Cleared Traditional

CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring System

K222311 · Circa Scientific, Inc. · Cardiovascular
May 2023
Decision
297d
Days
Class 2
Risk

About This 510(k) Submission

K222311 is an FDA 510(k) clearance for the CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring System, a Continuous Measurement Thermometer (Class II — Special Controls, product code FLL), submitted by Circa Scientific, Inc. (Englewood, US). The FDA issued a Cleared decision on May 25, 2023, 297 days after receiving the submission on August 1, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 880.2910.

Submission Details

510(k) Number K222311 FDA.gov
FDA Decision Cleared SESE
Date Received August 01, 2022
Decision Date May 25, 2023
Days to Decision 297 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code FLL — Continuous Measurement Thermometer
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.2910
Definition A Continuous Measurement Thermometer Is A Clinical Electronic Thermometer Indicated To Measure The Body Or Skin Temperature Of A Person Continuously Or In Specified Intervals. Under This Regulation, This Product Code Represents Non-exempt Devices. For More Information, See 90 Fr 25889, Available At Https://www.govinfo.gov/content/pkg/fr-2025-06-18/pdf/2025-11207.pdf.

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