Sample brief Week of September 23, 2026

What subscribers got this week

A real brief, built from public FDA records via openFDA. Subscriber briefs are filtered to the product codes on their watchlist; this sample shows a cross-section.

Competitor clearedSample

Suzhou Microport Orthorecon Co., Ltd. received 510(k) clearance K262293 for the EVOLUTION MPX Total Knee System (product code JWH, device class 2), FDA decision date September 10, 2026.

Source: FDA 510(k) database via openFDA, accessed September 23, 2026. Linked in this window: 0 recalls naming this K number; 0 MAUDE reports referencing it.

Competitor clearedSample

OMRON Healthcare, Inc. received 510(k) clearance K261929 for the Upper Arm Blood Pressure Monitor (BP7155D) (product code DXN, device class 2), FDA decision date September 10, 2026.

Source: FDA 510(k) database via openFDA, accessed September 23, 2026. Linked in this window: 0 recalls naming this K number; 0 MAUDE reports referencing it.

Recall postedSample

Boston Scientific Corporation recall posted September 16, 2026 (initiated July 22, 2026). Reason stated: a subset of power adapters used with the StoneSmart Connect Console may exhibit higher-than-expected resistance in the electrical grounding path.

Product code FGB. Source: FDA recall database via openFDA, accessed September 23, 2026. Record: res_event_number=99630.

FDA disclaimer (verbatim): Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Clearance Wire is not regulatory advice. We surface public data and join it up so you can see what moved. Not affiliated with the FDA.

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