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 310 of 3528

510(k) clearances, page 310 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K212468	Tigereye CTO-Crossing Catheter	Avinger, Inc.	PDU	Class II	2022-01-06
K211499	23andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related)	23AndMe, Inc.	QAZ	Class II	2022-01-06
K211135	Enlight 2100	Timpel S.A.	QEB	Class II	2022-01-06
K213951	FORZA XP Expandable Spacer System	Orthofix SRL	MAX	Class II	2022-01-05
K213879	Self-adhesive Electrode	Bozhou Rongjian Medical Appliance Co., Ltd.	GXY	Class II	2022-01-05
K213817	MPO Knee Instruments; MPO PROPHECY Knee Instruments	Microport Orthopedics Inc.	MBH	Class II	2022-01-05
K213816	MPO Hip Instruments	Microport Orthopedics Inc.	JDI	Class II	2022-01-05
K213344	Btl-899A	BTL Industries, Inc	GEI	Class II	2022-01-05
K213342	PRO-DENSE LoVisc Bone Graft Substitute	Wrightmedicaltechnologyinc	MQV	Class II	2022-01-05
K213281	PASS LP™ Spinal System, CD Horizon™ Spinal System	Medicrea International	NKB	Class II	2022-01-05
K213019	Vinyl Exam Gloves	Hebei Astro Medical Supply Co.,Ltd	LYZ	Class I	2022-01-05
K212609	BHA100 Series Braun Clear Hearing Aid	Kaz USA, Inc., A Helen of Troy Company	QDD	Class II	2022-01-05
K212115	Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic Digital Blood Pressure Monitor	Joytech Healthcare Co., Ltd.	DXN	Class II	2022-01-05
K211978	Jplant	Jj Medical Co., Ltd.	DZE	Class II	2022-01-05
K211318	PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System, PICO Fluid Management Packs	Smith Nephew Medical Limited	OMP	Class II	2022-01-05
K211149	Urethral Warming Catheter Kit	Varian Medical Systems, Inc.	GEH	Class II	2022-01-05
K213831	Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK Needle	Gyrus ACMI, Inc.	GEI	Class II	2022-01-04
K213080	T-Edge 10, T-Edge 11	Tuttnauer Ltd.	FLE	Class II	2022-01-04
K212375	Disposable Medical Surgical Mask	Jiangxi Bestgrand Health Technology Co., Ltd.	FXX	Class II	2022-01-04
K212299	Medical Surgical Mask	Wepon Medical Technology Co., Ltd.	FXX	Class II	2022-01-04
K211789	restor3d Pin Implants	restor3d, Inc.	HTY	Class II	2022-01-04
K211647	HP358EA Electrically Powered Wheelchair	Kunshan Hi-Fortune Health Products Co., Ltd.	ITI	Class II	2022-01-04
K203595	DynaFuse Fixation System	Medshape, Inc.	HWC	Class II	2022-01-04
K202994	InnoClip Disposable Clip Applier, InnoClip Clip Applier	Taiwan Surgical Corporation	FZP	Class II	2022-01-04
K213187	Disposable Nitrile Medical Powder-free Glove	Fujian Chunhui Medical Supply Co., Ltd.	LZA	Class I	2022-01-03
K213068	Medline Smoke Evacuation Shroud	MEDLINE INDUSTRIES, LP - Northfield	FYD	Class II	2022-01-03
K210830	VUZE System	Vuze Medical Ltd.	LLZ	Class II	2022-01-03
K203177	Sterisystem Dry-Base Instrument Tray	O&M Halyard, Inc.	KCT	Class II	2022-01-02
K213538	Acuity 200 with Tangible Hydra-PEG (fluoroxyfocon A) Rigid Gas Permeable Contact Lens	Acuity Polymers Inc.	HQD	Class II	2021-12-30
K212834	Disposable Nitrile Medical Examination Glove (Tested for Use with Chemotherapy Drugs)	Siyang Threeguard Medical Supplies Co., Ltd.	LZA	Class I	2021-12-30
K212547	Quick-Start Screws	Innovate Orthopaedics Ltd.	HWC	Class II	2021-12-30
K211458	Disposable Anorectal Staplers, Disposable Intraluminal Staplers, Disposable Linear Cutting Staplers, Disposable Endoscopic Cutting Staplers	Ningbo Verykind Medical Device Co., Ltd.	GDW	Class II	2021-12-30
K211263	Intrelief	Easymed Instruments Co., Ltd.	NUH	Class II	2021-12-30
K211159	eco-x Series (eco-x, eco-x-s)	HDX Will	OAS	Class II	2021-12-30
K202898	Tzoar 207 Negative Pressure Wound Therapy (NPWT) System	Lightstone Medical Products (Ningbo) Co Ltd	OMP	Class II	2021-12-30
K213776	LiverSmart	Resonance Health Analysis Services Pty Ltd	PCS	Class II	2021-12-29
K213316	Life Scope PT BSM-1700 Series, AY Series, Data Acquisition Unit, LIFE SCOPE BSM 6000 SERIES BEDSIDE MONITORING SYSTEM, Nihon Kohden CSM-1901 BEDSIDE MONITORING SYSTEM	Nihon Kohden Corp.	KOI	Class II	2021-12-29
K213073	Goody Gloves, Wincare, TBG Gloves	Thai Rubber Gloves Company Limited	LYY	Class I	2021-12-29
K212656	Flexible Intubation Video Endoscope – Sterile (FIVE-S)	Karl Storz Endoscopy-America, Inc.	EOQ	Class II	2021-12-29
K211156	CONVIVO In Vivo Pathology Suite	Carl Zeiss Meditec Inc	LLZ	Class II	2021-12-29
K202101	GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+), GEM Hemochron 100 Low Range Activated Clotting Time Test (ACT-LR), directCHECK ACT+ Whole Blood Control, Level 1 and Level 2, directCHECK ACT-LR Whole Blood Control, Level 1 and Level 2	Accriva Diagnostics, Inc.	JPA	Class II	2021-12-29
K213209	EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device	K1 Medical, LLC	KCT	Class II	2021-12-28
K213016	ATM Glove	Phu Duc Huy Production Trading Services Corporation	LZA	Class I	2021-12-28
K212806	Alcon (serafilcon A) soft contact lenses for daily wear	Alcon Laboratories	LPL	Class II	2021-12-28
K213763	Sonosite PX Ultrasound System	FUJIFILM SonoSite,Inc.	IYN	Class II	2021-12-27
K212848	Sterile Latex Surgical Gloves Powder Free	Pentavest Holdings Sdn Bhd	KGO	Class I	2021-12-27
K212716	Dermoaroma Disposable Nitrile Examination Glove	Chuzhou Harmony Gloves Medical Technology Co.,Ltd	LZA	Class I	2021-12-27
K193138	Colibri System	Copan WASP	QQV	Class II	2021-12-27
K211770	R3ACT Stabilization System	Paragon 28	HWC	Class II	2021-12-25
K203523	Fixone hybrid knotless anchor	Aju Medical Co., Ltd.	MAI	Class II	2021-12-25