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 2026-10-15, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,969 of the 176,366 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	2,569

176,366 records, page 414 of 3528

510(k) clearances, page 414 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K191422	Neural Navigator	Soterix Medical,Inc.	HAW	Class II	2020-04-06
K200638	LAP-iX Suction Irrigation	Sejong Medical Co., Ltd.	HET	Class II	2020-04-03
K200608	Eclipse Treatment Planning System v16.0	Varian Medical Systems, Inc.	MUJ	Class II	2020-04-03
K200577	RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP/7053HP Single Chamber Washer/Disinfector	STERIS Corporation	NVE	Class II	2020-04-03
K200566	ADAPT Tissue	Admedus Regen Pty, Ltd.	PSQ	Class II	2020-04-03
K200564	Aria System	Inova Labs, Inc.	JOW	Class II	2020-04-03
K200022	FLUSION-9001, Fluoroscopic C-arm Mobile X-ray System	Livermoretech,Inc	OWB	Class II	2020-04-03
K193026	Visera Elite II Video System Center, Visera Elite II Endoeye 3D	Olympus Medical Systems Corp.	GCJ	Class II	2020-04-03
K192735	Diode Laser Hair Removal Machine	Beijing Lead Beauty S & T Co., Ltd.	GEX	Class II	2020-04-03
K192719	Osom Ultra Plus Flu A&B Test Kit	Sekisui Diagnostics, LLC	PSZ	Class II	2020-04-03
K192015	Faico Dental Implant System	Faico Medical, LLC	DZE	Class II	2020-04-03
K200696	FIREBIRD SI Fusion System	Orthofix SRL	OUR	Class II	2020-04-02
K200552	EVOS Lumbar Interbody System	Cutting Edge Spine	MAX	Class II	2020-04-02
K200319	HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface Cable	DeRoyal Industries, Inc.	FMT	Class II	2020-04-02
K200251	Z5/Z50/Z50T/Z50S/Z50 Pro Diagnostic Ultrasound System	Shenzhen Mindray Bio-Medical Electronics Co.,LTD	IYN	Class II	2020-04-02
K200010	FilmArray BCID2 Control Panel M416	Maine Molecular Quality Controls, Inc.	PMN	Class II	2020-04-02
K193591	Arc 400	Bowa-Electronics GmbH & Co. KG	GEI	Class II	2020-04-02
K193390	CS Model+	Trophy	PNN	Class II	2020-04-02
K193322	NovaCross CTO Microcatheter	Nitiloop, Ltd.	DQY	Class II	2020-04-02
K193095	Ambu aScope 4 Cysto	Ambu A/S	FAJ	Class II	2020-04-02
K193027	Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal Stethoscope 18 French, Esophageal Stethoscope, 24 French	DeRoyal Industries, Inc.	BZT	Class II	2020-04-02
K192958	TwitchView System	Blink Device Company	KOI	Class II	2020-04-02
K192646	SYMPHONY™ OCT System	Medos International SARL	NKG	Class II	2020-04-02
K192514	Patient Monitor	Edan Instruments, Inc.	MHX	Class II	2020-04-02
K192445	QwikCheck Chemical Indicators	Serim Research Corp.	JOJ	Class II	2020-04-02
K192176	IntelePACS	Intelerad Medical Systems Incorporated	LLZ	Class II	2020-04-02
K192101	Medone Ultra, Medextra	Medax S.r.l. Unipersonale	KNW	Class II	2020-04-02
K192099	MED-I Bone Marrow Aspiration Needle, MED-S Bone Marrow Aspiration Needle, MED-L Bone Marrow Biopsy and Aspiration System, MED-B Bone Marrow Biopsy System, MED-J Bone Marrow Biopsy and Aspiration System	Medax S.r.l. Unipersonale	KNW	Class II	2020-04-02
K192006	SIRION Lateral Lumbar Interbody System	Astura Medical	MAX	Class II	2020-04-02
K200622	Focus 43C detector, TRIMAX 43C detector	Iray Technology Taicang, Ltd.	MQB	Class II	2020-04-01
K200524	SOMATOM X.cite, Scan&GO, SOMATOM go.Platform - go.Up, go.Now, go.Top, go.All, go. Sim, go. Open Pro, Scan&GO	Siemens Medical Solutions USA, Inc.	JAK	Class II	2020-04-01
K200188	DSI Dental Implant System	Dsi Dental Solutions Ltd	DZE	Class II	2020-04-01
K200119	LOGIQ E10s	GE Healthcare	IYN	Class II	2020-04-01
K193580	VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Right, VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Left, VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Right, VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Left	Orthosensor, Inc.	ONN	Class II	2020-04-01
K192988	Dermasure Green Sterile SyntheticPolychloroprene Powder-Free Surgical Glove Tested for Use	MEDLINE INDUSTRIES, LP - Northfield	KGO	Class I	2020-04-01
K192676	Introcan Safety 2 IV Catheter 18-24 gauge	B.Braun Medical, Inc.	FOZ	Class II	2020-04-01
K192658	Manual Wheelchair	Jerry Medical Instrument (Shanghai) Co., Ltd.	IOR	Class I	2020-04-01
K192228	CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical TD-12 high-level disinfectant	CS Medical LLC	PSW	Class II	2020-04-01
K191762	Magnetic Surgical System	Levita Magnetics International Corp.	PNL	Class II	2020-04-01
K191065	Venus VivaTM	Venus Concept USA Inc.	GEI	Class II	2020-04-01
K200741	Tablo Hemodialysis System	Outset Medical, Inc.	KDI	Class II	2020-03-31
K200556	AquaFlate Pre-Filled Sterile Water Syringe 10mL	H R Pharmaceuticals, Inc.	EZL	Class II	2020-03-31
K200455	Trigger Switch and Cord	New Deantronics Taiwan Ltd.	GEI	Class II	2020-03-31
K200281	The Gecko Spinal System	Ortho Development Corp.	OWI	Class II	2020-03-31
K200278	CytoCore	Praxis Medical LLC	KNW	Class II	2020-03-31
K193524	SI-BONE iFuse Implant System®	SI-Bone, Inc.	OUR	Class II	2020-03-31
K193087	Rapid ICH	Ischemaview Incorporated	QAS	Class II	2020-03-31
K193054	Sectra Digital Pathology Module	Sectra AB	QKQ	Class II	2020-03-31
K192818	Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal System	Stryker Corp.	PML	Class II	2020-03-31
K192413	SiteSeal Femoral Compression Device	Ensite Vacular, LLC	DXC	Class II	2020-03-31