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 327 of 3528

510(k) clearances, page 327 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K211740	DualX	Amplify Surgical	MAX	Class II	2021-09-29
K210763	Inman Digital Clear Aligners	Inman Orthodontic Laboratories, Inc.	NXC	Class II	2021-09-29
K210726	ImmersiveTouch	ImmersiveTouch, Inc.	LLZ	Class II	2021-09-29
K210590	Axis Spine Technologies ALIF	Axis Spine Technologies Ltd	OVD	Class II	2021-09-29
K210513	UNIWEB Surgical Mask, Model: ASTM Level 1, UNIWEB Surgical Mask, Model: ASTM Level 2	Universal Incorporation	FXX	Class II	2021-09-29
K203668	RELI NRFit Epidural Needles, Phoenix NRFit Epidural Needles, RELI NRFit Spinal Needles, Phoenix NRFit Spinal Needles	Myco Medical Supplies Inc	BSP	Class II	2021-09-29
K203350	ENDOtube	Nissha Medical Technologies SAS	OCX	Class II	2021-09-29
K200639	LAP-iX	Sejong Medical Co., Ltd.	GEI	Class II	2021-09-29
K212320	Dermatac™ Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology-Small (5 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology -Small (10 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology - Medium(5 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology -Medium (10 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology- Large (5 pac	3M Healthcare Business Group	OMP	Class II	2021-09-28
K212129	Persona® Personalized Knee System	Zimmer Switzerland Manufacturing GmbH	JWH	Class II	2021-09-28
K212045	SoftSpot	Pediametrix Inc	QQO	Class I	2021-09-28
K211964	SubtlePET	Subtle Medical Inc	KPS	Class II	2021-09-28
K211794	Disposable surgical mask	Shanghai No.9 Knitting Mill Co., Ltd.	FXX	Class II	2021-09-28
K211760	Panther OIS	Prowess, Inc.	IYE	Class II	2021-09-28
K211700	EzDent Web	Ewoosoft Co., Ltd	LLZ	Class II	2021-09-28
K210894	Siddharth-II; Impact	Panacea Medical Technologies Pvt., Ltd.	IYE	Class II	2021-09-28
K210878	Surgical Face Mask (Model: CM2006, CM2008, A88)	Shenzhen Realtone Medical Appliance Co., Ltd.	FXX	Class II	2021-09-28
K210561	Advisor Pro Platform	Dreamed Diabetes Ltd	QCC	Class II	2021-09-28
K202481	ThermArt (Model IR-EFT)	Comper Chuangxiang (Beijing) Technology Co., Ltd.	FLL	Class II	2021-09-28
K201855	Electrically Powered Wheelchair -Model HP358E	Kunshan Hi-Fortune Health Products Co., Ltd.	ITI	Class II	2021-09-28
K212750	Ultrasonic Surgical Aspirator System, Model: XD880B	Smtp Technology Co., Ltd.	LFL	Unclassified	2021-09-27
K212738	Amplatzer Talisman Delivery Sheath	Abbott Medical	DQY	Class II	2021-09-27
K212643	POWERSEAL Curved Jaw Sealer and Divider, Double Action	Olympus Surgical Technologies America	GEI	Class II	2021-09-27
K212080	Imaging Plate Scanner, i-Scan	Guilin Woodpecker Medical Instrument Co., Ltd	MUH	Class II	2021-09-27
K212028	Dark Star Navigation Instrument System	Republic Spine	OLO	Class II	2021-09-27
K212026	Amplatzer Steerable Delivery Sheath	Abbott Medical	DQY	Class II	2021-09-27
K211236	Disposable Vinyl Examination Gloves	Tangshan Hongyun Healthcare Products Co., Ltd.	LYZ	Class I	2021-09-27
K203674	B Dispensing Line	Aea SRL	LHI	Class II	2021-09-27
K212328	DiscCath Needle Set	Disccath, LLC	BSP	Class II	2021-09-26
K210908	Surgical Mask	Sichuan Prius Biotechnology Co., Ltd.	FXX	Class II	2021-09-26
K203731	DT100 Digital Thermometer	Smart Technology Co., Ltd.	FLL	Class II	2021-09-26
K202459	Bact-Trap Filter, Bact-Trap Mini, Bact-Trap Midi, Pharma Mini HME/Filter, Bact-HME HME/Filter and Bact-HME Midi HME/Filter	Pharma System AB	CAH	Class II	2021-09-26
K201592	Cardinal Health Protexis PI Blue with Neu-Thera Surgical Glove	Cardinal Health200, LLC	KGO	Class I	2021-09-26
K212777	Collaboration Live	Philips North America LLC	LLZ	Class II	2021-09-24
K212725	ViperCross Support Catheters	Cardiovascular Systems Incorporated	DQY	Class II	2021-09-24
K212704	Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound System	Philips North America LLC	IYN	Class II	2021-09-24
K212557	Virtual C DRF-NEO Digital Imaging System	Portavision Medical, LLC	OWB	Class II	2021-09-24
K212125	Nobel Biocare Dental Implant Systems Portfolio - MR Conditional	Nobel Biocare AB	DZE	Class II	2021-09-24
K212108	Dynamic TiBase	Talladium Espana, SL	NHA	Class II	2021-09-24
K212099	Red Wave Hair Removal	Shenzhen Accompany Technology Co., Ltd.	ONF	Class II	2021-09-24
K211973	DRI Cocaine Metabolite Assay	Microgenics Corporation	DIO	Class II	2021-09-24
K211505	Encore Hip Stem	Signature Orthopaedics Pty Limited	MEH	Class II	2021-09-24
K210857	Personal Lubricant	Shenzhen Huanqiu Xuebao Technology Co., Ltd.	NUC	Class II	2021-09-24
K202618	IV Administration Sets	B.Braun Medical, Inc.	FPA	Class II	2021-09-24
K212792	Medynus IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage	Medynus, Inc.	ODP	Class II	2021-09-23
K212728	Standard Bougie, 38 Fr. and Hand Pump	Standard Bariatrics	KNT	Class II	2021-09-23
K212708	Halo One Thin-Walled Guiding Sheath	C.R. Bard Inc	DYB	Class II	2021-09-23
K212411	Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS)	ConforMIS, Inc.	JWH	Class II	2021-09-23
K212342	ZIIP+ Device	Ziip, Inc.	NFO	Class II	2021-09-23
K212321	JiveX (Model Number / Release: 5.3)	Visus Health IT GmbH	LLZ	Class II	2021-09-23