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 838 of 3530

510(k) clearances, page 838 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K130796	Vital Sync Informatics Manager & Virtual Patient Monitoring Platform	Medtronic, Inc.	MWI	Class II	2013-05-09
K130661	Zimmer Trabecular Metal Reverse Shoulder System	Zimmer GmbH	PHX	Class II	2013-05-09
K123710	Unitox Botox Syringe	Bio-Med USA, Inc.	FMF	Class II	2013-05-09
K123581	Nellcor Oximax N-600X Pulse Oximeter, Nellcor Bedside Respiratory Patient Monitoring System, Nellcor Bedside Spo2 Patien	Covidien, Formerly Nellcor Puritan Bennett, Inc.	DQA	Class II	2013-05-09
K122774	Sakura Steam Sterilizaer Model Assv-Ah06; Sakura Steam Sterilizer Model Assv-Ah06e; Skytron Integrity 175; Skytron Integ	Sakura Seiki Co., Ltd.	FLE	Class II	2013-05-09
DEN120022	X-Ray Attenuating Cream	Bloxr Corporation	PDK	Class II	2013-05-09
K130964	Gridlock Plating System	Trilliant Surgical LLC	HRS	Class II	2013-05-08
K130763	Beacon Tissue Marker	Scion Medical Technologies, LLC	NEU	Class II	2013-05-08
K130655	Response Spine System	Orthopediatrics Corp	OSH	Class II	2013-05-08
K130513	Volista 400; Volista 600	Maquet SAS	FTD	Class II	2013-05-08
K123684	Sol-Care Safety Needle	Sol-Millennium Medical, Inc.	FMI	Class II	2013-05-08
K123095	Medline Blood Pressure Transducer	MEDLINE INDUSTRIES, LP - Northfield	DRS	Class II	2013-05-08
K123079	Olympic Brainz Monitor	Excel-Tech Ltd. (Xltek)	OMA	Class II	2013-05-08
K122877	Range Spinal System, Small Stature	K2M, Inc	OSH	Class II	2013-05-08
K131009	Proteus Patch, Ingestible Sensor (Accessory)	Proteus Digital Health, Inc.	OZW	Class II	2013-05-07
K130825	Azure Anterior Cervical Plate System	Orthofix SRL	KWQ	Class II	2013-05-07
K130624	Coni	Globalmed, Inc.	LLZ	Class II	2013-05-07
K130494	Unitron Tinnitus Masker Feature	Unitron Hearing	KLW	Class II	2013-05-07
K130326	Tephaflex Meltblown Construct	Tepha, Inc.	OOD	Class II	2013-05-07
K123748	Abl90 Flex	Radiometer Medical ApS	CHL	Class II	2013-05-07
K123368	Latex Powder Free Examination Gloves with Colloidal Oatmeal Usp Skin Protectant	Hartalega Sdn Bhd	LYY	Class I	2013-05-07
K122923	Quanta Flash Ena7	Inova Diagnostics, Inc.	LLL	Class II	2013-05-07
K122741	Hoveround Teknique	Hoveround Corp.	ITI	Class II	2013-05-07
K122707	Hoverround Teknique	Hoveround Corp.	ITI	Class II	2013-05-07
K122343	Pureflux-H Hemodialyzer	Nipro Medical Corporation	KDI	Class II	2013-05-07
K122064	Forsure One Step Buprenorphine Cup Test Device	Tianjin New Bay Bioresearch Co., Ltd.	DJG	Class II	2013-05-07
K120590	Dilator Tube Set	Koros USA, Inc.	PDQ	Class II	2013-05-07
K130963	Liquichek Pediatric Control, Level 1; Liquichek Pediatric Contol, Level 2; Liquichek Pediatric Control, Bilevel Minipak	Bio-Rad Laboratories Inc.	JJY	Class I	2013-05-06
K124016	Empi Phoenix	DJO, LLC	IPF	Class II	2013-05-06
K122404	Model Number: Rms1-2604, Rms1-2614, Rms1-2404, Rms1-2414, Rms2-2604, Rms2-2614, Rms2-2404, Rms2-2414, Rms3-2604, Rms3-26	Repro-Med Systems, Inc. dba Rms Medical Products	FPA	Class II	2013-05-06
K121702	Orthocor Active Device Orthocor General Use Active Device	Orthocor Medical Inc.	ILX	Class II	2013-05-06
K130786	Sleek Otw Pta Catheter	C.R. Bard Inc	LIT	Class II	2013-05-03
K130632	Sterispine Ps Pedicle Screw	Safe Orthopaedics	NKB	Class II	2013-05-03
K130594	Ensite Velocity System	Abbott Medical	DQK	Class II	2013-05-03
K130458	Knotless Fibertak Suture Anchor	Arthrex GmbH	MBI	Class II	2013-05-03
K130334	Hoffmann Lrf (Limb Reconstruction Frame System)	Stryker Trauma GmbH	KTT	Class II	2013-05-03
K130250	Qyag Laser System	Palomar Medical Technologies, Inc.	GEX	Class II	2013-05-03
K130147	Anatomic Ankle Arthrodesis Interlocking Nail (A3 Interlocking Nail)	Small Bone Innovations, Inc.	HSB	Class II	2013-05-03
K130084	Milestone Revision Knee System (Mrks) - Femoral Component, Tibial Baseplate, Tibial Insert, Stems, Femoral & Tibial Augm	Tgm Medical, Inc.	JWH	Class II	2013-05-03
K123926	Metasurg Nitinol Staple Implant	Metasurg	JDR	Class II	2013-05-03
K123600	Digital Blood Pressure Monitor	Little Doctor Electronic(nantong) Co.,Ltd	DXN	Class II	2013-05-03
K123486	Triathlon Tritanium Tibial Baseplate	Stryker Corp.	MBH	Class II	2013-05-03
K123159	Smith & Newphew, Inc. Disposable Knee Instruments	Smith & Nephew, Inc.	JWH	Class II	2013-05-03
K122721	Ag Guffill	Hospitech Respiration	BSK	Class II	2013-05-03
K122559	Biodenta Dental Implant System - Abutments	Biodenta Swiss AG	NHA	Class II	2013-05-03
K122500	Neo Ps Knee System	Pipeline Orthopedics	JWH	Class II	2013-05-03
K122416	Artiglass L. o.r. Glass Syringe	Artiglass SRL	FMF	Class II	2013-05-03
K121404	Solopath Re-Collapsible Access System	Onset Medical Corporation	DYB	Class II	2013-05-03
K121243	Ultrasonic Biometer for Ophthalmology Ultrasonic Pachymeter	MEDA Co., Ltd.	IYO	Class II	2013-05-03
K120597	Kompreda	Custom Spine, Inc.	MRW	Unclassified	2013-05-03