Argyle Acc-U-Therm W/Temperature Probe

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

510(k) Number

K812976 ↗

FDA Product Code

BZT

Device Class

Class II

Regulation

21 CFR Part 868.1920

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

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See all devices from Sherwood Medical Co. →

• What clinical scenarios is the Argyle Accu-Therm with Temperature Probe designed for, and how does it differ from a standard esophageal stethoscope?

  The Argyle Accu-Therm with Temperature Probe is specifically designed for anesthesia procedures where precise monitoring of esophageal temperature is critical. Unlike traditional esophageal stethoscopes, it integrates electrical conductors to measure temperature alongside auscultation, ensuring real-time physiological data during high-risk interventions like surgeries or intensive care. This dual functionality helps clinicians correlate respiratory sounds with thermal stability, improving patient safety in critical care settings.

• Is the device reusable, or is it intended for single-use only? How should it be handled to maintain sterility?

  The Argyle Accu-Therm with Temperature Probe is intended for single-use only to ensure patient safety and device integrity. Since it is supplied sterile, proper sterile handling protocols must be followed during storage, preparation, and use. This includes maintaining sealed packaging until immediate use and adhering to standard sterile medical device protocols to prevent contamination, as outlined in its regulatory compliance requirements.

• What regulatory pathway was followed for FDA clearance, and what does this mean for clinicians using the device?

  The device received FDA 510(k) clearance under product code BZT and regulation 868.1920, with a decision of Substantially Equivalent (SESE) by the Anesthesiology Advisory Committee (AN). This means the FDA determined it is as safe and effective as a legally marketed predicate device, ensuring it meets established performance standards for esophageal stethoscopes with temperature monitoring. Clinicians can rely on this clearance as validation of its safety and functionality for use in anesthesia procedures.

• Are there different sizes or models available for the Argyle Accu-Therm with Temperature Probe, or is it a one-size-fits-all design?

  The provided data does not specify distinct sizes or models for the Argyle Accu-Therm with Temperature Probe, implying it may be designed as a single standardized configuration for general anesthesia use. However, the device’s adaptability to various patient anatomies is implied by its classification as an esophageal stethoscope with electrical conductors, which suggests it is engineered to fit standard esophageal insertion protocols. For precise sizing details, consulting the manufacturer’s technical documentation would be recommended.

• How should the device be stored to ensure it remains effective until its intended single-use?

  Since the Argyle Accu-Therm with Temperature Probe is sterile and single-use, it must be stored in its original, unopened packaging in a clean, dry environment protected from extreme temperatures, moisture, and direct sunlight. The sealed packaging helps preserve sterility and device integrity until immediate clinical use. Failure to maintain these conditions could compromise performance or sterility, so adherence to sterile medical device storage guidelines is essential.