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 2026-10-22, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 572 of 3529

510(k) clearances, page 572 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K171224	Arctic Sperm Cryopreservation Medium	FUJIFILM Biosciences Inc.	MQL	Class II	2017-08-31
K171010	Latitude EV Total Elbow Arthroplasty	TORNIER Inc.	JDB	Class II	2017-08-31
K170599	SureFlo EVD Catheter	Arkis Biosciences, Inc.	JXG	Class II	2017-08-31
K170031	Internal Octa Implant System	Ebi, Inc.	DZE	Class II	2017-08-31
K163423	Orthopantomograph OP300	Palodex Group Oy	OAS	Class II	2017-08-31
K163402	NLZ Motor System	Nakanishi Inc.	EBW	Class I	2017-08-31
K163337	Midmark and Ritter M9 and M11 UltraClave® Automatic Sterilizers and Ritter M9D AutoClave® Automatic Sterilizer	Midmark Corp	FLE	Class II	2017-08-31
K162613	Integrated Catch-up Freedom Syringe Driver Infusion System	Repro-Med Systems, Inc. dba Rms Medical Products	FRN	Class II	2017-08-31
K162533	Kelowna GYN and Crook Prostate Templates	Varian Medical Systems, Inc.	JAQ	Class II	2017-08-31
K172274	The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.00025-8µg/mL	Thermo Fisher Scientific Oy	JWY	Class II	2017-08-30
K172049	CryoIQ DERM, CryoIQ PRO, CryoIQ EquiMED	Cry IQ AB	GEH	Class II	2017-08-30
K172021	LigaPASS	Medicrea International	OWI	Class II	2017-08-30
K171985	Astroglide O Oil Personal Lubricant & Massage Oil	Biofilm, Inc.	NUC	Class II	2017-08-30
K171626	truFreeze System	CSA Medical	GEH	Class II	2017-08-30
K171540	Refobacin Bone Cement R	Zimmer GmbH	LOD	Class II	2017-08-30
K171321	K2M Navigation Instruments	K2M, Inc	OLO	Class II	2017-08-30
K170564	MyndMove System, MyndMove Functional Electrical Stimulator	Myndtec Inc	GZI	Class II	2017-08-30
K170467	Microlife Upper Arm Automatic Digital Blood Pressure Monitor	Microlife Intellectual Property GmbH	DXN	Class II	2017-08-30
K163628	Idylla Respiratory (IFV-RSV) Panel	Janssen Pharmaceutica NV	OCC	Class II	2017-08-30
K163485	SmartTouch	Adherium (Nz), Ltd.	CAF	Class II	2017-08-30
K171896	Feminine Personal Trainer (FPT)	Ralston Group	HIR	Class II	2017-08-29
K171741	Laport	Sejong Medical Co., Ltd.	GCJ	Class II	2017-08-29
K171592	CrossFT™ Knotless Biocomposite Suture Anchor with Disposable Driver	ConMed Corporation	MAI	Class II	2017-08-29
K171506	Easyscreen	MAICO Diagnostics GmbH	EWO	Class II	2017-08-29
K171329	Altus Spine Titanium Interbody Fusion System	Altus Partners	MAX	Class II	2017-08-29
K171039	Assut Filbloc Permanent Sutures	Assut Europe S.p.A.	GAW	Class II	2017-08-29
K170958	ChitoPulse 9in / 23 cm, ChitoPulse 12in / 30.5 cm, ChitoPulse 15in / 38 cm	Tricol Biomedical, Inc.	DXC	Class II	2017-08-29
K163385	Cortex Dental Implant System	Cortex Dental Implants Industries Ltd.	DZE	Class II	2017-08-29
K162943	SyMRI	Syntheticmr AB	LNH	Class II	2017-08-29
K162165	ambIT PCAPIB, ambIT PIB, ambIT PIBPCA, ambIT PIEB, and ambIT Programmable Intermittent Pump	Summit Medical Products, Inc.	MEA	Class II	2017-08-29
K172131	2 Hole Lateral Plating System	Life Spine	KWQ	Class II	2017-08-28
K171567	IRIX-A Lumbar Integrated Fusion System	Xtant Medical Holdings, Inc.	OVD	Class II	2017-08-28
K171561	Dextera MicroCutter 30 Blue Reload, Dextera MicroCutter 30 Curved Tip Blue Reload, Dextera MicroCutter 30 White Reload, Dextera MicroCutter 30 Curved Tip White Reload	Dextera Surgical, Inc.	GDW	Class II	2017-08-28
K171181	PROCOTYL® PRIME E-CLASS™ XLPE Liner	Microport Orthopedics Inc.	LZO	Class II	2017-08-28
K170987	Captus Vascular Retrieval System	Avantec Vascular Corp.	MMX	Class II	2017-08-28
K170722	Moxxly Flow Collection System	Moxxly, Inc.	HGX	Class II	2017-08-28
K170010	Salle Intraoperative Pyeloplasty Stent Set	Cook Incorporated	FAD	Class II	2017-08-28
K162543	Reverse Pull Adjustable Facemask	Sawbros Industries Pvt Ltd	DZB	Class II	2017-08-28
K172327	VMA™ System version 3.0	Wenzel Spine	LLZ	Class II	2017-08-25
K172207	Standard Supreme Sterilization Wrapper	Standard Textile Co., Inc.	FRG	Class II	2017-08-25
K172073	Hi-Torque Command 18 Guide Wire	Abbott Vascular	DQX	Class II	2017-08-25
K172002	Catalys Precision Laser System	Advanced Medical Optics, Inc.	OOE	Class II	2017-08-25
K171716	Skr 3000	Konica Minolta, Inc.	MQB	Class II	2017-08-25
K171560	OTIS Optical Coherence Tomography System	Perimeter Medical Imaging, Inc.	NQQ	Class II	2017-08-25
K171487	Sirius MRI Marker NS	C4 Imaging LLC	KXK	Class II	2017-08-25
K171346	Sapphire Sets	Abbott Medical	MRZ	Class II	2017-08-25
K171191	Hexagen Derm	Global Health Solutions, LLC	FRO	Unclassified	2017-08-25
K171124	Nihon Kohden Wireless Input Unit WEE-1200	Nihon Kohden Corp.	GWQ	Class II	2017-08-25
K171104	Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Blue, Cobalt Blue)	Yty Industry (Manjung) Sdn. Bhd.	LZA	Class I	2017-08-25
K170136	Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy Drugs	Shandong Feiyang Professional Gloves Co., Ltd.	LZA	Class I	2017-08-25