510(k) Report

FDA Device Review Tracker

April 2026

FDA cleared 314 510(k)s, granted 3 De Novo requests and approved 1 original PMA in April 2026; the median 510(k) took 133 days from receipt. FDA posted 9 Class I recall events.

The month in numbers

510(k) clearances

314

up 11% on a year earlier

De Novo grants

3

down 25% on a year earlier

Original PMA approvals

1

down 67% on a year earlier

Median 510(k) review

133days

Prior 12 months: 126 days

301 of the month’s decisions name a predicate we could read; 53 have a Class I recall somewhere in their family tree.

New device types (De Novo)

  • DEN250023Aurie SystemCathbuddy, Inc. · 2026Apr 30, 2026
  • DEN250033XplantR Explant ToolHjarta Care, LLC · 2026Apr 17, 2026
  • DEN240071neuropacsAutomated Imaging Diagnostics, LLC · 2026Apr 3, 2026

The predicates cited most this month

  • K241322Electric Breast Pump (LD-208L, LD-3010L, LD-2010L, LD-3010, LD-2010)Joytech Healthcare Co., Ltd. · 20243this month
  • K223494CD Horizon Spinal SystemMedtronic · 20233this month
  • K052925SMARTPREP2 Centrifuge SystemHarvest Technologies, Corp. · 20062this month
  • K221784Single-use Video Pancreaticobiliary Scope, PB Digital ControllerMicro-Tech (Nanjing) Co., Ltd. · 20232this month
  • K193373Comprehensive® Reverse ShoulderBiomet, Inc. · 20202this month

The deepest new lineages

  • K252250Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model C, US (2601065)…Shanghai Draeger Medical Instrument Co., Ltd. · 202635generations
  • K254274ARx® SAI Implant SystemLife Spine, Inc. · 202633generations
  • K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc. · 202632generations
  • K250349Vista CMSShanghai Draeger Medical Instrument Co., Ltd. · 202632generations
  • K253401SCRIPT™ Implant SystemGlobus Medical, Inc. · 202632generations

Busiest product codes

  • QIHAutomated Radiological Image Processing Software10decisions
  • HGXPump, Breast, Powered8decisions
  • DYBIntroducer, Catheter7decisions
  • HRSPlate, Fixation, Bone6decisions
  • DXNSystem, Measurement, Blood-Pressure, Non-Invasive5decisions
  • GEIElectrosurgical, Cutting & Coagulation & Accessories5decisions

Class I recall events (9)

  • Z-2797-2026Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle…AVID Medical, Inc. · Apr 30, 2026 · 3 products · Under Investigation by firmClass I
  • Z-2254-2026BDSpinal Tray with BDWhitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 2 mL…Becton Dickinson & Company · Apr 27, 2026 · 10 products · Nonconforming Material/ComponentClass I
  • P200045RelayPro Thoracic Stent-Graft System (various sizes) Reference numbers: 28-N4-32-104-32U…Bolton Medical Inc. · Apr 22, 2026 · Under Investigation by firmClass I
  • K140110Description/REF: EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05502-VM1; EPIDURAL…Arrow International, LLC · Apr 21, 2026 · 35 products · Nonconforming Material/ComponentClass I
  • P140003Automated Impella Controller (AIC); Product Code: 0042-0000-US;Abiomed, Inc. · Apr 20, 2026 · Under Investigation by firmClass I
  • K213481Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled…Medline Industries, LP · Apr 10, 2026 · 7 products · Component design/selectionClass I
  • K111117NextStep Antegrade Chronic Hemodialysis Catheter, REF: AC-15192-SFX, AC-15232-SFX…Arrow International, LLC · Apr 10, 2026 · 4 products · Nonconforming Material/ComponentClass I
  • K162448Aurous Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20-01 GPN G47308 Sizing…Cook Incorporated · Apr 2, 2026 · 3 products · Under Investigation by firmClass I
  • Z-2066-2026Custom Convenience Kit containing recalled Medline Namic Angiographic Control Syringes…Windstone Medical Packaging, Inc. · Apr 2, 2026 · Device DesignClass I