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 315 of 3528

510(k) clearances, page 315 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K212435	Comprehensive Humeral Fracture Positioning Sleeves	Zimmer GmbH	KWS	Class II	2021-12-10
K212349	Powder Free, White, Blue, Pink, Black Nitrile Synthetic Rubber Examination Gloves	Medi Legion Sdn.Bhd	LZA	Class I	2021-12-10
K212176	CINtec Histology	Ventana Medical Systems Inc	PRB	Class II	2021-12-10
K212137	X-Clever	LG Electronics.Inc	LLZ	Class II	2021-12-10
K211997	8 mm SureForm 30 Curved-Tip Stapler, 8 mm SureForm 30 Stapler, SureForm 30 Reloads	Intuitive Surgical, Inc.	NAY	Class II	2021-12-10
K211612	Medline UNITE REFLEX Dynamic Discs	MEDLINE INDUSTRIES, LP - Northfield	HTN	Class II	2021-12-10
K211560	Airvo Nebulizer Adapter	Fisher & Paykel Healthcare, Inc.	CAF	Class II	2021-12-10
K210847	UltraClear Fractional Laser System	Fa International, LP	GEX	Class II	2021-12-10
K210842	VerSys Cemented Revision/Calcar	Zimmer GmbH	JDI	Class II	2021-12-10
K210004	i8 Tanning Booth	Ultrasun International B.V.	FTC	Class II	2021-12-10
K203743	Exa	Konica Minolta, Inc.	LLZ	Class II	2021-12-10
K203723	Branchor Balloon Guide Catheter	Asahi Intecc Co., Ltd.	QJP	Class II	2021-12-10
K203615	Dental Scaler and Air Polisher	Guilin Woodpecker Medical Instrument Co., Ltd	ELC	Class II	2021-12-10
K203539	Unico Global level 3 Surgical Gown (Film-reinforced SMS), Unico Global Level 3 Surgical Gown (PP+PE)	Unicoglobal, Inc.	FYA	Class II	2021-12-10
K202510	AMG PMP Infant	Eurosets S.r.l.	DTZ	Class II	2021-12-10
K201600	Infrared thermometer, models KFT-22M, KFT-22, KFT-23, KFT-24, KFT-25, KFT-26, KFT-27, KFT-28	Kangfu Medical Equipment Factory	FLL	Class II	2021-12-10
DEN200041	Comfort Marker 2.0.	Medical Precision BV	QRN	Class II	2021-12-10
K213530	Nextra CH Cannulated Hammertoe System	Medartis AG	HWC	Class II	2021-12-09
K213371	Disposable Medical Nitrile Examination Gloves (Model:XYS-001)	Anhui Xinyisheng Medical Technology Co.,Ltd	LZA	Class I	2021-12-09
K213359	SeaSpine WaveForm, C Interbody System	SeaSpine Orthopedics Corporation	OVE	Class II	2021-12-09
K213149	VOCO Retraction Paste	Voco GmbH	MVL	Unclassified	2021-12-09
K212466	LVivo Seamless	Dia Imaging Analysis, Ltd.	QIH	Class II	2021-12-09
K212329	Plasma IQ	Neauvia North America, Inc	GEI	Class II	2021-12-09
K212034	LOSPA TKR System	Corentec Co., Ltd.	JWH	Class II	2021-12-09
K211949	AirStrip ONE Web Client with Alarm Communication Management (ACM)	AirStrip Technologies, Inc.	MSX	Class II	2021-12-09
K201764	Infinity Acute Care System (IACS) Monitoring Solution	Draeger Medical Systems, Inc.	MHX	Class II	2021-12-09
K213156	BD Nano 2nd Gen Pen Needle	Becton Dickinson & Co	FMI	Class II	2021-12-08
K212983	Injectable Root Canal Bioceramic Sealer	Beijing C-Root Dental Medical Devices Co., Ltd.	KIF	Class II	2021-12-08
K212639	Disposable Medical Nitrile Examination Gloves (Non sterile)	Jiangsu Nanfang Medical Co., Ltd.	LZC	Class I	2021-12-08
K212573	PicoLO Premium	Laseroptek	GEX	Class II	2021-12-08
K212524	Anteralign Spinal System with Titan nanoLOCK Surface Technology	Medtronic Sofamor Danek USA Inc	MAX	Class II	2021-12-08
K212075	ShurFit Lumbar Interbody System	Precision Spine, Inc.	MAX	Class II	2021-12-08
K211898	ASAHI PCI Guide Wire ASAHI CONFIANZA PRO 8-20	Asahi Intecc Co., Ltd.	DQX	Class II	2021-12-08
K211629	Infrared forehead thermometer LD-FT-100B	HONSUN (NANTONG) Co., Ltd.	FLL	Class II	2021-12-08
K211487	MAF Guard	Maf Clothing Pvt Ltd Unit-3	FXX	Class II	2021-12-08
K210817	C&B 5.0 Hybrid	ARUM DENTISTRY Co., Ltd.	EBG	Class II	2021-12-08
K213512	DERMABOND PRINEO Skin Closure System	Ethicon, Inc	OMD	Class II	2021-12-07
K213303	Makoto Intravascular Imaging System, TVC-MC10/TVC-MC10i, Dualpro IVUS + NIRS Imaging Catheter ,TVC-C195-42, Peripheral 014 Imaging Catheter, TVC-E195-42	Nipro Vascular Innovations Americas, Inc.	IYO	Class II	2021-12-07
K212438	Comfortpro	Thai Rubber Industry Company Limited	LYY	Class I	2021-12-07
K212302	BAYLAB 3-Ply Surgical Mask (BEACON I)	Baylab USA	FXX	Class II	2021-12-07
K211309	endomina system	Endo Tools Therapeutics S.A	OCW	Class II	2021-12-07
K213115	CHENA-C Spacer System	Kahtnu Surgical, Inc.	ODP	Class II	2021-12-06
K213096	Al-Rad Companion (Pulmonary)	Siemens Medical Solutions USA, Inc.	JAK	Class II	2021-12-06
K212852	Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle, Tridemt(TM) Endoscopic Ultrasound Aspiration Needle	Micro-Tech (Nanjing) Co., Ltd.	ODG	Class II	2021-12-06
K212827	Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs	JR Engineering and Medical Technologies (M) Sdn Bhd	LZC	Class I	2021-12-06
K212548	LUXEN CL Dental Liquid	Dentalmax Co., Ltd	EIH	Class II	2021-12-06
K212381	VersaTap, VersaLat, DueLock, VersaTi, MiniTi	Ortho-Design	MBI	Class II	2021-12-06
K212235	Surgical Face Mask	Shanghai Yunqing Industrial Co., Ltd.	FXX	Class II	2021-12-06
K211804	3Delta Crown	Deltamed GmbH	EBF	Class II	2021-12-06
K211772	PMW01 Procedure Mask Level 1	Defender Safety, Inc.	FXX	Class II	2021-12-06