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 651 of 3529

510(k) clearances, page 651 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K160994	C2 CryoBalloon Focal Pear Catheter	PENTAX of America, Inc.	GEH	Class II	2016-05-19
K160537	Navio	Blue Belt Technologies, Inc.	OLO	Class II	2016-05-19
K160403	SmartStart Air/Water and Suction Valves	Boston Scientific Corporation	ODC	Class II	2016-05-19
K160342	EMPOWR PS Knee System	Encore Medical, LP	JWH	Class II	2016-05-19
K160290	Valleylab REM Polyhesive Infant Patient Return Electrode	Medtronic, Inc.	GEI	Class II	2016-05-19
K153778	Nester Embolization Coils, Tornado Embolization Coils	Cook Incorporated	KRD	Class II	2016-05-19
K153658	Target Detachable Coils	Stryker Corp.	HCG	Class II	2016-05-19
K153264	EasyPass Guidewire	Medi-Globe GmbH	OCY	Class II	2016-05-19
K153107	Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine VEO™ Lateral Access & Interbody Fusion System, Choice Spine Interbody Fusion System	Choicespine, LP	MAX	Class II	2016-05-19
K152842	Wallstent Rp Endoprosthesis Tracheobronchial, Wallstent Endoprosthesis Tracheobronchial	Boston Scientific Corporation	JCT	Class II	2016-05-19
K152466	Neo-Bronchoscope -Digital Video Bronchoscopy System(Rigid/Flexible)	Prosurg, Inc	EOQ	Class II	2016-05-19
K152452	Peacock Tanning, EXPRESS TAN models 1000HT/1600HT/2000CT/2000HT/3200	Medtek Lighting Corp D/B/A Peacock Tanning	LEJ	Class II	2016-05-19
K150553	Filbloc	Assut Europe S.p.A.	NEW	Class II	2016-05-19
K161229	Mammo Tomosynthesis (MDMG-5221)	Barco N.V.	PGY	Class II	2016-05-18
K160332	Stryker SDC3 HD Information Management System with Wireless Device Control Capability	Stryker Corp.	GCJ	Class II	2016-05-18
K160226	JAZZ CLAW System (hooks and rods) and JAZZ CLAW connector	Implanet	NKB	Class II	2016-05-18
K153663	Vario 8/18/ci	Medela AG	BTA	Class II	2016-05-18
K161082	IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone Calibration Verifiers	Immunodiagnostic Systems Ltd.	JJX	Class I	2016-05-17
K161080	Escalade Legend Acetabular Shell	Ortho Development Corp.	LPH	Class II	2016-05-17
K160480	PicoSure Workstation	Cynosure, LLC	GEX	Class II	2016-05-17
K160356	Third Eye Panoramic Auxiliary Endoscopy System - Resposable	Avantis Medical Systems, Inc.	FDF	Class II	2016-05-17
K153716	GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System.	GPC Medical Limited	HRS	Class II	2016-05-17
K153553	SiO2 Coated syringe 3 ml	SIO2 Medical Products, LLC	FMF	Class II	2016-05-17
K153331	SafeCT-29	Medic Vision - Imaging Solutions, Ltd.	JAK	Class II	2016-05-17
K152657	SMART PERFORMER 55 (Ocufilcon D) Soft (hydrophilic) Contact Lens	Smart Performer Corp., Ltd.	LPL	Class II	2016-05-17
K152062	BIOFOAM Bone Wedge	Wrightmedicaltechnologyinc	HRS	Class II	2016-05-17
K160280	MagPro R20	Tonica Elektronik a/S	GWF	Class II	2016-05-16
K160090	Lumipulse G ROMA	Fujirebio Diagnostics, Inc.	ONX	Class II	2016-05-16
K153683	Trak Male Fertility Testing System	Sandstone Diagnostics, Inc.	POV	Class II	2016-05-16
K153396	Aesculap OrthoPilot Next Generation	Aesculap Inc	OLO	Class II	2016-05-16
K152754	Comprehensive Vault Reconstruction System (Vrs)	Biomet Manufacturing Corp	PHX	Class II	2016-05-16
K161119	SonoSite iViz Ultrasound System	FUJIFILM SonoSite,Inc.	IYN	Class II	2016-05-13
K161117	EzDent-i / E2 / Prora View	Ewoosoft Co., Ltd	LLZ	Class II	2016-05-13
K161057	Diagnostic Imaging Color LCD Monitor	Nec Display Solutions, Ltd.	PGY	Class II	2016-05-13
K160710	Oasis Lacrimal Intubation Set	Anodyne	OKS	Unclassified	2016-05-13
K160380	Lt-300 Hd	Lutech Industries	HEX	Class II	2016-05-13
K160240	Perimeter Otis™ 1.0 Optical Coherence Tomography System	Perimeter Medical Imaging, Inc.	NQQ	Class II	2016-05-13
K160154	ALTA Anterior Cervical Interbody Spacer	Astura Medical	ODP	Class II	2016-05-13
K160057	ArcCHECK-MR	Sun Nuclear Corporation	IYE	Class II	2016-05-13
K153563	AirFit F20	ResMed Corp	BZD	Class II	2016-05-13
K153490	DD medical polymers	Dental Direkt GmbH	EBG	Class II	2016-05-13
K153236	Small PerFix Light Plug with 6 x 13.5 cm HydroLight onlay, Medium PerFix Light Plug with 6 x 13.5 cm HydroLight onlay, Large PerFix Light Plug with 6 x 13.5 cm HydroLight onlay, Extra Large PerFix Light Plug with 6 x 13.5 cm HydroLight onlay	C.R. Bard Inc	FTL	Class II	2016-05-13
K153045	SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator	Easy Med Instrument Co., Ltd.	BXN	Class II	2016-05-13
K152510	UltraCor Twirl Breast Tissue Marker	Bard Peripheral Vascular Inc	NEU	Class II	2016-05-13
K152353	SeraQuest HSV Type 2 Specific IgG	Quest International, Inc.	MYF	Class II	2016-05-13
K152068	Astral 100/150	ResMed Corp	CBK	Class II	2016-05-13
K152020	Bindex BI-100	Bone Index Finland Ltd.	MUA	Class II	2016-05-13
DEN140032	Cereve Sleep System	Cereve, Inc.	PLU	Class II	2016-05-13
K161046	Laser Helmet LH40-EVO	Theradome, Inc.	OAP	Class II	2016-05-12
K160419	Monoject Enteral Feeding Syringe with ENFit Connector	Medtronic, Inc.	PNR	Class II	2016-05-12