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 370 of 3528

510(k) clearances, page 370 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K193079	ICE COMPRESSION FIRST, DUO, & MOOVE Systems	Mks Paris	IRP	Class II	2021-01-11
K202874	Puritan Bennett Cuff Pressure Manager	Medtronic, Inc.	BSK	Class II	2021-01-09
K200717	CLEWICU System (ClewICUServer and ClewICUnitor)	Clew Medical, Ltd.	QNL	Class II	2021-01-09
K203630	BioGuard Air/Water and Suction Valves	Steris Corporations	ODC	Class II	2021-01-08
K203341	ACS LD Uni FB Knee System	implantcast GmbH	HSX	Class II	2021-01-08
K203329	HeartFlow Analysis	Heartflow, Inc.	PJA	Class II	2021-01-08
K203114	Logiq P10, Logiq P9, Logiq P8	GE Healthcare	IYN	Class II	2021-01-08
K202721	Celerity 20 Steam Biological Indicator for IUSS	STERIS Corporation	FRC	Class II	2021-01-08
K202291	Button Loop	Yunyi (Beijing) Medical Device Co., Ltd.	MBI	Class II	2021-01-08
K202278	OBS Anchorage Screw, Biokey Anchorage Screw	Bomei Co., Ltd.	OAT	Class II	2021-01-08
K202017	Passion Natural Water Based Lubricant	Xr, LLC	NUC	Class II	2021-01-08
K201778	i-STAT TBI Plasma cartridge with the i-STAT Alinity System	Abbott Medical	QAT	Class II	2021-01-08
K201259	ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating System	Wrightmedicaltechnologyinc	HRS	Class II	2021-01-08
K203345	MULTIX Impact	Siemens Medical Solutions USA, Inc.	KPR	Class II	2021-01-07
K203117	TissueTak device	Via Surgical, Ltd.	GDW	Class II	2021-01-07
K202622	Halyard Lavender, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and and Fentanyl Citrate	O&M Halyard, Inc.	LZA	Class I	2021-01-07
K202544	Instylla Delivery Kit	Instylla, Inc.	FMF	Class II	2021-01-07
K202488	ZSFab Cervical Interbody System	Zsfab, Inc.	ODP	Class II	2021-01-07
K202414	BrainInsight	Hyperfine Research, Inc.	LLZ	Class II	2021-01-07
K202405	BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19, BeneVision N22, BeneVision N1	Shenzhen Mindray Bio-Medical Electronics Co.,LTD	MHX	Class II	2021-01-07
K201577	MatriDerm	MedSkin Solutions Dr. Suwelack AG	KGN	Unclassified	2021-01-07
K200918	SurgiWrap FROST	Mast Biosurgery	FTL	Class II	2021-01-07
K203652	Blood Pressure Cuff, U1883S,U1883D, U1882S, U1882D, U1881S, U1881D, Blood Pressure Cuff, U1885S, U1885D, U1880S, U1880D, U1886S, U1886D, Blood Pressure Cuff, U1869S, U1869D, U1889S, U1889D, U1884S, U1884D, Blood Pressure Cuff, U1710S, U1720S, U1730S,U1740S, U1750S, U1760S, Blood Pressure Cuff, U1770S, U1790s, U1710D, U1720D, U1730D, U1740D	JKH USA, LLC	DXQ	Class II	2021-01-06
K203465	OSSIOfiber Cannulated Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, Cannulated Design	OSSIO, Ltd.	HTY	Class II	2021-01-06
K203340	MULTIX Impact C	Siemens Medical Solutions USA, Inc.	KPR	Class II	2021-01-06
K203339	NEOLab Clear Aligners	New England Ortho Lab, Inc.	NXC	Class II	2021-01-06
K202844	Medical Surgical Gowns	Beijing Biosis Healing Biolog Ical Technology Co., Ltd.	FYA	Class II	2021-01-06
K202810	AutoStrut G2	Orthospin	KTT	Class II	2021-01-06
K202594	Medical Surgical Masks-Non Sterile	Shandong T&F Nonwoven Co., Ltd.	FXX	Class II	2021-01-06
K202495	SIRION Lateral Lumbar Interbody Fusion	Astura Medical	MAX	Class II	2021-01-06
K202491	Disposable Surgical Face Mask	Jiangsu Newvalue Medical Products Co., Ltd.	FXX	Class II	2021-01-06
K202350	SR-1000 Portable DR Imaging System, SR-1000S Portable DR Imaging System	Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)	IZL	Class II	2021-01-06
K200999	Thermidas IR System (ThIR-A615)	Thermidas Americas, Inc.	LHQ	Class I	2021-01-06
K200769	Disposable Endoscope Valves Set, Disposable Endoscope Valves Set B	Wilson Instruments (Sha) Co., Ltd.	ODC	Class II	2021-01-06
K200560	InBody	InBody Co, Ltd.	DXN	Class II	2021-01-06
K200382	Btl-703-2	Btl	NGX	Class II	2021-01-06
K200021	Applied Medical Anoscope	Applied Medical Resources Corp	FER	Class II	2021-01-06
K202857	ClearPath Aligner	Clearpath Orthodontics	NXC	Class II	2021-01-05
K202791	iHealth Clinical Digital Thermometer	Andon Health Co., Ltd	FLL	Class II	2021-01-05
K201872	NeutrArt	Asset Medikal Tasarim AS.	FPA	Class II	2021-01-05
K201114	Bidop 7	Koven Technology, Inc.	DPW	Class II	2021-01-05
K200963	Halo Single-Loop Microsnare Kit	Argon Medical Devices, Inc	MMX	Class II	2021-01-05
K200491	Bfix Orthopedic External Fixator Systems	Aike (Shanghai) Medical Instrument Co., Ltd.	KTT	Class II	2021-01-05
K200298	ABI Instrument, Creo Electrosurgical System	Creo Medical Ltd	NEY	Class II	2021-01-05
K200159	Non-contact Infrared Body Thermometer, model:HTD8823US	Hetaida Technology Co., Ltd.	FLL	Class II	2021-01-05
K193497	Fixone Biocomposite Interference Screw	Aju Medical Co., Ltd.	HWC	Class II	2021-01-05
K193273	Insulin Syringe	Promisemed Hangzhou Meditech Co.,Ltd.	FMF	Class II	2021-01-05
K203561	ChoiceSpine Navigation System	Choice Spine LLC	OLO	Class II	2021-01-04
K202880	J-Plasma Precise FLEX Handpiece	Apyx Medical Corporation (Formerly Bovie Medical Corporation	GEI	Class II	2021-01-04
K202719	Disposable Medical Face Masks	Jiangxi Sanxin Medtec Co.,Ltd.	FXX	Class II	2021-01-04