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 2026-10-29, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 804 of 3530

510(k) clearances, page 804 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K132033	Bm3/bm3 Plus	Noblitt & Rueland	MWI	Class II	2013-12-04
K131961	Heine Beta 200(R) Ophthalmoscope	Heine Optotechnik GmbH & Co. KG.	HLJ	Class II	2013-12-04
K131957	Mr810respiratory Humidifier, 900Mr810 Adult Single Limb Circuit, 900Mr810e Adult Dual Limb Circuit	Fisher & Paykel Healthcare, Inc.	BTT	Class II	2013-12-04
K130375	Self-Retaining Bicanaliculus Intubaton Set II	Fci SAS (France Chirurgie Instrumentation)	OKS	Unclassified	2013-12-04
K122952	Nipro Pureflux-L Hemodialyzer	Nipro Medical Corporation	FJI	Class II	2013-12-04
K133314	Harmonic Focus Shears + Adaptive Tissue Technology	Ethicon Endo-Surgery Inc	LFL	Unclassified	2013-12-03
K133202	Hem-O-Lok Ligating Clip	Teleflex Medical	FZP	Class II	2013-12-03
K133185	21.3 Inch (54 Cm) Color Lcd Monitor Ccl358i2 (Cl21358)	JVCKENWOOD Corporation	LLZ	Class II	2013-12-03
K133181	21.3 Inch (54 Cm) Color Lcd Monitor Ccl258i2 (Cl21258)	JVCKENWOOD Corporation	LLZ	Class II	2013-12-03
K132974	Aquamantys 2.3 Bipolar Sealer, Evs 4.0 Epidural Vein Sealer, Mini Evs 3.4 Epidural Vein Sealer, Sbs 5.0 Sheathed Bipolar	Medtronic Navigation, Inc	GEI	Class II	2013-12-03
K132743	Harvesting Cannula	Maquet Cardiovascular LLC	GEI	Class II	2013-12-03
K132742	M-Vu Breast Density	Vucomp, Inc.	LLZ	Class II	2013-12-03
K132463	Cianna Medical Permanent Tissue Marker and Delivery System	Cianna Medical, Inc.	NEU	Class II	2013-12-03
K131929	Surveyor Central Station	Mortara Instrument, Inc.	MHX	Class II	2013-12-03
K130329	Surgiseal Topical Skin Adhesive	Adhezion Biomedical, LLC	MPN	Class II	2013-12-03
K123474	Avant Laser	Avant Wellness Systems Inc	ILY	Class II	2013-12-03
K133437	1St Mtp Plate	Osteomed	HRS	Class II	2013-12-02
K132896	Cj-Type: Metal Handle with Guide Tube, Pj-Type: Plastic Handle with Guide Tube, Cb-Type: Metal Handle without Guide Tube	Asia-Med GmbH and CO KG	MQX	Class II	2013-12-02
K132514	Kinsa Smart Thermometer	Kinsa, Inc.	FLL	Class II	2013-12-02
K132270	Cobas Ct/ng V2.0 Test	Roche Molecular Systems Inc	LSL	Class II	2013-12-02
K132134	Optifix Absorbable Fixation System	C.R. Bard Inc	GDW	Class II	2013-12-02
K130512	Nitiflex Stapes Prosthesis, Detroit Piston, Skarzynski Piston, Roberson Stapes Prosthesis	Heinz Kurz GmbH Medizintechnik	ETB	Class II	2013-12-02
K121812	Sonixgps	Ultrasonix Medical Corporation	BSP	Class II	2013-12-02
K133420	Tranquill Barbed Device	Surgical Specialties Corp. dba Angiotech	NEW	Class II	2013-11-29
K132970	Lessray	Saferay Spine, LLC	OWB	Class II	2013-11-29
K132848	Piezosurgery Flex	Mectron S.p.A.	JDX	Class II	2013-11-29
K132726	Iceplex C. Difficile Assay Kit, Iceplex System	Primeradx	OZN	Class II	2013-11-29
K131686	Inomax Dsir (Delivery System)	Ino Therapeutics/Ikaria	MRN	Class II	2013-11-29
K133329	Ugeo Ws80a Diagnostic Ultrasound System	Samsung Medison Co., Ltd.	IYN	Class II	2013-11-27
K133282	Reverse Medical Micro Vascular Plug (Mvp) System	Reverse Medical Corporation	KRD	Class II	2013-11-27
K133091	Zip Mis Interspinous Fusion System	Aurora Spine, Inc.	PEK	Class II	2013-11-27
K133086	Title 2 Polyaxial Spinal System	Zimmer Spine, Inc.	NKB	Class II	2013-11-27
K133061	Espin System	Nlt Spine, Ltd.	HRX	Class II	2013-11-27
K132687	E-Cube 7	ALPINION MEDICAL SYSTEMS Co., Ltd.	IYN	Class II	2013-11-27
K132658	Hemoclip Traditional Ligating Clips, Hemoclip Plus Ligating Clips, Horizon Ligting Clips	Teleflex Medical	FZP	Class II	2013-11-27
K132231	Mylabseven, Mylabalpha	Esaote S.p.A.	IYN	Class II	2013-11-27
K132201	Synmax Synthetic Examination Vinyl Gloves, Powder Free, Blue Color	Zibo Intco Medical Products Company Limited	LYZ	Class I	2013-11-27
K131591	Free Gliding Slipped Capital Femoral Epiphysis Screw (Scfe)	Orthopediatrics Canada ULC	HWC	Class II	2013-11-27
K131390	Jusha-M52c Medical Display	Nanjing Jusha Display Technology Co., Ltd	LLZ	Class II	2013-11-27
K131383	X10 Headset with X-Series Basic Software, X24 Headset with X-Series Basic Software	Advanced Brain Monitoring, Inc.	GWQ	Class II	2013-11-27
K131142	Genesis LED Wands	Genesis Biosystems Inc.	GEX	Class II	2013-11-27
K131025	Archon Anterior Cervical Plate System	NuVasive Inc	KWQ	Class II	2013-11-27
K131016	Rogs	Molecular Products Inc	CAW	Class II	2013-11-27
K130565	Specular Microscope Cem-530	Nidek Co., Ltd.	NQE	Class II	2013-11-27
K133330	C.f.a.s. Proteins, C.f.a.s. Pac, Precicontrol Clinchem Multi 1 & 2, Precinorm Protein & Precipath Protein	Roche Diagnostics GmbH	JIX	Class II	2013-11-26
K132822	Bd Max Staphsr Assay, Instrument	Geneohm Sciences Canada, Inc. (BD Diagnostics)	NQX	Class II	2013-11-26
K132795	Cyberwand Sterile Probe Set	Cybersonics, Inc.	FFK	Class II	2013-11-26
K132740	Spinefrontier Lesplasty Posterior Cervical Laminoplasty System	SPINEFRONTIER, Inc. dba LESspine Innovations	NQW	Class II	2013-11-26
K132699	Aigis Rx N (Medium), Aigis Rx N (Large)	Tyrx, Inc.	FTL	Class II	2013-11-26
K132624	Triathlon Tritanium Metal-Backed Patella	Stryker Orthopaedics	MBH	Class II	2013-11-26