-23
K092961	Jazzy Frontie	Pride Mobility Products Corp	ITI	Class II	2009-10-23
K092919	Microscan Synergies Plus Mic/combo Panels, Model B1025	Siemens Healthcare Diagnostics Inc.	LON	Class II	2009-10-23
K092456	Microlife Wrist Watch Blood Pressure Monitor, Model Bp3bs1-3C	Microlife Intellectual Property GmbH	DXN	Class II	2009-10-23
K092443	Interface Acetabular Cup Liners	Omni Life Science, Inc.	LPH	Class II	2009-10-23
K092418	Entracare Gastrostomy Feeding Tube	Entracare Corp.	KNT	Class II	2009-10-23
K091935	Lipiview Ocular Surface Interferometer	TearScience, Inc.	HKI	Class II	2009-10-23
K091871	Dk50 Ds	Ekom s.r.o.	BTI	Class II	2009-10-23
K091606	Vertaplex Hv (Single Pack and Dual Pack)	Stryker Corp.	NDN	Class II	2009-10-23
K091305	Clearpath	Easyglide, Ltd.	FDF	Class II	2009-10-23
K091240	Alphamed Surgical Spear, Model 70-5000	Alphamed, Inc.	HOZ	Class II	2009-10-23
K091191	Gas Transfill	Respironics Inc., Sleep & Home Respiratory Group	CAW	Class II	2009-10-23
K091102	Assure Platinum and Glucocard Vital Blood Glucose Monitoring Systems	Arkray Factory USA, Inc.	CGA	Class II	2009-10-23
K091100	Myosure Hysteroscopic Tissue Removal System	Interlace Medical, Inc.	HIH	Class II	2009-10-23
K090897	Tritanium Non-Modular Shell & X3 All-Poly Insert	Howmedica Osteonics Corp	LPH	Class II	2009-10-23
K090751	Comet Anterior Cervical Plate System	Apollo Spine, Inc.	KWQ	Class II	2009-10-23
K090641	Curios	Progentix Orthobiology BV	MQV	Class II	2009-10-23
K090542	Sun-Rain Ultrasonic Therapy Models, Su-300, Su-400, Su-500, Su-600, Su-700, Su-800, Su-900	Sun-Rain System Corp.	IMI	Class II	2009-10-23
K082207	Orthocad Iq	Cadent, Inc.	DYW	Class II	2009-10-23
K092783	Debp	Enko, Ltd.	HGX	Class II	2009-10-22
K092630	Zirox	Zencera, Inc.	EIH	Class II	2009-10-22
K092301	Powder Free Vinyl Patient Examination Gloves, (Yellow, White, Blue, Pink)	Bettercare Plastic Products Co., Ltd.	LYZ	Class I	2009-10-22
K092010	Pc ECG, Model Se-1010	Edan Instruments, Inc.	DPS	Class II	2009-10-22
K091499	Medeor Matrix, Models 30010-Xx (Hydrated); 30020-Xx (Dry)	DSM Biomedical, Inc.	FTM	Class II	2009-10-22
K091389	Equalshield Luer Lock Connector Pair	Plastmed, Ltd.	LHI	Class II	2009-10-22
K090823	Theraform Bilayer	Sewon Cellontech Co., Ltd.	KGN	Unclassified	2009-10-22
K093116	Modification to: Ramp Influenza A/b Assay	Response Biomedical Corp.	PSZ	Class II	2009-10-21
K092957	Verigene System, Verigene Respiratory Virus Nucleic Acid Test	Luminex Corporation	OCC	Class II	2009-10-21
K092887	Easyplus Mini Masterdriver Self Monitoring Blood Glucose System, Model Eps09009	Eps Bio Technology Corp.	NBW	Class II	2009-10-21
K092882	D3 Fastpoint L-Dfa Influenza A/influenza B Virus Identification Kit	Ortho-Clinical Diagnostics, Inc.	GNW	Class I	2009-10-21
K092824	N95 Respirator Mask, Positive Facial Lock with Magic Arch, Model 695	Alpha Protech, Inc.	MSH	Class II	2009-10-21
K092616	Ascent Bond Universal Adhesive System, Models 006-00029, 006-00030, 006-00044, 006-00045	Cao Group, Inc.	KLE	Class II	2009-10-21
K092604	Large Face Aneroid Sphygmomanometer, Wall Model, Desk Model, Mobile Stand Model, Model 41Xx, 42Xx, 43Xx	Trimline Medical Products Corp.	DXQ	Class II	2009-10-21
K092492	Powder Free Polymer Coated Latex Examination Gloves, Non-Sterile, with Protein Labeling Claim of 50 Micrograms per Dm2 O	Wear Safe (Malaysia) Sdn Bhd	LYY	Class I	2009-10-21
K092425	Reprocessed 3D Diagnostic Ultrasound Catheters, Model Sndstr10	Stryker Sustainability Solutions	OWQ	Class II	2009-10-21
K092411	Pearlescent Powder Free Nitrile Examination Gloves with Aloe Vera (Yellow, Red, Green, Black, Blue)	Shen Wei (USA), Inc.	LZA	Class I	2009-10-21
K092296	Powder Free Examination Glove	Bettercare Plastic Products Co., Ltd.	LYZ	Class I	2009-10-21
K092294	Vinyl Co-Polmer Free Examination Gloves, Blue Color	Bettercare Plastic Products Co., Ltd.	LYZ	Class I	2009-10-21
K092283	Dimension Vista Immunoglobulin Igg Subclasss 1Flex Reagent Cartridge, Dimension Vista Immunoglobulin Igg	Siemens Healthcare Diagnostics Inc.	DFZ	Class II	2009-10-21
K092101	Reusable Pulse Oximeter Sensor, Model 8000 Series	Nonin Medical, Inc	DQA	Class II	2009-10-21
K091414	Vtrust Blood Pressure Monitor, Model Vtrust 701Dh	Biocare Corp.	DXN	Class II	2009-10-21
K091354	Acryderm Silver Antimicrobial Foam Wound Dressing	Acrymed, Inc.	FRO	Unclassified	2009-10-21