SomniProbe Model Number 10093 Modification

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

Full name

Somniprobe(R) Model Number 10093, Modification

510(k) Number

K912234 ↗

FDA Product Code

BZG

Device Class

Class II

Regulation

21 CFR Part 868.1840

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• ECG Female-to-Pin Snap Electrode W/Leads and Ext.

  Class II

  FDA 510(k) K911990 Active Cleared 21 Jun 1991

• Gold Cup EEG Cutaneous Electrode W/Lead and Ext.

  Class II

  FDA 510(k) K911989 Active Cleared 30 Jul 1991

• Somnimic (R)

  Class II

  FDA 510(k) K912817 Active Cleared 26 Jul 1991

• What clinical conditions is the SomniProbe Model 10093 Modification primarily used to evaluate?

  The SomniProbe Model 10093 Modification is designed to measure airflow during respiratory studies, specifically for assessing nasal and buccal airflow. This aids in diagnosing and evaluating sleep-related breathing disorders, such as sleep apnea, as well as other respiratory conditions that may impact airflow during sleep or anesthesia.

• Is the SomniProbe Model 10093 Modification intended for single-use or reusable applications in clinical settings?

  The SomniProbe Model 10093 Modification is explicitly described as a reusable medical instrument, meaning it is intended for repeated use in clinical environments after proper cleaning and maintenance. No information regarding single-use or disposable variants is provided in the available data.

• What regulatory pathway was followed for FDA clearance of the SomniProbe Model 10093 Modification?

  The SomniProbe Model 10093 Modification was cleared through the FDA 510(k) pathway under the classification of a Class II device (regulation number 868.1840). The submission was reviewed by the Anesthesiology (AN) Advisory Committee and determined to be substantially equivalent to a predicate device, with a traditional clearance type (K912234).

• Are there any specific sterility requirements or MRI safety considerations mentioned for the SomniProbe Model 10093 Modification?

  The provided data does not include any details regarding sterility requirements or MRI safety for the SomniProbe Model 10093 Modification. Users should follow standard clinical protocols for cleaning, disinfection, and handling reusable medical devices, and consult manufacturer guidelines for MRI compatibility if needed.

• What medical specialty is the SomniProbe Model 10093 Modification primarily associated with, and how does this relate to its intended use?

  The SomniProbe Model 10093 Modification is primarily associated with anesthesiology, as indicated by its regulatory classification and advisory committee review. While it functions as a spirometer for measuring airflow, its intended use in this specialty likely relates to preoperative respiratory assessments, intraoperative monitoring, or postoperative evaluations where airflow dynamics are critical, such as in patients with suspected sleep apnea or other respiratory conditions.