Sleep Sentry(Tm)

No FDA recalls found in the data synced 22 Oct 2026.

Generic Name

Monitor, skin resistance/skin temperature, for insulin reactions

PMA Number

P810044 ↗

FDA Product Code

LMY

Device Class

Class III

Advisory Committee

General Hospital

FDA Decision

APPR Approved

PMA Supplement

S001

• What clinical setting is the Sleep Sentry Monitor primarily designed for, and how does it help patients during sleep?

  The Sleep Sentry Monitor is specifically designed for use in **general hospital settings**, where it helps detect early warning signs of insulin reactions—such as hypoglycemia (low blood sugar) or hyperglycemia (high blood sugar)—by continuously measuring **skin resistance and temperature variations**. This is particularly useful for patients who may experience reactions during sleep, when symptoms might otherwise go unnoticed until they become severe.

• Is the Sleep Sentry Monitor intended for single-use or reusable applications, and what maintenance is required?

  The Sleep Sentry Monitor is **not single-use**; it is supplied as a **reusable medical instrument**. Since it is not sterile out-of-the-box, proper **cleaning and maintenance** are required after each use to ensure accuracy and hygiene. The manufacturer provides guidelines for this process, which must be followed to comply with clinical standards and device performance.

• What regulatory pathway was followed for the Sleep Sentry Monitor, and what does its classification as a Class 3 device mean?

  The Sleep Sentry Monitor was authorized through the **FDA Premarket Approval (PMA) process**, with the approval number **P810044**. Its classification as a **Class 3 device** indicates it is subject to stringent regulatory oversight due to its role in detecting critical physiological changes related to insulin reactions, ensuring high levels of safety and effectiveness before market authorization.

• How does the Sleep Sentry Monitor differ from other monitoring devices in terms of its detection capabilities?

  Unlike some monitoring devices that rely solely on blood glucose meters or continuous glucose monitors (CGMs), the Sleep Sentry Monitor specifically detects **skin resistance and temperature fluctuations**—two physiological markers associated with insulin reactions. This dual-measurement approach allows it to provide **early warning signs of hypoglycemia or hyperglycemia**, particularly during sleep, when patients may not be actively monitoring their condition.