Cleared Traditional

K222311 - CIRCA MATRIX12 M Esophageal Temperature...

K222311 is an FDA 510(k) clearance for CIRCA MATRIX12 M Esophageal Temperature..., manufactured by Circa Scientific, Inc.. The device is a Class 2 Cardiovascular device with product code FLL cleared through the Traditional 510(k) pathway after a 297-day FDA review.

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

FDA 510(k) Submission Details - K222311

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.

FLL Device Classification - Class 2, Special Controls

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 362
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
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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