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 939 of 3530

510(k) clearances, page 939 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K111019	Surgimap (Tm) Spine	Nemaris, Inc.	LLZ	Class II	2011-09-30
K110904	Randox Liquid Urine Control Levels 2 and 3	Randox Laboratories, Limited	JJY	Class I	2011-09-30
K110846	Randox Urinalysis Controls, Levels 1 and 2	Randox Laboratories, Limited	JJW	Class I	2011-09-30
K110474	Philips Intellivue Tcg10	Philips Medizinsysteme Boeblingen GmbH, Cardiac an	LKD	Class II	2011-09-30
K110400	Taperloc Complete Microplasty Stem	Biomet Manufacturing Corp	KWA	Class III	2011-09-30
K110327	Ldr Spine Roi-a Interbody Fusion System	Ldr Spine USA	OVD	Class II	2011-09-30
K110165	Freerider Model Luggie Model 168-4It	Freerider Luggie Scooters, Inc.	INI	Class II	2011-09-30
K110140	Neurovision Nerve Locator Monitor	Neurovision Medical Products Inc	GWF	Class II	2011-09-30
K103327	Discovery Mr750w 3.0T	GE Healthcare Japan Corporation	LNH	Class II	2011-09-30
K102673	Rheumatoid Factor Immunological Test System	Phadia AB	DHR	Class II	2011-09-30
K101273	Dynamic ECG System Model Tlc5000	Contec Medical System Co., Ltd.	MLO	Class II	2011-09-30
K112584	5Mm/8mm Harmonic Ace(tm) Curved Shears, Disposable Harmonic Ace(tm) Insert, Disposable Harmonic(tm) Curved Shears Insert	Intuitive Surgical, Inc.	NAY	Class II	2011-09-29
K112525	D731 Micro 27 Ph.i.s.i.o. and D733 Micro 40 Ph.i.s.o. Arterial Filters	Parexel International	DTM	Class II	2011-09-29
K112434	Bd Oral/enteral Syringe with Bd Univia Connection	BD Medical Surgical	KNT	Class II	2011-09-29
K112226	Hydrocoil Embolic System (Hes)	Terumo Cardiovascular Systems Corporation	HCG	Class II	2011-09-29
K112136	Top Drape Sterile, Top Drape-Non Sterile, Bottom Drape- Sterile, Bottom Drape	Kunshan Jiehong Nonwoven Product Co., Ltd.	KKX	Class II	2011-09-29
K112131	Neodyne Dressing	Neodyne Biosciences, Inc.	MDA	Class I	2011-09-29
K111943	Agills Pf Delivery System	St. Jude Medical, Cardiac Rhythm Management Divisi	DYB	Class II	2011-09-29
K111916	Conformis Iuni Unicondylar Knee Replacement System	ConforMIS, Inc.	HSX	Class II	2011-09-29
K111878	Protexis Latex Blue with Neu-Thera Powder-Free Surgical Gloves	Medtronic, Inc.	KGO	Class I	2011-09-29
K111832	Paladon Ultra Powder (Pink), Paladon Ultra Liquid	Kulzer GmbH	EBI	Class II	2011-09-29
K111816	Equimatrix	Luitpold Pharmaceuticals, Inc.	NPM	Class II	2011-09-29
K111687	EMG System	Myotronics-Noromed, Inc.	HCC	Class II	2011-09-29
K111570	Minispacer(r) Mdi Adapter with Counter Incrementing Actuator	Thayer Medical Corportation	CAF	Class II	2011-09-29
K111522	Chartis Catheter Model Chr-Ca-12.0	PULMONX, Corp.	CBI	Class II	2011-09-29
K111443	X12 Sterile Reflective Marker Sphere	Pinsco Inc. dba B & L Engineering	OLO	Class II	2011-09-29
K111351	Truecare Biomedix Intravascular Administration Set, Truecare Biomedix Extension Set	Us Infusion dba Truecare Biomedix	FPA	Class II	2011-09-29
K111350	Medicam Evolux, Evostar, Evolight and Evolase Pulsed Light System	Medicam, Inc.	ONF	Class II	2011-09-29
K110741	Scepter C Occlusion Balloon Catheter	Terumo Cardiovascular Systems Corporation	MJN	Class II	2011-09-29
K110606	Mv Intradermic Needles; Magic Needle; Magic Needle	M.V.S.R.L.	FMI	Class II	2011-09-29
K112556	Adm and Adm/mdm Duration Inserts, Adm and Adm/mdm X3 Inserts	Howmedica Osteonics Corp	MEH	Class II	2011-09-28
K112496	Pioneer Crossfuse II Ibf/vbr System	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)	MAX	Class II	2011-09-28
K112477	Palindrome H, Si, Hsi Chronic Catheter	Medtronic, Inc.	NYU	Class II	2011-09-28
K111553	Spinefrontier Lumbar Ibf System	SPINEFRONTIER, Inc. dba LESspine Innovations	MAX	Class II	2011-09-28
K111475	Auriga Xl	Starmedtec GmbH	GEX	Class II	2011-09-28
K103217	Lite-Med Lm-9200 Elma	Lite-Med, Inc.	LNS	Class II	2011-09-28
K112726	Sonix Ultrasound Scanner	Ultrasonix Medical Corporation	IYN	Class II	2011-09-27
K112555	Cd Horizon(r) Spinal System	Medtronic Sofamor Danek USA Inc	NKB	Class II	2011-09-27
K112371	Logiq P3	GE Healthcare	IYN	Class II	2011-09-27
K112129	Vitek(r) 2 Streptococcus Clindamycin	bioMerieux, Inc.	LON	Class II	2011-09-27
K111951	Isoamp Hsv Assay	Biohelix Corporation	OQO	Class II	2011-09-27
K111837	Radial Artery Compression Tourniquet	Lepu Medical Technology (Beijing) Co., Ltd	DXC	Class II	2011-09-27
K111697	Amo Whitestar Signature Phacoemulsification System	Advanced Medical Optics, Inc.	HQC	Class II	2011-09-27
K111516	Nmr Lipoprofile (R) Test and Nmr Profiler	Liposcience	LBS	Class I	2011-09-27
K110800	Meta-Lock Suture Anchor System	Tarsus Medical, Inc.	MBI	Class II	2011-09-27
K110673	Hi Vision Ascendus Diagnostic Ultrasound Scanner	FUJIFILM Healthcare Americas Corporation	IYN	Class II	2011-09-27
K110290	Exeter Hip Stem	Howmedica Osteonics Corp	JDI	Class II	2011-09-27
K103396	Cool Blood Glucose Monitoring System, Blood Glucose Meter, Cool Control Solution	I-SENS, Inc.	NBW	Class II	2011-09-27
K112524	Hairmax Lasercomb	Lexington International, LLC	OAP	Class II	2011-09-26
K112482	Selectra Slitter Tool	BIOTRONIK AG	DQY	Class II	2011-09-26