510(k) Report

FDA Device Review Tracker

September 2026

FDA cleared 317 510(k)s, granted 2 De Novo requests and approved 4 original PMAs in September 2026; the median 510(k) took 141 days from receipt. FDA posted 4 Class I recall events.

The month in numbers

510(k) clearances

317

up 23% on a year earlier

De Novo grants

2

down 33% on a year earlier

Original PMA approvals

4

same as a year earlier

Median 510(k) review

141days

Prior 12 months: 129 days

303 of the month’s decisions name a predicate we could read; 38 have a Class I recall somewhere in their family tree.

New device types (De Novo)

  • DEN260007SmartRead (TM) Medical Device Identifier (4100)BridgeSource Medical Corporation · 2026Sep 29, 2026
  • DEN250044Queen of Hearts (ACS AI ECG Model)Powerful Medical, Inc. · 2026Sep 3, 2026

The predicates cited most this month

  • K190660G7 Acetabular System Longevity Highly Crosslinked Polyethylene, G7 Acetabular System Vivacit-E Vitamin E…Zimmer, Inc. · 20192this month
  • K152740Radifocus GlidewireAshitaka Factory of Terumo Corp. · 20152this month
  • K213402Triever24, Triever20Inari Medical · 20222this month
  • K250370SCENARIA View Phase 5.0Fujifilm Corporation · 20252this month
  • K231403evoDrill Cranial PerforatorEvonos GmbH & Co. KG · 20242this month

The deepest new lineages

  • K263182EVO X30 Diagnostic Ultrasound System; EVO X20 Diagnostic Ultrasound System; EVO X10 Diagnostic Ultrasound…Samsung Medison Co., Ltd. · 202639generations
  • K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 202634generations
  • K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc. · 202632generations
  • K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc. · 202629generations
  • K261313Vivid Explorer/Vivid Advanced/Vivid FocusGE Medical Systems Ultrasound and Primary Care Diagnostics · 202628generations

Busiest product codes

  • GEXPowered Laser Surgical Instrument11decisions
  • QIHAutomated Radiological Image Processing Software9decisions
  • LLZSystem, Image Processing, Radiological7decisions
  • NKBThoracolumbosacral Pedicle Screw System7decisions
  • JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer6decisions
  • GEIElectrosurgical, Cutting & Coagulation & Accessories5decisions

Class I recall events (4)

  • K242519Philips Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC · Sep 24, 2026 · Device DesignClass I
  • K162877V+Pro Model Number: PRT-01185-000, Package PN:PRT-01198-000; Model Number…Ventec Life Systems, Inc. · Sep 17, 2026 · 12 products · Under Investigation by firmClass I
  • K170854HemoslL AcuStar HIT-lgG (PF-4). Part Number: 0009802028. in vitro diagnostic (OUS only)Instrumentation Laboratory · Sep 3, 2026 · 2 products · Under Investigation by firmClass I
  • K092029VentStar Resus Neo. Neonatal. 25 Units per Box. Part Number: MP00310 Disposable…Draeger, Inc. · Sep 3, 2026 · Under Investigation by firmClass I