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 2026-10-29, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 840 of 3530

510(k) clearances, page 840 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K130764	Audit Microcv Vitamin D Linearity Set	Aalto Scientific Ltd.	JJX	Class I	2013-04-26
K130201	Nystagram Video Nystagmography System	Ototronix, LLC	GWN	Class II	2013-04-26
K123990	Sentrant Introducer Sheath with Hydrophilic Coating	Medtronic, Inc.	DYB	Class II	2013-04-26
K123921	Bodytronic 200	Bauerfeind AG	JOM	Class II	2013-04-26
K123755	Multi Angled Abutment	OSSTEM Implant Co., Ltd.	NHA	Class II	2013-04-26
K123386	Periotype X-Pert	Clinical House Europe GmbH	DZE	Class II	2013-04-26
K123271	Abbott Phenobarbital Assay	Microgenics Corporation	DLZ	Class II	2013-04-26
K122908	Prg Barrier Coat	Shofu Dental Corp.	LBH	Class II	2013-04-26
K122549	Dento Temp	Itena Clinical	EMA	Class II	2013-04-26
K122510	Icrco 3600M	Icrco, Inc.	MUE	Class II	2013-04-26
K122225	Sterile Radiolucent Skull Pins	Brainlab, Inc.	HBL	Class II	2013-04-26
K120984	Masimo Ras-125C Acoustic Respiration Sensor	Masimo Corporation	DQA	Class II	2013-04-26
K113781	Pantheon Spinal Ibfd System	Pantheon Spinal LLC	MAX	Class II	2013-04-26
K130886	Glooko Device System for Glooko Logbook+ Application	Glooko Inc	NBW	Class II	2013-04-25
K130860	Variant II Hemoglobin A1c Program (New), Variant II Hemoglobin Testing System with Cdm Software, Cdm Software	Bio-Rad Laboratories, Inc., Clinical Systems Divis	LCP	Class II	2013-04-25
K130445	Vault Alif System	Spinal USA	OVD	Class II	2013-04-25
K130030	Zavation Cervical Plate System	Zavation	KWQ	Class II	2013-04-25
K124032	Metaneb	Hill-Rom Services Pte, Ltd.	NHJ	Class II	2013-04-25
K123527	Airlife	Care Fusion	CAF	Class II	2013-04-25
K123282	Deonization Exchange Tanks, Carbon Exchange Tanks	Ultrapure & Industrial Services, LLC	FIP	Class II	2013-04-25
K123128	Seri Surgical Scaffold	Allergan	OXF	Class II	2013-04-25
K123028	Vertessa Lite 10 X20cm, Vertessa Lite 11 X 30Cm, Vertessa Lite Y-Mesh	Caldera Medical, Inc.	OTO	Class II	2013-04-25
K122703	Rapidfret Oral Fluid Assay for Pcp, Pcp Calibrator Set, Pcp Control Set and Rapidease Oral Fluid Collector	Biophor Diagnostics, Inc.	LCM	Unclassified	2013-04-25
K120800	Nvision Vle Imaging System	Ninepoint Medical, Inc.	NQQ	Class II	2013-04-25
K130896	Vascular Probe, Vascular Probe Es	Synovis Life Technologies, Inc.	DWP	Class II	2013-04-24
K123936	Surgiseal Topical Skin Adhesive	Adhezion Biomedical, LLC	MPN	Class II	2013-04-24
K123915	De48-Plus	Grass Technologies, an Astro-Med, Inc. Product Gro	GXY	Class II	2013-04-24
K123658	Biomodule 3-M1	Zephyr Technology Corporation	DRX	Class II	2013-04-24
K123295	Rhythm View	Topera, Inc.	DQK	Class II	2013-04-24
K122826	Preview Forward-Looking Ivus Catheter and Laptop System; Preview Catheter Model 87000; Pimf Model 87-Pimf; Laptop System	Volcano Corporation	DQY	Class II	2013-04-24
K120989	True Metrix Self-Monitoring Blood Glucose System, True Metrix Professional Monitoring Blood Glucose System	Trividia Health, Inc.	NBW	Class II	2013-04-24
K130741	Erchonia Pl5000	Erchonia Medical, Inc.	NHN	Class II	2013-04-23
K130643	Acceledent Aura	Orthoaccel Technologies, Inc.	OYH	Class II	2013-04-23
K130389	Mayfield Infinity Xr2 Skull Clamp	Integra LifeSciences Corporation	HBL	Class II	2013-04-23
K130161	Passeo-35	BIOTRONIK AG	LIT	Class II	2013-04-23
K123973	Aquamax (Polymacon) Disposable Soft (Hydrophilic) Contact Lenses	Pegavision Corporation	LPL	Class II	2013-04-23
K123307	Nuvasive Nvm5 System	NuVasive Inc	PDQ	Class II	2013-04-23
K123018	Ace Alera Clinical Chemistry System, Ace Glucose Reagent, Ace Ion Selective Electrode (Ise) Module	Alfa Wassermann Diagnostic Technologies, Inc.	CFR	Class II	2013-04-23
K122485	Encircle Compression Therapy Stocking	Encircle Medical Devices, Ltd.	DWL	Class II	2013-04-23
K122051	Nxstage System One	NxStage Medical Inc	KDI	Class II	2013-04-23
K130590	Aap Cannulated Screw 2.0	AAP Implantate AG	HWC	Class II	2013-04-22
K130318	Nexus Drf Digital X-Ray Imaging System (with Paxscan 4343Cb)	Varian Medical Systems, X-Ray Products-Infimed	JAA	Class II	2013-04-22
K123539	Stayhealthy Health Kiosk, Stayhealthy Healthcenter Kiosk	Stayhealthy, Inc.	DXN	Class II	2013-04-22
K122381	Nexfin Model 2	Edwards Lifesciences LLC	DXN	Class II	2013-04-22
K122167	Nexxis or	Barco N.V.	DXJ	Class II	2013-04-22
K122146	Xhibit Central Station, Model 96102	GE Healthcare	MHX	Class II	2013-04-22
K123483	Diode Laser	Beijing Syntech Laser Co., Ltd	GEX	Class II	2013-04-21
K120250	Fibrillar Collagen Wound Dressing	Collafirm, LLC	KGN	Unclassified	2013-04-21
K130489	Electrode, Flexible Suction Coagulator	Optim LLC	FEH	Class II	2013-04-19
K130441	Faller Stylet	Medionics International, Inc.	FJS	Class II	2013-04-19