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 2026-10-19, 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 506 of 3529

510(k) clearances, page 506 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K181702	Tranquil-L Interbody System	Nexus Spine, L.L.C.	MAX	Class II	2018-09-21
K181665	BD Phoenix Automated Microbiology System - BD Phoenix CPO detect - GN	Becton Dickinson & Co	LON	Class II	2018-09-21
K181616	PSM 3-Way Silicone Foley Catheter	Pathway, LLC	EZL	Class II	2018-09-21
K181200	AEROmini Tracheobronchial Stent System	Merit Medical Systems, Inc.	JCT	Class II	2018-09-21
K181034	Pocket Colposcope System	Hadleigh Health Technologies	HEX	Class II	2018-09-21
K181006	BB-613 Watch Oximeter	Bio-Beat Technologies, Ltd.	DQA	Class II	2018-09-21
K180489	TEVADAPTOR Closed Drug Reconstitution and Transfer System	Teva Medical Ltd., Migada Plant	ONB	Class II	2018-09-21
K180338	Cellulize	Ward Photonics, LLC	OLI	Class II	2018-09-21
K180144	Agile Esophageal Stent System	Boston Scientific Corporation	ESW	Class II	2018-09-21
K180029	Malecot Nephrostomy Catheter/Stent Set	Cook Incorporated	FAD	Class II	2018-09-21
K173960	DePuy Corail AMT Hip Prosthesis	Depuy France S.A.S.	LZO	Class II	2018-09-21
K172418	OpenSight	Novarad Corp.	LLZ	Class II	2018-09-21
K171947	Soloassist II	AKTORmed GmbH	NAY	Class II	2018-09-21
DEN070001	Non-Variola Orthopoxvirus Real-Time PCR Primer and Probe Set	Centers for Disease Control and Prevention	PBK	Class II	2018-09-21
K182340	NICO Myriad	Nico Corporation	GEI	Class II	2018-09-20
K181995	Chiral Surgical Pedicle Screw System	Chiral Surgical	NKB	Class II	2018-09-20
K181783	Logiq P9; Logiq P7	GE Healthcare	IYN	Class II	2018-09-20
K181726	Medline Patient Cables and Lead Wires	MEDLINE INDUSTRIES, LP - Northfield	DSA	Class II	2018-09-20
K181420	Aequalis Flex Revive Shoulder System	TORNIER Inc.	KWS	Class II	2018-09-20
K181305	OralTox Oral fluid Drug Test	Premier Biotech, LLC	DJC	Class II	2018-09-20
K181205	Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set	Centers for Disease Control and Prevention	PBK	Class II	2018-09-20
K181199	Katalyst Mark 1 Muscle Stimulation System Model 2	Katalyst, Inc.	NGX	Class II	2018-09-20
K180366	EndoTool SubQ	Al Pacheco and Associates	NDC	Class II	2018-09-20
K173898	MicroPort Orthopedics Total Hip Systems MR Labeling	Microport Orthopedics Inc. (Mpo)	LZO	Class II	2018-09-20
K182286	Oh'Care Lite Smart Blood Glucose Monitoring System	OSANG Healthcare CO., Ltd.	NBW	Class II	2018-09-19
K182080	Scope Antifogging System	Xodus Medical Inc	GCJ	Class II	2018-09-19
K181734	Beurer IPL 8500 device/ IPL VelvetSkin Pro	Home Well Trading, Ltd.	OHT	Class II	2018-09-19
K181449	Ortoma Treatment Solution - OTS	Ortoma AB	OLO	Class II	2018-09-19
K181349	Vexillum (olifilcon B) with Tangible Polymers Silicone Hydrogel Soft Contact Lens; Daily Breeze (olifilcon B) Silicone Hydrogel Soft Contact Lens	Visco Vision Inc.	LPL	Class II	2018-09-19
K181328	T2 STRATOSPHERE™ Expandable Corpectomy System	Medtronic Sofamor Danek USA Inc	MQP	Class II	2018-09-19
K181229	TirboLOX-C Cervical IBFD	CAPTIVA SPINE, Inc.	ODP	Class II	2018-09-19
K180981	Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit	Stimwave Technologies Incorporated	GZB	Class II	2018-09-19
K180894	Magnetic Surgical System	Levita Magnetics International Corp.	PNL	Class II	2018-09-19
K180893	IHM Technology Bandage	Protege Biomedical	QSY	Unclassified	2018-09-19
K180781	Bard Vertus Foley Catheter	C.R. Bard Inc	EZL	Class II	2018-09-19
K173982	FORTIFY Corpectomy Spacers	Globus Medical, Inc.	MQP	Class II	2018-09-19
K173141	CSM Submerged3-L Implant System	CSM Implant	DZE	Class II	2018-09-19
K182243	The CVC WAND Safety Introducer with Valved Peelable Sheath	Access Scientific, Inc.	DYB	Class II	2018-09-18
K182157	BioSign Flu A+B	Princeton BioMeditech Corp.	PSZ	Class II	2018-09-18
K181653	Ethicon Circular Stapler, Ethicon Circular Stapler -XL Sealed	Ethicon Endo-Surgery Inc	GDW	Class II	2018-09-18
K181620	Endoscopic Linear Cutting Staplers and Loading Units for Single Use	Ezisurg (Suzhou) Medical Co., Ltd.	GDW	Class II	2018-09-18
K181390	Response Spine System, Response 5.5/6.0 Spine System, Response 4.5/5.0 Spine System	Orthopediatrics Corp	NKB	Class II	2018-09-18
K181337	Sypher Spacer System	Biogennix, LLC	MAX	Class II	2018-09-18
K181320	Caprolon	RESORBA Medical GmbH	GAM	Class II	2018-09-18
K181233	Elecsys FT4 III	Roche Diagnostics GmbH	CEC	Class II	2018-09-18
K173830	MAC VU360 Resting ECG Analysis System	GE Medical Systems Information Technologies, Inc.	DPS	Class II	2018-09-18
K171904	Tandry Locking Plate System	Microware Precision Co., Ltd.	HRS	Class II	2018-09-18
K182260	Palacos Mv	Heraeus Medical GmbH	LOD	Class II	2018-09-17
K181721	Ceracell Ortho Foam	Curasan AG	MQV	Class II	2018-09-17
K181632	Venacure 1470 Pro	Quanta System Inc.	GEX	Class II	2018-09-17