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 2026-11-05, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,132 of the 176,529 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	2,732

176,529 records, page 1244 of 3531

510(k) clearances, page 1244 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K051165	Kls Martin Sternal Talon	KLS-Martin L.P.	HRS	Class II	2006-09-07
K062465	Zyoptix Xp Epi Separator System	Bausch & Lomb Incorporated	HNO	Class I	2006-09-06
K062407	Gateway Thoracolumbar Plate System	Globus Medical, Inc.	KWQ	Class II	2006-09-06
K062392	Philips Mp5 Intellivue Patient Monitor	Philips Medizin Systeme Boeblingen GmbH	MHX	Class II	2006-09-06
K062316	Dimension Vista Ammonia (Amon) Flex Reagent Cartridge	Siemens Healthcare Diagnostics Inc.	JIF	Class I	2006-09-06
K062199	Dimension Vista System Drug 3 Calibrator (Drug 3 Cal - Kc430)	Siemens Healthcare Diagnostics Inc.	DLJ	Class II	2006-09-06
K062067	Textured Power Free Bp2000 (Butadiene Polymer) Exam Gloves, Natural Color	Shen Wei (USA), Inc.	LZA	Class I	2006-09-06
K062059	Aie Region of Interest Image Enhancement	Advanced Image Enhancement, Inc.	LLZ	Class II	2006-09-06
K062042	Plethora Solutions Sexual Assessment Monitor (Sam)	Plethora Solutions	LIL	Unclassified	2006-09-06
K062034	Dimension Vista System Drug 1 Calibrator (Drug 1 Cal - Kc410)	Siemens Healthcare Diagnostics Inc.	JIX	Class II	2006-09-06
K061995	Xcelera	Philips North America LLC	LLZ	Class II	2006-09-06
K061961	Art Lab Software	Pie Medical	LLZ	Class II	2006-09-06
K061884	Bovie Icon Gi Electrosurgical Generator, Model Gi 120	Apyx Medical Corporation	GEI	Class II	2006-09-06
K061825	Dimension Vista Crp Flex Reagent Cartridge, Protein 2 Calibrator, Control Low and Control High	Siemens Healthcare Diagnostics Inc.	DCN	Class II	2006-09-06
K061764	Medibyte, Model Mp8	Braebon Medical Corp.	MNR	Class II	2006-09-06
K061742	Uryxxon Relax Urine Analyzer	Macherey Nagel GmbH & Co. KG	JIL	Class II	2006-09-06
K061731	Medgraphics Ultima System	Medical Graphics Corp.	BZL	Class II	2006-09-06
K061663	Endomedical Technologies Quik-Cover Flexible Endoscope Barrier Sheath for Otolaryngoscopes and Bronchoscopes	Rtc Inc.-Memcath Technologies, LLC	EOB	Class II	2006-09-06
K061394	Specialty Needles (Spinal Needle, Pencil Point Spinal Needle, Epidural Needle)	Busse Hospital Disposables	BSP	Class II	2006-09-06
K060765	Hemocue Glucose 201 Rt Analyzer Mdl 120731, Hemocue Glucose 201 Rt Microcurettes Mdl 110712	HemoCue AB	LFR	Class II	2006-09-06
K060623	Shortshot Saeed Hemorrhoidal Multi-Band Ligator with Triview Anoscope	Cook Ireland Ltd.	FER	Class II	2006-09-06
K060180	Bioset Xc	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)	MBP	Class II	2006-09-06
K053540	Intermedic Diode Laser Family 810Nm and 980Nm (and the Delivery Accessories That Are Used with Them to Deliver Laser Ene	Intermedic Arfran, S.A.	GEX	Class II	2006-09-06
K053418	Synthes Oc Fusion System	Synthes Spine Co.Lp	KWP	Class II	2006-09-06
K062504	Ceramax	Alphadent Co., Ltd.	EIH	Class II	2006-09-05
K062281	Zimmer One-Piece Implant, 4.7Mm, Straight, Models Zop47s10, Zop47s11, Zop47s13, Zop47s16	ZimVie US Corp LLC	DZE	Class II	2006-09-05
K062159	Rb12 Suction Rectal Biopsy System	Aus Systems Pty Ltd.	FCK	Class II	2006-09-05
K062020	Lifesound Esophageal Stethoscope	Novamed Co., Ltd.	BZT	Class II	2006-09-05
K061960	Fore-Sight Cerebral Oximeter Monitor, Model 2040	Cas Medical Systems, Inc.	MUD	Class II	2006-09-05
K061958	Medtronic Export Xt Catheter	Medtronic, Inc.	QEZ	Class II	2006-09-05
K061928	Coronis Color 2Mp and Mdcc 2121	Barco N.V.	LLZ	Class II	2006-09-05
K061927	Coronis Color 3Mp and Mdcc 3120-Dl	Barco N.V.	LLZ	Class II	2006-09-05
K061924	Coronis 3Mp and Mdcg 3120-Cb	Barco N.V.	LLZ	Class II	2006-09-05
K061874	Invacare's Twilight II Nasal Masks	Invacare GmbH	BZD	Class II	2006-09-05
K061781	Multilink Sprint	Ivoclar Vivadent, Inc.	EMA	Class II	2006-09-05
K061759	Reprocessed External Fixation Device	Stryker Sustainability Solutions	KTT	Class II	2006-09-05
K061635	Msd Bipolar Forceps	Medtronic Sofamor Danek	GEI	Class II	2006-09-05
K061442	Pulse Oximeter, Model Pm-50	Shenzhen Mindray Bio-Medical Electronics Co.,LTD	DQA	Class II	2006-09-05
K061364	Pilot Posterior Lumbar Plating System	Life Spine	MNH	Class II	2006-09-05
K061224	Lapdoc I	Robodent GmbH	HAW	Class II	2006-09-05
K060948	Portrait Psr3	Rhytec Incorporated	GEI	Class II	2006-09-05
K060734	Fresenius Com.tec Automated Cell Separator, Model 9008031; Fresenius C5l, S5l, C5l-T Platelet Sets (5-Day Storage)	Fresenius Medical Care Renal Therapies Group, LLC	LKN	Unclassified	2006-09-05
K052532	Imax 9.5 Sterilizers	Dental X SRL	FLE	Class II	2006-09-05
K052492	Airnergy+stream	Natural Energy Solutions AG	ILY	Class II	2006-09-05
K062431	Hemosil Liquid Antithrombin	Instrumentation Laboratory Co.	JBQ	Class II	2006-09-01
K062430	Hemosil Protein C	Instrumentation Laboratory Co.	GGP	Class II	2006-09-01
K062393	Ge Vantage Pet Neuro Software	GE Healthcare	KPS	Class II	2006-09-01
K062326	Autosuture Modified Versaport Trocar with Fixation Sleeve	United States Surgical, A Division of Tyco Healthc	GCJ	Class II	2006-09-01
K062317	Modification to Nuvasive Spherx II System	NuVasive Inc	MNH	Class II	2006-09-01
K062307	Xclose Tissue Repair System, Model Srs	Anulex Technologies, Inc.	GAT	Class II	2006-09-01