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The FDA Device Review Tracker
Once a month: notable 510(k), De Novo and PMA decisions, the predicates behind them, review times by product code, and new Class I recalls. Built from FDA’s records and the summaries filed with them.
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Latest issue: September 2026
Read the full issueThe 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)
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
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