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 199 of 3528

510(k) clearances, page 199 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K231149	qXR-CTR	Qure.ai Technologies Inc	QIH	Class II	2023-09-22
K231092	T-Shape 2	B&M S.r.l. Marketing Nel Benessere	NUV	Class II	2023-09-22
K230980	MicroMatrix® Flex	ACell, Inc	KGN	Unclassified	2023-09-22
K230350	VISULAS yag	Carl Zeiss Meditec Inc	HQF	Class II	2023-09-22
K230067	Para-Fix External Fixation System	New Paradigm Biomedical, LLC	LXT	Class II	2023-09-22
K223921	Access CEA	Siemens Healthcare Diagnostics Inc.	DHX	Class II	2023-09-22
K223659	Jazz	Ai Medical AG	LLZ	Class II	2023-09-22
K221817	ALFIS Vitamin D, ALFIS-3 Analyzer	Immunostics, Inc.	MRG	Class II	2023-09-22
K220179	High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air Motors	Foshan Coxo Medical Instrument Co., Ltd.	EFB	Class I	2023-09-22
K232569	Caremibrain	General Equipment for Medical Imaging, S.A.	KPS	Class II	2023-09-21
K232159	QEVO System	Carl Zeiss Meditec Inc	GWG	Class II	2023-09-21
K231678	Overjet Periapical Radiolucency Assist	Overjet	MYN	Class II	2023-09-21
K231401	Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva	Poly Medicure Limited	FOZ	Class II	2023-09-21
K231248	Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring Platform	Edwards Lifesciencess, LLC	DYG	Class II	2023-09-21
K230767	Pelvic Floor Muscle Stimulator	Nanjing Vishee Medical Technology Co., Ltd.	KPI	Class II	2023-09-21
K230467	Btl-899F	BTL Industries, Inc	GEI	Class II	2023-09-21
K230226	Integrity-SI® Fusion System	OsteoCentric Technologies,Inc	OUR	Class II	2023-09-21
K230193	Servator P Plus SALF Solution	S.A.L.F. SpA	KDN	Class II	2023-09-21
K230102	Smart double sides wearable breast pump, Electric bilateral breast pump	Huizhou LVB Maternal and Infant Supplies Co., Ltd.	HGX	Class II	2023-09-21
K223354	EGIS Biliary Single Bare Stent	S&G Biotech, Inc.	FGE	Class II	2023-09-21
K223214	Powder-Free Nitrile Examination Gloves	Global Protection Corp.	LZA	Class I	2023-09-21
K232592	Citrelock® Duo	Acuitive Technologies	MBI	Class II	2023-09-20
K232583	Catalyst R1 Reverse Shoulder System	CATALYST ORTHOSCIENCE Inc	PHX	Class II	2023-09-20
K232582	Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler Set	Ambu A/S	EOQ	Class II	2023-09-20
K232556	DePuy 3D Additive TriFlange Acetabular Cup and DePuy TriFlange II Acetabular Cup System	Depuy Ireland UC	LPH	Class II	2023-09-20
K231894	LED Spectrum therapy instrument	Shenzhenshi Sincoheren S&T Development Co., Ltd.	GEX	Class II	2023-09-20
K231854	1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIM	Stryker Corp.	OWN	Class II	2023-09-20
K231385	Rology Teleradiology Platform (v.1.22.1103)	Rology, Inc.	LLZ	Class II	2023-09-20
K231342	Insufflator (OPTO-IFL1000)	Guangdong Optomedic Technologies, Inc.	HIF	Class II	2023-09-20
K230692	TULSA-PRO System	Profound Medical Inc.	PLP	Class II	2023-09-20
K230239	AirSeal iFS System; AirSeal dV Solution	ConMed Corporation	HIF	Class II	2023-09-20
K230043	Insulin Pen Needle	Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.	FMI	Class II	2023-09-20
K230011	Mpact Extension	Medacta International SA	LPH	Class II	2023-09-20
K223913	Socrates Aspiration System	Scientia Vascular	NRY	Class II	2023-09-20
K223421	MedCAD AccuPlan Orthopedics System	MedCAD	PBF	Class II	2023-09-20
K223179	Cholestech LDX ™ System	Alere San Diego, Inc.	CGA	Class II	2023-09-20
K213987	ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls	Biokit, S.A.	MXJ	Class II	2023-09-20
K232178	GXR-ES/ECS Diagnostic X-Ray System, (Models GXR-ES series, GXR-ECS series)	DRGEM Corporation	KPR	Class II	2023-09-19
K231802	Millipede 088 Access Catheter	Perfuze	QJP	Class II	2023-09-19
K231281	Aquilion Serve (TSX-307A/1) V1.3	Canon Medical Systems Corporation	JAK	Class II	2023-09-19
K231106	Accuject Refra Injector AR2900	Medicel AG	MSS	Class I	2023-09-19
K230966	angiOCCLUDE Ligating Clips	A2 Medical Systems, LLC	FZP	Class II	2023-09-19
K222948	Q Distal Access Catheter	Mivi Neuroscience, Inc.	QJP	Class II	2023-09-19
K221309	AI100 with Shonit	Sigtuple Technologies Pvt., Ltd.	JOY	Class II	2023-09-19
K232544	Apollo ESG NXT System, Apollo REVISE NXT System	Apollo Endosurgery, Inc.	QTD	Class II	2023-09-18
K232530	Stable-L Standalone Lumbar Interbody System, Stable-C Interbody System	Nexus Spine, L.L.C.	OVD	Class II	2023-09-18
K232513	X-Twist Biocomposite Suture Anchor	Parcus Medical, L.L.C.	MAI	Class II	2023-09-18
K232172	BTL-785BNF Handpiece	BTL Industries, Inc	NFO	Class II	2023-09-18
K231832	Access Myoglobin	Siemens Healthcare Diagnostics Inc.	DDR	Class II	2023-09-18
K231663	The AVEOtsd (Tongue Stabilizing Device) Mouthpiece	Innovative Health Technologies (NZ) Limited	LRK	Class II	2023-09-18