510(k) Report

FDA Device Review Tracker

June 2026

FDA cleared 324 510(k)s, granted 1 De Novo request and approved 6 original PMAs in June 2026; the median 510(k) took 147 days from receipt. FDA posted 8 Class I recall events.

The month in numbers

510(k) clearances

324

up 10% on a year earlier

De Novo grants

1

down 67% on a year earlier

Original PMA approvals

6

up 100% on a year earlier

Median 510(k) review

147days

Prior 12 months: 128 days

309 of the month’s decisions name a predicate we could read; 32 have a Class I recall somewhere in their family tree.

New device types (De Novo)

  • DEN250025Syncron-EAutonomous Healthcare, Inc. · 2026Jun 18, 2026

The predicates cited most this month

  • K190651ERBECRYO 2 Cryosurgical Unit; ERBECRYO 2 1-pedal footswitch, Extension cable f. ERBECRYO 2 footswitch…Erbe Elektromedizin GmbH · 20202this month
  • K240208DESS Dental Smart SolutionsTerrats Medical SL · 20242this month
  • K121793AN Evo 1, CS Evo 1, Contact Mini, ApollonAudifon-USA, Inc. · 20122this month
  • K222081ID-510 iRestore EliteFreedom Laser Therapy, Inc. · 20222this month
  • K172830Double Medical Femoral Nail SystemDouble Medical Technology, Inc. · 20182this month

The deepest new lineages

  • K260844ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound System;ACUSON Origin…Siemens Medical Solutions USA, Inc. · 202635generations
  • K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd. · 202633generations
  • K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc. · 202632generations
  • K260885VERAFEYE Imaging and Guidance System (VF-VIS-002)Luma Vision Limited · 202631generations
  • K260810Anteralign LS coverplateTyber Medical, LLC · 202630generations

Busiest product codes

  • QIHAutomated Radiological Image Processing Software11decisions
  • GEIElectrosurgical, Cutting & Coagulation & Accessories9decisions
  • HGXPump, Breast, Powered8decisions
  • NHAAbutment, Implant, Dental, Endosseous6decisions
  • ITIWheelchair, Powered6decisions
  • HRSPlate, Fixation, Bone5decisions

Class I recall events (8)

  • K243529Baxter Duo-Vent Solution Set and Male Luer Lock Adapter, Product Code 1C8507; Solution…Baxter Healthcare Corporation · Jun 30, 2026 · Under Investigation by firmClass I
  • K152068Resmed Astral 100/150 Resmed Astral 100/50 is a ventilator system that provides…ResMed Ltd. · Jun 25, 2026 · Component design/selectionClass I
  • P030017INFINION CX LEAD KIT, 50CM, Model: SC-2317-50, Material: M365SC2317500; INFINION CX LEAD…Boston Scientific Neuromodulation Corporation · Jun 17, 2026 · Device DesignClass I
  • K192769ABIOMED Impella CP Introducer Kit 14 Fr, 13 cm, Pump Set Code 0052-0038, containing Kit…Abiomed, Inc. · Jun 11, 2026 · 13 products · Under Investigation by firmClass I
  • K122084Abiomed REF: 0052-3006, Introducer Kit for Impella Hemostatic Peel Away Introducer…Oscor Inc. · Jun 10, 2026 · 3 products · Device DesignClass I
  • K213481MEDLINE medical procedure convenience kit labeled as: 1) TOTAL KNEE-LF, Medline kit SKU…Medline Industries, LP · Jun 8, 2026 · 2 products · Nonconforming Material/ComponentClass I
  • K213481MEDLINE convenience kits labeled as: 1) C-SECTION, Medline SKU DYNJ910835; 2) C-SECTION…Medline Industries, LP · Jun 5, 2026 · 3 products · Under Investigation by firmClass I
  • K980196General Biospy Tray, REF: GUTS1000Argon Medical Devices, Inc · Jun 1, 2026 · 6 products · Material/Component ContaminationClass I