510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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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 , 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
YearClearances
20123,135
20133,052
20143,202
20153,020
20162,956
20173,200
20183,062
20192,918
20202,923
20213,023
20223,209
20233,346
20243,129
20253,225
20262,569
176,366 records, page 204 of 3528
510(k) clearances, page 204 of 3528
K numberDeviceApplicantProduct codeClassDecision date
K223468Nexis® compressive screwsNovastepHWCClass II
K223367Ochsner Connected Inhaler SensorOchsner Clinic FoundationCAFClass II
K223303Spinery™ RF Ablation SystemAxon Spine Medical SystemGEIClass II
K223130Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™ Cuff, Non DEHP (86125, 86130, 86135, 86140, 86145, 86150, 86155, 86160)Medtronic, Inc.BTRClass II
K213418MONTAGE Settable, Resorbable Hemostatic Bone PuttyOrthocon, Inc.MTJUnclassified
K232313LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420); LIGACLIP Endoscopic Rotating Multiple Clip Applier 10mm M/L (ER320)Ethicon Endo-Surgery IncFZPClass II
K232226ARROW Off-Centred Humeral InsertFH IndustriePHXClass II
K231407StarFinPremium Medical Technology, LLCHIFClass II
K230765Precice Ankle Salvage SystemNuVasive Specialized Orthopedics, Inc.HSBClass II
K221361circul™ pro RingBodimetrics, LLCDQAClass II
K232387Treace Medical Concepts (TMC) Compression Implant SystemTreace Medical Concepts, Inc.JDRClass II
K231676CALLISTO eyeCarl Zeiss Meditec IncNFJClass II
K231623Distal Elbow Plating SystemSkeletal Dynamics, IncHRSClass II
K231537SofWave SystemSofwave Medical Ltd.OHVClass II
K231435KIMTECH™ Polaris™ Xtra Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric AcidKimberly-Clark CorporationLZAClass I
K231422Precision GILimaca Medical LtdFCGClass II
K230221QDOSE® Multi-purpose Voxel Dosimetry (Personalized Dosimetry in Molecular Radiotherapy)Versant Medical Physics and Radiation SafetyIYXClass I
K230159SoundBite® Crossing System XS PeripheralSoundbite Medical Solutions, Inc.PDUClass II
K223639VisAble.IOTechsomedQTZClass II
K222525Alveoair Digital SpirometerRoundworks Technologies Private LimitedBZGClass II
K232214OMNI Surgical SystemSight Sciences, Inc.MRHClass II
K231994Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Sulbactam-durlobactam in the dilution range of 0.015/4-32/4 ug/mLThermo Fisher Scientific OyJWYClass II
K231903Montage-QS Settable, Resorbable Bone PuttyOrthocon, Inc.MQVClass II
K231872Polaris Bipolar Electrosurgical Generator (29-1000); Polaris Irrigation Module (29-1600); Polaris Light Source Module (29-1900); Dual Footswitch (29-1020)Kirwan Surgical Products, LLCGEIClass II
K231255NovoFine® PlusNovo Nordisk a/SFMIClass II
K231183Non absorbable Surgical Polyester SutureShandong Haidike Medical Products Co., LtdGATClass II
K230928Vein360 Reprocessed Visions PV.018 Digital IVUS CatheterVein 360, LLCOWQClass II
K230566Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic Digital Blood Pressure MonitorJoytech Healthcare Co., Ltd.DXNClass II
K230409Wrist Type Blood Pressure Monitor (W05,W1101L)Shenzhen Jamr Technology Co., LtdDXNClass II
K230364VitalFlow™ ConsoleMichigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.)QNRClass II
K230165Luja Coudé (20118 Male CH8 - small packaging (Pocket size)), Luja Coudé (20111 Male CH10 - small packaging (Pocket size)), Luja Coudé (20112 Male CH12 - small packaging (Pocket size)), Luja Coudé (20114 Male CH14 - small packaging (Pocket size)), Luja Coudé (20101 Male CH10 - large packaging), Luja Coudé (20102 Male CH12 - large packaging), Luja Coudé (20104 Male CH14 - large packaging), Luja Coudé (20106 Male CH16 - large packaging)MEDLINE INDUSTRIES, LP - NorthfieldEZDClass II
K230094Responsive Arthroscopy Stealth and Mini Stealth All-Suture AnchorsResponsive ArthroscopyMBIClass II
K230014MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOptionTonica Elektronik a/SQPLClass II
K223898VitalFlowTM Centrifugal PumpMichigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.)QNRClass II
K223807Reusable Temperature Probe, Disposable Temperature ProbeShenzhen Sino-K Medical Technology Co., Ltd.FLLClass II
K223727LavieenWONTECH Co., Ltd.GEXClass II
K223600Sterilization WrapWuhan Zonsen Medical Products Co., LtdFRGClass II
K223180AIRAscoreAiramed GmbHLLZClass II
K222972BioProtect Balloon Implant™ SystemBioprotect Ltd.OVBClass II
K222786072 Aspiration SystemQ'apel Medical, Inc.NRYClass II
K213670BD Vacutainer K2EDTA Blood Collection Tubes, BD Vacutainer K3EDTA Blood Collection TubesBecton Dickinson & CoGIMClass II
K232291Essenz HLM, Essenz ILBMLivaNova Deutschland GmbHDTQClass II
K232218Zenius™ Spinal SystemMedyssey USANKBClass II
K232215Quantra Hemostasis AnalyzerHemosonics, LLCQFRClass II
K231944CATAMARAN SI Joint Fusion SystemTenon Medical, Inc.OURClass II
K231680AccelFix Lumbar Expandable Cage SystemL&K Biomed Co.,Ltd.MAXClass II
K231604Instrument CaseCochlear AmericasKCTClass II
K231599Stryker MP, Mandible, HMMF and MMF AXS ScrewsStryker Leibinger GmbH & Co. KGDZLClass II
K231557ZENEX FreeMilling & CCM Cast AbutmentIzenimplant Co., Ltd.NHAClass II
K231506Current Health SystemCurrent Health IncMSXClass II