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 2026-11-02, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,132 of the 176,529 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	2,732

176,529 records, page 1057 of 3531

510(k) clearances, page 1057 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K091962	Polyscope Flexible Endoscopy Catheter; 10,000 Pixel Fiber Optic; Xenon Light Source, Model Ls-200	Lumenis Ltd	ODF	Class II	2009-09-30
K091094	Parcus V-Lox Peek Cf Suture Anchor, Models: 10253, 10254, 10263, 10264	Parcus Medical, L.L.C.	MBI	Class II	2009-09-30
K091093	Parcus Ppek Cf Interference Screw	Parcus Medical, L.L.C.	HWC	Class II	2009-09-30
K092851	Model Gdch-2000	Global Dental Direct, Inc.	EIA	Class I	2009-09-29
K092278	Gyrus Acmi Invisio Digital Hysteroscope, Model Idh-4	Gyrus ACMI, Inc.	HIH	Class II	2009-09-29
K092020	Aadva Zr Coloring Liquid	GC America Inc.	EIH	Class II	2009-09-29
K091637	Cortrak Enteral Access Device, Model 20-0900	Halyard Health	KNT	Class II	2009-09-29
K091014	Journey Bcs Knee System	Smith & Nephew, Inc.	JWH	Class II	2009-09-29
K090353	Perimeter Interbody Fusion Device	Medtronic Sofamor Danek	MAX	Class II	2009-09-29
K090117	Autosafe-Reflex Safety Huber Infusion Set, Autosafe Advantage Safety Huber Infusion Set	Autosafe-Reflex, Inc.	FMI	Class II	2009-09-29
K083378	Synergy	Innerspace, Inc.	GWM	Class II	2009-09-29
K083157	Hs Amica	H.S. Hospital Service S.p.A.	NEY	Class II	2009-09-29
K092756	Ge Vscan Compact Diagnostic Ultrasound System	GE Vingmed Ultrasound AS	ITX	Class II	2009-09-28
K092715	Iroot Bp Plus	Innovative BioCeramix, Inc	KIF	Class II	2009-09-28
K091998	Robotic Arm Interactive Orthopedic System-Hip	Mako Surgical Corp.	OLO	Class II	2009-09-28
K091981	Lightlas 577 Medical Optical Pumped Semiconductor Laser	Lightmed Corp.	HQF	Class II	2009-09-28
K091947	S8 Aspen with H4i Plus	ResMed Corp	BZD	Class II	2009-09-28
K091920	Atlantis Abutment in Zirconia, Atlantis Gemini Abutment for Nobel Replace Implants, Atlantis Gemini + Abutment for Nobel	Astra Tech, Inc.	NHA	Class II	2009-09-28
K091919	Devilbiss Intellipap/sleepcube Bilevel S/st	Sunrise Medical, Inc.	BZD	Class II	2009-09-28
K091828	Sheathesiso Ultrasound Transducer Cover	Sheathing Technologies Inc	ITX	Class II	2009-09-28
K091697	Spider Surgical Instruments, Models 90004, 90005, 90007, 90009, 90010, 90012, 90013, 90015	Asensus Surgical, Inc.	GCJ	Class II	2009-09-28
K091246	Iled 3 Mobile (I300m), Trulight 5500 Mobile (T500m), Trulight 5300 Mobile (T300m)	Trumpf Medizin Systeme GmbH + Co. KG	FSS	Class II	2009-09-28
K091228	Spinewand Surgical Device	ArthroCare Corporation	GEI	Class II	2009-09-28
K091218	Dbx Demineralized Bone Matrix Putty	Musculoskeletal Transplant Foundation d/b/a/ MTF Biologics	MQV	Class II	2009-09-28
K090557	Given Pillcam Platform Will Pillcam Sb Capsules, Eso Capsules, Given Agile Patency System	Given Imaging Ltd.	NSI	Class II	2009-09-28
K090387	Kainos+	Signus Medizintechnik GmbH	MQV	Class II	2009-09-28
K083840	Msi Medserv International-Rigid Endoscope	Msi Medserv International Deutschland GmbH	GCM	Class II	2009-09-28
K092683	Digital Wrist Blood Pressure Monitor, Model Ld 1143	Shanghai Little Doctor Co. Limited	DXN	Class II	2009-09-25
K092646	Synthes (USA) Trochanteric Fixation Nail (Tfn) Screw	Synthes (USA) Products LLC	HSB	Class II	2009-09-25
K092633	Osom Influenza A&b Test , Model Pn190	Genzyme Corporation	PSZ	Class II	2009-09-25
K092631	Mantis Redux Spinal System	Howmedica Osteonics Corp	NKB	Class II	2009-09-25
K092629	Snm Firmgrip	Flexicath, Ltd.	FOZ	Class II	2009-09-25
K092626	Modification to: Expedium Spine System	DePuy Spine, Inc.	NKB	Class II	2009-09-25
K092624	Firebird Spinal Fixation System	Blackstone Medical, Inc.	NKB	Class II	2009-09-25
K092621	Pascal Streamline Photocoagulator	Iridex Corporation	HQF	Class II	2009-09-25
K092415	Powder-Free Vinyl Patient Examination Gloves	Shijiazhuang Elegance Plastic Product	LYZ	Class I	2009-09-25
K092248	Spi Customizable Gingiva Former	Thommen Medical AG	NHA	Class II	2009-09-25
K092247	Synthes Locking Hand Plates	Synthes (USA) Products LLC	HRS	Class II	2009-09-25
K092193	Spinal USA Interbody Cages	Spinal USA	MAX	Class II	2009-09-25
K092012	Primagard Delta Fit 80,120, 160 Surgical Face Mask (Small, Medium, Large) Model Pg4-7061,-7071,-7081, Pg4-7062, 7072-70	Primed Medical Products Inc.	FXX	Class II	2009-09-25
K091946	Vlift-S Vertebral Body Replacement System, Models 488812Xx, 488814Xx, 488816Xx, 488818Xx	Howmedica Osteonics Corp	MQP	Class II	2009-09-25
K091904	Nobelprocera Zi Abutment	Nobel Biocare AB	NHA	Class II	2009-09-25
K091826	Elegant	3M Espe AG Dental Products	EIH	Class II	2009-09-25
K091825	Hi-Torque Progress Guide Wire Family	Abbott Vascular	DQX	Class II	2009-09-25
K091735	Dc Provi Cem Esthetic, Esthetic Multi F, Implant	S & C Polymer GmbH	EMA	Class II	2009-09-25
K091601	Elecys Anti-Ccp Calcheck	Roche Diagnostics GmbH	JJX	Class I	2009-09-25
K091411	Kneealign System	OrthAlign, Inc.	OLO	Class II	2009-09-25
K091280	Freedom Total Knee Cruciate Retaining (Cr) Femoral Component	Maxx Orthopedics Inc.	JWH	Class II	2009-09-25
K091214	Footprint Medical Silicone Umbilical Catheter	Footprint Medical Inc.	FOS	Class II	2009-09-25
K091213	Footprint Medical Umbilical Catheter, Dual Lumen	Footprint Medical Inc.	FOS	Class II	2009-09-25