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 554 of 3529

510(k) clearances, page 554 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K172222	8ch Flex Suite	Shenzhen RF Tech Co., Ltd.	MOS	Class II	2017-12-08
K171928	Med-Hot Thermal Imaging Systems	Med-Hot Thermal Imaging, Inc.	LHQ	Class I	2017-12-08
K171677	Clear Guide SCENERGY	Clear Guide Medical	JAK	Class II	2017-12-08
K171553	W&H Assistina Twin	W & H DentalWerk Buermoos GmbH	EFB	Class I	2017-12-08
K171186	Cerebrotech CMS-5000	Cerebrotech Medical Systems	QAF	Class II	2017-12-08
K173458	ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System	Orthofix SRL	HSB	Class II	2017-12-07
K173267	MasterLoc Stem: Lateralized Plus	Medacta International SA	LZO	Class II	2017-12-07
K173117	NuVasive® VersaTie™ System	NuVasive Inc	OWI	Class II	2017-12-07
K173000	Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee 2300 Digital Color Doppler Ultrasound Imaging System	Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)	IYN	Class II	2017-12-07
K172912	MicroScan Dried Gram-Negative MIC/Combo Panels with Ciprofloxacin-S (0.004 – 8 µg/mL)	Siemens Healthcare Diagnostics Inc.	LTT	Class II	2017-12-07
K172908	Q-Switched Nd:YAG Laser System	Ami, Inc.	GEX	Class II	2017-12-07
K172734	Single Use Electrosurgical Snare SD-400	Olympus Medical Systems Corp.	FDI	Class II	2017-12-07
K172578	Equipment Pouch	WickiMed (Huizhou) Medical Equipment Manufacturing Co., Ltd.	GCJ	Class II	2017-12-07
K172270	gammaCore-2	Eletrocore, LLC	PKR	Class II	2017-12-07
K172010	gel-e Bandage	Gel-E, Inc. (Formerly Remedium Technologies, Inc.)	KGN	Unclassified	2017-12-07
K171513	Lunderquist Extra Stiff Wire Guide	William Cook Europe ApS	DQX	Class II	2017-12-07
K171336	Cystoscope 4.0mm autoclavable 0° WL 302mm; Hysteroscope 4.0mm autoclavable 0° WL 302mm; Cysto-Urethroscope Sheath 19 Fr.; Bridge for 17-25 Fr. Cysto-Urethroscope Sheath	Henke-Sass Wolf, GmbH.	FAJ	Class II	2017-12-07
K171198	NeuViz 16 Essence Multi-slice CT Scanner System	Neusoft Medical Systems Co., Ltd.	JAK	Class II	2017-12-07
K170818	Craniomaxillofacial Distraction System (CMFD)	Synthes (USA) Products LLC	PBJ	Class II	2017-12-07
K170720	Portex Blue Line Ultra Paediatric Tracheosomy Tube	Abbott Medical	JOH	Class II	2017-12-07
K170046	Lilium a-200E	Lilium Otsuka Co., Ltd.	IYO	Class II	2017-12-07
K173153	Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion System	Nu Vasive, Incorporated	MAX	Class II	2017-12-06
K173091	Boundary Anterior Lumbar Buttress Plate	Nvision Biomedical Technologies, Inc	KWQ	Class II	2017-12-06
K172530	BEAUTIFIL Flow Plus X	Shofu Dental Corp.	EBF	Class II	2017-12-06
K172468	091 Long Sheath, 70 cm, 091 Long Sheath, 80 cm, 091 Long Sheath, 90 cm	Inneuroco, Inc.	DQY	Class II	2017-12-06
K172425	OrthoPediatrics Wrist Fusion Plate	Orthopediatrics Corp	HRS	Class II	2017-12-06
K170934	C3 Wave System	Medical Components, Inc.	LJS	Class II	2017-12-06
K170797	wettrust D2care	Wettrust Korea Co., Ltd.	NUC	Class II	2017-12-06
K173126	Arisstos™ Spinal System	Ingenium Spine	NKB	Class II	2017-12-05
K172993	P20 Series Digital Color Doppler Ultrasound System	Sonoscape Medical Corp.	IYN	Class II	2017-12-05
K172707	Renamel Microfill	Cosmedent, Inc.	EBF	Class II	2017-12-05
K172618	SYSTEMS INTEGRATION ENDOALPHA MEDICAL CONTROL UNIT FOR ENDOSURGERY UCES-4 Software Version 1	Olympus Medical Systems Corp.	GCJ	Class II	2017-12-05
K172561	Disposable Circular Stapler	Changzhou Kangdi Medical Stapler Co., Ltd.	GDW	Class II	2017-12-05
K172529	Vivaer ARC Stylus	Aerin Medical, Inc.	GEI	Class II	2017-12-05
K171447	OxyPure Color Silicone Hydrogel Soft Contact Lenses	Visco Vision Inc.	LPL	Class II	2017-12-05
K173538	Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc	Alcon Laboratories	LRX	Class II	2017-12-04
K173470	ClotTriever Thrombectomy System, ClotTriever Catheter, ClotTriever Sheath	Inari Medical, Inc.	QEW	Class II	2017-12-04
K173260	SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica; SeaSpine Spacer System -Hollywood, Hollywood VI, Ventura, Pacifica; SeaSpine Vu e·POD System	SeaSpine Orthopedics Corporation	MAX	Class II	2017-12-04
K172876	PowerDot PD-01M	Smartmissimo Technologies Pte, Ltd.	NGX	Class II	2017-12-04
K172629	Panther Fusion AdV/hMPV/RV Assay	Hologic, Inc.	OCC	Class II	2017-12-04
K172419	Velofix™ TLIF Cage	CG MedTech Co., Ltd.	MAX	Class II	2017-12-04
K172085	PhotoFix Decellularized Bovine Pericardium	Artivion, Inc.	PSQ	Class II	2017-12-04
K171771	ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay	Siemens Healthcare Diagnostics Inc.	PDJ	Class II	2017-12-04
K173266	Octane aspiration system	Vascular Solutions LLC	QEZ	Class II	2017-12-01
K173209	Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Meropenem/Vaborbactam in the Dilution Range of 0.008/8 - 18/8 ug/mL	Thermo Fisher Scientific Oy	JWY	Class II	2017-12-01
K173148	Acif	Coligne AG	ODP	Class II	2017-12-01
K173129	PRECICE System	NuVasive Specialized Orthopedics, Inc.	HSB	Class II	2017-12-01
K173058	P10 Series Digital Color Doppler Ultrasound System	Sonoscape Medical Corp.	IYN	Class II	2017-12-01
K173038	CuRAS Nd:YAG Laser	Ilooda Co,., Ltd.	GEX	Class II	2017-12-01
K172931	DUS-6000 Digital Ultrasonic Diagnostic Imaging System	Advanced Instrumentations, Inc.	IYO	Class II	2017-12-01