510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK 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
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
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
20262,732
176,529 records, page 1947 of 3531
510(k) clearances, page 1947 of 3531
K numberDeviceApplicantProduct codeClassDecision date
K963614Monotube Carbon TubeHowmedica Corp.JECClass II
K963494Morrison Medical Disposable Restraint StrapMorrison Medical ProductsFMQClass I
K963435Economy Safety Vest Restraint, Shoulder Tie Safety Vest/safety Vest Restraint, Heavy Duty Vest Restraint, Mesh Safety VeZimmer Patient Care DivisionFMQClass I
K963433Threaded Fixation PinOrthopaedic Biosystems, Ltd.JDWClass II
K963431Polyester Pil Wrist/ankle Restraint/wrist Restraint Universal/soft Flannel Wrist/ankle Restraint/foam Limb HolderZimmer GmbHFMQClass I
K963416Ankle Restraint SystemMorrison Medical ProductsFMQClass I
K963399Morrison Medical Stretcher/cot and Backboard RestraintsMorrison Medical ProductsFMQClass I
K963298First Aid Kit(s)Vector Corporation, LLCBYGClass I
K963138Spider StrapBdm Medical, Inc.FMQClass I
K963117P.f.c. Cruciate Retaing Knee SystemJohnson & Johnson Professionals, Inc.JWHClass II
K963089Truzone Peak Flow MeterMonaghan Medical Corp.BZHClass II
K962511Mitek Micro AnchorMitek ProductsMBIClass II
K961891Wlp Single-Segment Version Wlp Solo VIIWright Linear Pump, Inc.JOWClass II
K961797Wlp Gradient Sequential Version/wlp Prolite/wlp Wlp-II LiteWright Linear Pump, Inc.JOWClass II
K961292Wlp Sequential Version Model Wlp Solo VI, Wlp Solo SequentialWright Linear Pump, Inc.JOWClass II
K961062Flexsure ObtSmithkline Diagnostics, Inc.KHEClass II
K964140Gluma ConditionerKulzer GmbHKLEClass II
K964051Needle, AcupunctureS-Tcm Enterprises, Inc.MQXClass II
K964000Bisfil 2BBisco, Inc.KLEClass II
K963815Reusable Trocar with Sleeve (Common)Pilling Weck GroupGCJClass II
K963401Tps Apical ImplantSteri-Oss, Inc.DZEClass II
K963229Sharplan Models 20C, 30C, and 40C CO2 LasersSharplan Lasers, Inc.GEXClass II
K963121Fixture Mount KitSteri-Oss, Inc.DZEClass II
K962559Acs Cortisol ImmunoassayCiba Corning Diagnostics Corp.JFTClass II
K962113Anthos Phacts Version Microplate ReaderColumbia Bioscience, Inc.JJQClass I
K962089Dermamend GelDermarx Corp.MGQUnclassified
K960287Handpiece for Nidek Cv-12000 Phaco SystemNidek, Inc.HQCClass II
K960267Tbm SpongeBiocoll Laboratories, Inc.LYCClass II
K950853Optional Display and Software for Drager VentilatorsDrager, Inc.CBKClass II
K964115Resound Cc4 Personal Hearing SystemResound Corp.ESDClass I
K963901Electrosurgical ProbeSmith & Nephew Endoscopy, Inc.GEIClass II
K963402Innovasive 2.8Mm Roc Suture Bone Fastener and 3.5Mm Roc Suture Bone FastenerInnovasive Devices, Inc.MBIClass II
K963187Modified Labeling of Cardiac Assist Intra-Aortic Balloon Catheters: Model 930 - 940, 30 - 40 Cc Sensation and Nicath 30CBoston Scientific CorporationDSPClass II
K963095Trupeak Peak Flow MeterMonaghan Medical Corp.BZHClass II
K963061Immage Immunochemistry System C-Reactive Protein (Crp) ReagentBeckman Instruments, Inc.DCKClass II
K963060Heelbo Security BeltHeelbo, Inc.FMQClass I
K963048Immage System Rheumatoid Factor (RF) ReagentBeckman Instruments, Inc.DHRClass II
K962987Ez-Fix Small Cannulated Screw SystemBiodynamic Technologies, Inc.HWCClass II
K962690E2590 - B, Argon Accessory with Blade Electrode and E2590 - N, Argon Accessory with Needle ElectrodeMedtronic, Inc.GEIClass II
K962668Amr-Acv ClampsApplied Medical Resources CorpDXCClass II
K962633Vega Hematology AnalyzerAbx, Inc.GKZClass II
K962584Ultracision 5Mm Hard Sheath Laparosonic BladeEthicon Endo-Surgery IncLFLUnclassified
K961895Flexilog Ls 13921Oakfield Instruments, Ltd.KLAClass II
K961668Microferret CatheterCook Inc.KRAClass II
K955854Lifepak 500Physio Control, Inc.MKJClass III
K955276Booster Lite 4 Motorized ScooterOptimed Technologies, Inc.INIClass II
K955275Booster Trophy 5 Motorized ScooterOptimed Technologies, Inc.INIClass II
K955274Booster Lite 3 Motorized ScooterOptimed Technologies, Inc.INIClass II
K955122Intermedics Model 436-07 Bipolar & Model 437-07 Unipolar Implantable Endocardial Pacing LeadIntermedics, Inc.DTBClass III
K964053Hemocue GlucotrolDirect SolutionsJJXClass I