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 2026-10-15, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,969 of the 176,366 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	2,569

176,366 records, page 385 of 3528

510(k) clearances, page 385 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K200810	IPS CaseDesigner	Nobel Biocare AB	LLZ	Class II	2020-10-08
K200793	LnK Posterior Cervical Fixation System and CastleLoc-S Posterior Cervical Fixation System	L&K Biomed Co.,Ltd.	NKG	Class II	2020-10-08
K200767	SilverStream Gel	Enzysurge, Ltd.	FRO	Unclassified	2020-10-08
K200661	Steripath Micro Blood Collection System	Magnolia Medical Technologies, Inc.	FPA	Class II	2020-10-08
K193542	Clearum HS Family, Clearum HS Models: HS 13, HS 15, HS 17, HS 20, HS 22	BELLCO SRL	KDI	Class II	2020-10-08
K192703	Cranial Image Guided Surgery System, Navigation Software Cranial, Navigation Software ENT, Registration Software Cranial, Automatic Registration 2.0, Ultrasound Navigation Software (BK), Intraoperative Structure Update	Brainlab, Inc.	HAW	Class II	2020-10-08
K202633	ScanX Edge	Durr Dental SE	MUH	Class II	2020-10-07
K202293	Radiographic System Challenge X	Sedecal S.A.	KPR	Class II	2020-10-07
K202119	AcuSee AS-P1000 System	Weipeng (Suzhou) Medical Devices Co., Ltd.	IYO	Class II	2020-10-07
K201453	Fortilink Cages with TiPlus Technology	Paradigm Spine GmbH	MAX	Class II	2020-10-07
K201380	Livocare Surgical Mask	Andon Health Co., Ltd	FXX	Class II	2020-10-07
K200817	URIS OMNI Narrow System & Prosthetic	TruAbutment Inc.	DZE	Class II	2020-10-07
K200802	Infrared Thermometer	Shenzhen Urion Technology Co., Ltd.	FLL	Class II	2020-10-07
K200725	Citregen Tendon Interference Screw and Citrelock	Acuitive Technologies	MAI	Class II	2020-10-07
K200100	Abutment Design	3Shape A/S	PNP	Class II	2020-10-07
K192949	Flower Suture Anchor Set	FLOWER ORTHOPEDICS Corporation dba Conventus Flower	MBI	Class II	2020-10-07
K202584	iSleeve Introducer Set	Boston Scientific Corporation	DYB	Class II	2020-10-06
K202253	TruForm Sievers Annuloplasty Ring	Genesee BioMedical, Inc.	KRH	Class II	2020-10-06
K202114	CoolSeal Generator/CSL-200-50, CoolSeal Trinity (30 cm shaft)/CSL-TR105-30, CoolSeal Trinity (37 cm shaft)/CSL-TR105-37, CoolSeal Trinity (44 cm shaft)/CSL-TR105-44, CoolSeal Mini (20cm shaft)/CSL-MN103-20	Bolder Surgical, LLC	GEI	Class II	2020-10-06
K201701	R3 HA Coated Acetabular Shells	Smith & Nephew, Inc.	MBL	Class II	2020-10-06
K200953	NuVasive® Cohere® Thoracolumbar Interbody System	Nu Vasive, Incorporated	MAX	Class II	2020-10-06
K200728	Pitkar DeftFix System	S.H.Pitkar Orthotools Pvt., Ltd.	KTT	Class II	2020-10-06
K202294	Affirm Contrast Biopsy	Hologic, Inc.	IZH	Class II	2020-10-05
K202292	Ude	Ebm Technologies, Inc.	LLZ	Class II	2020-10-05
K201659	KHEIRON® Spinal Fixation System	S.M.A.I.O	NKB	Class II	2020-10-05
K201561	Membrane Screws and Membrane Tacks	Neoss, Ltd.	DZL	Class II	2020-10-05
K200792	MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides	Medacta Inernational SA	PQC	Class II	2020-10-05
K200217	ClearEndoclip	Finemedix	PKL	Class II	2020-10-05
K200031	Neonatal Phototherapy System	Avalon Biomedical (Shenzhen) Limited	LBI	Class II	2020-10-05
K202557	Quantum Workstation 12 Elite	Spectrum Medical Inc	DRY	Class II	2020-10-02
K202280	Cleerly Labs v2.0	Cleerly, Inc	LLZ	Class II	2020-10-02
K202218	ZelanteDVT THrombectomy System, ZelanteDVT ClotHunter Helical Rotation Device	Boston Scientific Corporation	QEW	Class II	2020-10-02
K202207	Materialise PKA Guide System	Materialise N.V.	HSX	Class II	2020-10-02
K202190	Oculus-SA Lumbar Cage System	Neurostructures, Inc.	OVD	Class II	2020-10-02
K202170	LiverMultiScan	Perspectum Ltd.	LNH	Class II	2020-10-02
K201748	Latex Powder Free Surgical Glove with Protein Labelling Claim of 50 Microgram or Less per Gram of Glove and Tested for use with Chemotherapy Drugs	Hartalega Sdn Bhd	KGO	Class I	2020-10-02
K201559	HAL for Medical Use(Lower Limb type)	Cyberdyne Inc.	PHL	Class II	2020-10-02
K201546	OsOpia Synthetic Bone Void Filler	Revisios BV	LYC	Class II	2020-10-02
K201301	X100 with Full Field Peripheral Blood Smear (PBS) Application	Scopio Labs Ltd.	JOY	Class II	2020-10-02
K201238	Encore System	Siesta Medical, Inc.	ORY	Class II	2020-10-02
K201161	Infrared Thermometer Model E127	Bioland Technology Ltd.	FLL	Class II	2020-10-02
K200682	Bzf-29	GC America Inc.	KLE	Class II	2020-10-02
K200623	OssGuide	Sk Bioland Co., Ltd.	NPL	Class II	2020-10-02
K193410	SOZO Body Fluid Analyzer	Impedimed, Inc.	DSB	Class II	2020-10-02
K191320	Slow Wave DS8	Slow Wave, Inc.	LQZ	Class II	2020-10-02
K190707	Arthrex SoftStitch	Arthrex GmbH	GAT	Class II	2020-10-02
K202357	Nutricare Clear-ISOSAF Nasogastric Feeding Tube	Three Circles Consulting Limited	PIF	Class II	2020-10-01
K201446	HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight Module	Edwards Lifesiences, LLC	DQK	Class II	2020-10-01
K201381	Philips Avent Single/Double electric breast pump Advanced	Philips Consumer Lifestyle - Innovation Site Eindhoven	HGX	Class II	2020-10-01
K201359	ECG Cables and Leadwires	Xinkang Medical Instrument Co. Ltd.	DSA	Class II	2020-10-01