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 1494 of 3531

510(k) clearances, page 1494 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K023810	Modification to Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery	Bioplate Inc	JEY	Class II	2002-12-04
K023718	Quickset Mimix Bone Void Filler	Biomet Microfixation	GXP	Class II	2002-12-04
K023700	Pvs 1600 Synchro 0.010 Neuro Guide Wire	Precision Vascular Systems, Inc.	DQX	Class II	2002-12-04
K023574	Gizmo	Freedom Designs Inc	IOR	Class I	2002-12-04
K023251	Pediatric Arterial Cannula	Polystan A/S	DWF	Class II	2002-12-04
K023242	I-Plant Model 3500 (125Iodine Brachytherapy Seeds)-Sterile	Implant Sciences Corp.	KXK	Class II	2002-12-04
K023016	Nicore Model Ncp-1 External Counterpulsation Device	Nicore Equipment & Leasing, Inc.	DRN	Class II	2002-12-04
K022963	Transonic Syringe Warmer, Model Syr-1000	Transonic Systems Inc	MQS	Class II	2002-12-04
K022048	Interpore Cross International (Ici) Occipito-Cervico-Thoracic (Oct) Rod and Plate System	Interpore Cross Intl.	KWP	Class II	2002-12-04
K021489	Repiphysis Limb Salvage System	Wrightmedicaltechnologyinc	KRO	Class II	2002-12-04
K023798	Modification to Envoy Patient Monitor	Mennen Medical, Inc.	DSI	Class II	2002-12-03
K023380	T-Wave Altermans (Twa) Algorithm Option	General Electric Medical Systems Information Techn	DQK	Class II	2002-12-03
K023108	Steripack Sterile Disposable Syringe & Sterile Disposable Insulin Syringe	Atlantic Products, Inc.	FMF	Class II	2002-12-03
K023067	Imtec Sendax Mdi Ortho6 and Ortho8	Imtec Corp.	DZE	Class II	2002-12-03
K022176	Orion Diagnostica Ultrasensitive Crp Kit, Model 68025, & Orion Diagnostica Ultrasensitive Crp Control, Model 68257	Orion Diagnostica, Div. Orion Corp.	DCK	Class II	2002-12-03
K021098	Daum-Lectric MRI Drilling Machine	Mri Devices Daum GmbH	ERL	Class II	2002-12-03
K020440	Newcor	Siemens Medical Solutions USA, Inc.	DQK	Class II	2002-12-03
K023581	Comfort Agile Scooter, Ly-Ew303	Comfort Orthopedic Co., Ltd.	INI	Class II	2002-12-02
K023543	Evlt Kit and D15plus and D30plus Diode	Diomed, Inc.	GEX	Class II	2002-12-02
K023517	Dermagrip-P Powder Free Pink Nitrile Examination Gloves, Non-Sterile	WRP Asia Pacific Sdn Bhd	LZA	Class I	2002-12-02
K023514	Trellis-6 Peripheral Infusion System (140Cm Catheter Length 10Cm Infusion Length)	Bacchus Vascular, Inc.	QEY	Class II	2002-12-02
K023485	Explorer Powered Wheelchair	Evermed, Inc.	ITI	Class II	2002-12-02
K023327	Cynovad Zirkon	Cynovad	EIH	Class II	2002-12-02
K023187	Ksea Spinoscope	Karl Storz Endoscopy-America, Inc.	HRX	Class II	2002-12-02
K023046	Sst Saliva Supporting Tablets	Sinclair Pharmaceuticals Ltd	LED	Class I	2002-12-02
K023035	Sr Vivotac/sr Orthotac, Modifier Monomer & Polymer	Ivoclar Vivadent, Inc.	ELM	Class II	2002-12-02
K022995	Collatek Hydrogel	Biocore Medical Technologies, Inc.	MGQ	Unclassified	2002-12-02
K022993	Hoveround Rehab Seating System for Power Wheelchairs	Hoveround Corp.	ITI	Class II	2002-12-02
K022952	Modular Head Bone Screw	Zimmer GmbH	HWC	Class II	2002-12-02
K022933	Evenflo Comfort Select Auto-Cycle Breast Pump Kit	Evenflo Company, Inc.	HGX	Class II	2002-12-02
K022911	Model Ami1200 C-Arm	Integrity Practice Management, Inc.	JAA	Class II	2002-12-02
K022698	Scooter Mars Series, Model Tl-588	Teh Lin Prosthetic & Orthopaedic, Inc.	INI	Class II	2002-12-02
K022640	Solera Magnum Thrombectomy Catheter, 55 Cm, Model Bac Smg 007 055 & Solera Magnum Thrombectomy Catheter, 110 Cm	Bacchus Vascular, Inc.	MCW	Class II	2002-12-02
K022518	J.p. 3-Wheeled Scooter, Es-350 Citybug II/ Rabbit	Roc Chinese-European Industrial Research Society	INI	Class II	2002-12-02
K022494	Home Care Jelly	Roc Chinese-European Industrial Research Society	GYB	Class II	2002-12-02
K021859	Wrist Implant	Avanta Orthopaedics, Inc.	JWJ	Class II	2002-12-02
K021501	V.a.c. Instillamat (Vacuum Assisted Closure Instillamat	KCI USA, Inc.	OMP	Class II	2002-12-02
K021430	Sanidad TENS-Duo Mode Gp8016n	Rolor Electronics Corp.	GZJ	Class II	2002-12-02
K020837	Motex Latex Examination Gloves, Powder-Free	Shanghai Motex Healthcare Co., Ltd.	LYY	Class I	2002-12-02
K020533	Exel Vaculet Blood Collection Set	Exelint Intl. Co.	FPA	Class II	2002-12-02
K020130	Rolor Powered Muscle Stimulator, Model Gp-8016M	Rolor Electronics Corp.	IPF	Class II	2002-12-02
K023812	Nessy (Omega) Disposable Split Return Electrodes, Models P/n: 20193-084 and P/n: 20193-085	Erbe USA Inc	GEI	Class II	2002-11-29
K023767	Ues-30 Electrosurgical Unit and It's Associated Accessories	Olympus Optical Co., Ltd.	GEI	Class II	2002-11-29
K023765	Stellartech Coagulation System (Models 1100C-115 & 1100C-230)	Stellartech Research Corp.	GEI	Class II	2002-11-29
K023674	Philips Drug Calculator Software	Philips North America LLC	MHX	Class II	2002-11-29
K023524	Ever-More Powder-Free Latex Examination Gloves	Ever-More Latex Products Sdn Bhd	LYY	Class I	2002-11-29
K023523	Ever-More Powder-Free Polymer-Coated Latex Examination Gloves	Ever-More Latex Products Sdn Bhd	LYY	Class I	2002-11-29
K023522	Ever-More Powder-Free Latex Examination Gloves, Blue Color	Ever-More Latex Products Sdn Bhd	LYY	Class I	2002-11-29
K022915	Instant-View Propoxyphene (Ppx) Urine Test	Alfa Scientific Designs, Inc.	JXN	Class II	2002-11-29
K020883	Elecsys Probnp Calcheck	Roche Diagnostics GmbH	JJX	Class I	2002-11-29