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 488 of 3529

510(k) clearances, page 488 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K182210	TiWAVE-L Porous Titanium Lumbar Cage	Kalitec Medical, LLC	MAX	Class II	2019-01-07
K182114	FlareHawk Interbody Fusion System	Integrity Implants, Inc.	MAX	Class II	2019-01-07
K180564	Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases	Medentika GmbH	NHA	Class II	2019-01-07
K183392	PicoLO Nd:YAG Picosecond Laser System	Laseroptek	GEX	Class II	2019-01-04
K183295	Celerity HP Chemical Indicator (CI)	Steris Corporations	JOJ	Class II	2019-01-04
K183293	VERIFY VH202 Indicator Tape	STERIS Corporation	JOJ	Class II	2019-01-04
K183256	GlideScope BFlex Single-Use Bronchoscope System	Verathon Medical (Canada) ULC	EOQ	Class II	2019-01-04
K183175	BostonSight Scleral	Bostonsight	HQD	Class II	2019-01-04
K183033	Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Omadacycline in the dilution range of 0.03-32ug/ml	Thermo Fisher Scientific Oy	JWY	Class II	2019-01-04
K182982	BridalVeil Navigated Instruments	Astura Medical	OLO	Class II	2019-01-04
K182675	Polygon Resection Device	Polygon Medical, Inc.	HIH	Class II	2019-01-04
K182621	CrossFT Knotless Deep Thread Suture Anchor with Disposable Driver	ConMed Corporation	MBI	Class II	2019-01-04
K181461	Rapid-i™ Kit	Vitrolife Sweden AB	MQK	Class II	2019-01-04
K181053	Care Orchestrator	Respironics, Inc.	BZD	Class II	2019-01-04
K180477	Straumann PURE Ceramic Implant System	Straumann USA, LLC	DZE	Class II	2019-01-04
K180199	Bio-C Temp	Angelus Industria de Produtos Odontologicos S/A	KIF	Class II	2019-01-04
K183643	Clear Image Aligners	Specialty Appliances, LLC	NXC	Class II	2019-01-03
K183301	PRO-LITE Sterilization Tray	STERIS Corporation	KCT	Class II	2019-01-03
K183300	VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack	Steris Corporations	FRC	Class II	2019-01-03
K183297	Vis-U-All Low Temperature Sterilization Pouch/Tubing	STERIS Corporation	FRG	Class II	2019-01-03
K183294	CELERITY 20 HP Biological Indicator, CELERITY HP Challenge Pack	STERIS Corporation	FRC	Class II	2019-01-03
K183214	Raven Lumbar Plate System	Choicespine, LP	KWQ	Class II	2019-01-03
K183143	uCT 520, uCT 528	Shangai United Imaging Healthcare Co., Ltd.	JAK	Class II	2019-01-03
K182766	Cufitec Surgical Mask	Nbc Meshtec, Inc.	OUK	Class II	2019-01-03
K182741	SculpSure	Cynosure, LLC	PKT	Class II	2019-01-03
K182568	V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System	STERIS Corporation	MLR	Class II	2019-01-03
K181127	EndoRotor Console, EndoRotor Catheters, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Foot Control	Interscope, Inc.	PTE	Class II	2019-01-03
K180984	Maxcon Sharps Container	Ningbo Maxcon Medical Technology Co., Ltd	MMK	Class II	2019-01-03
K180983	Maxcon Two Gallon Chemotherapy Container	Ningbo Maxcon Medical Technology Co., Ltd	MMK	Class II	2019-01-03
K180951	Responsive Arthroscopy Suture Anchor System	Responsive Arthroscopy	MBI	Class II	2019-01-03
K180435	Arm Blood Pressure Monitor	Alicn Medical Shenzhen, Inc	DXN	Class II	2019-01-03
K180139	Safe Secure Sterilization Pouches and Rolls	Safe Secure Packing Co., Ltd.	FRG	Class II	2019-01-03
K183542	Signature Orthodontic System	Signature Orthodontics	NJM	Class II	2019-01-02
K183476	3M Filtek Universal Restorative	3M ESPE Dental Products	EBF	Class II	2019-01-02
K183352	Optimus Neuro System	Osteonic Co., Ltd.	GWO	Class II	2019-01-02
K182855	ProKnow DS	Proknow, LLC	LLZ	Class II	2019-01-02
K182199	NFC-700 non-mydriatic auto fundus camera	Crystalvue Medical Corporation	HKI	Class II	2019-01-02
K182025	ClearUP Sinus Pain Relief	Tivic Health Systems, Inc.	GZJ	Class II	2019-01-02
K181864	Polaris RF Ablation System	Baylis Medical Co., Inc.	GXD	Class II	2019-01-02
K181737	Raycell MK1	Best Theratronics Ltd.	MOT	Unclassified	2019-01-02
K181215	Infrared Thermometer	Shenzhen Finicare Co., Ltd.	FLL	Class II	2019-01-02
K183101	Zenition 50	Philips Medical Systems Nederland B.V.	OWB	Class II	2018-12-31
K183000	ViperCath XC Peripheral Exchange Catheter	Cardiovascular Systems Incorporated	DQY	Class II	2018-12-29
K183369	Cor12 ECG	Corscience GmbH & Co.	DPS	Class II	2018-12-28
K182736	OIC Suture Anchor System	The Orthopaedic Implant Company	MBI	Class II	2018-12-28
K181703	Straumann BLX Line Extension - Implants, SRAs and Anatomic Abutments	Straumann USA, LLC	DZE	Class II	2018-12-28
K180867	AmCAD-UO	Amcad Biomed Corporation	LLZ	Class II	2018-12-28
K180204	CranioMaxillofacial Fixation (CMF) System - CMF Visionare	Visionare LLC	JEY	Class II	2018-12-28
DEN170091	EyeBOX	Oculogica Inc.	QEA	Class II	2018-12-28
K183169	Pulse 2.0, Pulse Pro 2.0	Normatec Industries, LP	IRP	Class II	2018-12-27