Cleared Traditional

CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring System (K222311) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

K222311 is an FDA 510(k) clearance for the CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring System. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Circa Scientific, Inc. (Englewood, US). The FDA issued a Cleared decision on May 25, 2023 after a review of 297 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 880.2910 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Circa Scientific, Inc. devices

Submission Details

510(k) Number K222311 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
172d slower than avg
Panel avg: 125d · This submission: 297d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FLL Continuous Measurement Thermometer
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - FLL Continuous Measurement Thermometer

All 215
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K222311.
e-Celsius Medical System
K210924 · Bodycap · Jun 2023
NC° Thermometer (Gen 3), Model Number: NCTG3
K223522 · Xiamen Intretech, Inc. · Jun 2023
Infrared Thermometer
K222248 · Alicn Medical (Shenzhen), Inc. · Jun 2023
Digital Thermometer (Model QT001)
K223044 · Shen Zhen Rong Feng Technology Co., Ltd. · May 2023
Infrared Thermometer TET-351
K220276 · Truly Instrument Limited · Feb 2023
Temp Pal (Smart Thermometer Patch) Model Number: STP-MB01-1
K222588 · Iweecare Co., Ltd. · Feb 2023