FDA Device Review Tracker
August 2026
FDA cleared 248 510(k)s, granted 5 De Novo requests and approved 3 original PMAs in August 2026; the median 510(k) took 142 days from receipt. FDA posted 9 Class I recall events.
The month in numbers
510(k) clearances
248
down 2% on a year earlier
De Novo grants
5
up 400% on a year earlier
Original PMA approvals
3
down 50% on a year earlier
Median 510(k) review
142days
Prior 12 months: 128 days
235 of the month’s decisions name a predicate we could read; 33 have a Class I recall somewhere in their family tree.
New device types (De Novo)
- DEN250049Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring SystemAbbott Diabetes Care · 2026Aug 25, 2026
- DEN250067ReneuRx™ (Neural Ice)Brixton Biosciences · 2026Aug 21, 2026
- DEN250026AvuluxMatap Ii, LLC · 2026Aug 21, 2026
- DEN250043Qoramatic Automated Stool ManagementCm Technologies, Inc. · 2026Aug 20, 2026
- DEN250046Aletta® Autonomous Robotic Phlebotomy Device (ARPD™) (Gen1 US)Vitestro · 2026Aug 19, 2026
The predicates cited most this month
- K160907DePuy Actis DuoFix Hip ProsthesisDepuy (Ireland) · 20162this month
- K232202Aperio GT 450 DXLeica Biosystems Imaging, Inc. · 20242this month
- K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical · 20242this month
- K071378Modification to Empower CT/Cta Injector System, Models 9800/9900 Product SeriesE-Z-Em, Inc. · 20071this month
- K250904Atalante XWandercraft SAS · 20251this month
The deepest new lineages
- K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus; EmbraceMini; Empatica…Empatica S.r.l. · 202641generations
- K260211Dashboard (P007000)Hill-Rom, Inc. · 202632generations
- K251508Telemetry Monitor (iT30, iT50)Edan Instruments, Inc. · 202630generations
- K261668Venue GoGE Medical Systems Ultrasound and Primary care Diagnostics, LLC · 202629generations
- K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC · 202629generations
Busiest product codes
- QIHAutomated Radiological Image Processing Software8decisions
- OHSLight Based Over The Counter Wrinkle Reduction5decisions
- KNWInstrument, Biopsy4decisions
- GEXPowered Laser Surgical Instrument4decisions
- NRYCatheter, Thrombus Retriever4decisions
- DXNSystem, Measurement, Blood-Pressure, Non-Invasive4decisions
Class I recall events (9)
- K121694Imager II Angiographic Catheters M001314001 IMAGER II/5/ST/65/038 BX5; M001314011 IMAGER…Boston Scientific Corporation · Aug 24, 2026 · Process controlClass I
- K022209BD Alaris Pump Infusion Sets 10561554* 10885403232565 50885403232563 BD Alaris Pump…BD Switzerland Sarl · Aug 19, 2026 · Device DesignClass I
- Z-3227-2026Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories, Hand Pendants…Medline Industries, LP · Aug 14, 2026 · 2 products · Device DesignClass I
- P140003Impella Optical Controller with the below product descriptions and corresponding Product…Abiomed, Inc. · Aug 12, 2026 · 3 products · Under Investigation by firmClass I
- Z-3122-2026Medline Convenience Kits: 1) OPEN HEART ADULT, Catalog Number: CDS840396Y; 2) FULL LINE…Medline Industries, LP · Aug 11, 2026 · 7 products · Nonconforming Material/ComponentClass I
- K911780INCA (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP, Replacement Set. Stay-Flex tubing…CooperSurgical, Inc. · Aug 11, 2026 · 2 products · Device DesignClass I
- K133456Power-Trialysis Short-Term Straight Dialysis Catheter, REF: 5605150; Power-Trialysis…Bard Access Systems, Inc. · Aug 10, 2026 · 2 products · Material/Component ContaminationClass I
- Z-3153-2026Haylard BASIC BIOPSY TRAY; Model/Item Number (Kit): PM415;AVID Medical, Inc. · Aug 10, 2026 · 4 products · Nonconforming Material/ComponentClass I
- Z-3090-2026Bravo CF capsule delivery device, 5-pack, Product Number FGS-0635, Bravo CF capsule…Given Imaging Ltd. · Aug 6, 2026 · Nonconforming Material/ComponentClass I