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 2026-10-12, 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 257 of 3528

510(k) clearances, page 257 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K221007	cobas HCV	Roche Molecular Systems Inc	MZP	Class II	2022-11-04
K220833	Citregen Tendon Interference Screw, Citrelock, Citrefix, Citrespline ACL, and Citrelock ACL	Acuitive Technologies	MAI	Class II	2022-11-04
K220421	BGM039 Blood Glucose Monitoring System, BGM039 Link Blood Glucose Monitoring System	Apex Biotechnology Corp.	NBW	Class II	2022-11-04
K213108	Humerus & Ulna System	Auxein medical Private Limited	HRS	Class II	2022-11-04
K212764	Medwell Technology Ltd Syringes, various sizes	Medwell Technology Limited	FMF	Class II	2022-11-04
K201256	Procise CRP, ProciseDx Analyzer, ProciseDx Calibration Cartridge	Procise Diagnostics	DCK	Class II	2022-11-04
K223355	Tera Harz Clear	Graphy Inc.	NXC	Class II	2022-11-03
K223110	truSculpt iD	Cutera Inc	GEI	Class II	2022-11-03
K222377	Led Mask Platinum Md	Cellreturn Co., Ltd.	OHS	Class II	2022-11-03
K222168	Unistik TinyTouch Sterile Single-Use Heel Incision Safety Lancets - Preemie and Full-Term, Unistik Heelstik Sterile Single-Use Heel Incision Safety Lancets - MicroPreemie, Preemie, Full-Term and Toddler	Owen Mumford Limited	FMK	Class II	2022-11-03
K222107	Black Diamond™ POCT Spinal System	Osseus Fusion Systems LLC	NKG	Class II	2022-11-03
K221719	ABTross ALIF Expandable Cage System	Aegis Spine, Inc.	MAX	Class II	2022-11-03
K221518	NP Medical nCompass Extension Set with Stabilizing Base	NP Medical	FPA	Class II	2022-11-03
K221045	Insulin Syringes without needle	Berpu Medical Technology Co., Ltd.	FMF	Class II	2022-11-03
K220466	ibiomedi Electronic Stethoscope ES-2020	Sound Land Corp.	DQD	Class II	2022-11-03
K220263	Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical Endoilluminators, Vortex Surgical Chandeliers	Vortex Surgical, Inc.	HQB	Class II	2022-11-03
K223320	Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate	Lingshi Hongruida Health Protection Technology Co., Ltd.	LZA	Class I	2022-11-02
K222395	Tango Neo, Tango Reflex Neo, Ultra Q Reflex Neo	Ellex Medical Pty Ltd	HQF	Class II	2022-11-02
K222084	OneTouch Delica Safety, HemoCue Safety Lancet, Assure Lance and Assure Lance Plus, Capiject Safety Lancet, Heel Lancet Newborn, Heel Lancet Preemie	Asahi Polyslider Co., Ltd.	FMK	Class II	2022-11-02
K221184	ORiGO System	Bien-Air Surgery SA	ERL	Class II	2022-11-02
K220371	Nitrile Two Toned Blue/Green, Powder-Free, Non-sterile, Ambidextrous, Beaded Cuff, Medical Grade Exam Gloves, Tested for Use with the Opioids Fentanyl citrate, Heroin, and both Opioids in simulated Gastric Acid (Vomit)	Summit Glove, Inc.	LZA	Class I	2022-11-02
K211816	Brightway Brand, Nitrile Examination Gloves, Powder Free (Blue) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate	Brightway Holdings Sdn. Bhd.	LZA	Class I	2022-11-02
K223270	POSE™ Health Care Surgical Mask	America'S Supply Chains	FXX	Class II	2022-11-01
K222550	Current Health System	Current Health Inc	MSX	Class II	2022-11-01
K222508	3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248	3M Company	JOJ	Class II	2022-11-01
K222258	Combined High Frequency X-ray Source	Suzhou Powersite Electric Co., Ltd.	IZL	Class II	2022-11-01
K221478	Dolphin Blue Imaging	Patterson Dental Supply, Inc.	LLZ	Class II	2022-11-01
K221247	Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Safety Needle, Sterile Disposable Needle	Jiangsu Kangbao Medical Equipment Co., Ltd	MEG	Class II	2022-11-01
K220539	Klarity SRS Baseplate, Klarity Promise Baseplate	Klarity Medical & Equipment (GZ) Co., Ltd.	IYE	Class II	2022-11-01
K214090	Back 3 COLOR	Swims America Corp	PBX	Class II	2022-11-01
K222722	Cw60n	Wide Corporation	PGY	Class II	2022-10-31
K222717	Cl24n	Wide Corporation	PGY	Class II	2022-10-31
K222318	Fresenius Liberty Select Cycler	Fresenius Medical Care Renal Therapies Group, LLC	FKX	Class II	2022-10-31
K222085	Standard Tapered Bougie, 38 Fr.	Standard Bariatrics	KNT	Class II	2022-10-31
K221810	LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation Device	Bonraybio Co., Ltd.	MQK	Class II	2022-10-31
K220929	Excelsior	MERIT CRO, Inc.	NFJ	Class II	2022-10-31
K220890	IO Needle Safety Sheath	Actuated Medical, Inc.	FMI	Class II	2022-10-31
K213697	ORiGO System	Bien-Air Surgery SA	HBC	Class II	2022-10-31
K221064	Nuheara IQbuds 2 PRO Hearing Aid	Nuheara Inc.	QUH	Class II	2022-10-30
K223098	Bakri Essential Postpartum Balloon	Cook Incorporated	OQY	Class II	2022-10-28
K223079	Stage	Spintech, Inc.	LNH	Class II	2022-10-28
K223070	Remi Robotic Navigation System	Fusion Robotics, LLC	OLO	Class II	2022-10-28
K223064	ALLY II Uterine Positioning System™ (UPS)	CooperSurgical, Inc.	LKF	Class II	2022-10-28
K223020	VS3-Iridium System (VS3-IR)	Visionsense, Ltd.	OWN	Class II	2022-10-28
K222653	JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee System	Smith+Nephew	NJD	Class II	2022-10-28
K222583	Stela Capsule System	Sdi Limited	EBF	Class II	2022-10-28
K222581	Stela Automix System	Sdi Limited	EBF	Class II	2022-10-28
K222191	Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20, SUPERSONIC MACH40	Supersonic Imagine	IYN	Class II	2022-10-28
K222031	Spinal Inner Fixation System	Changzhou Geasure Medical Apparatus and Instruments Co., Ltd	NKB	Class II	2022-10-28
K221667	Non Sterile Powder Free Latex Examination Glove	New Era Medicare Sdn Bhd	LYY	Class I	2022-10-28