Cleared Traditional

Circa S-Cath M Esophageal Temperature Probe and Temperature Monitoring System (K200943) - FDA 510(k) Clearance

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

K200943 · Circa Scientific, LLC · Cardiovascular device
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Dec 2021
Decision
618d
Days
Class 2
Risk

K200943 is an FDA 510(k) clearance for the Circa S-Cath M Esophageal Temperature Probe and Temperature Monitoring System. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Circa Scientific, LLC (Englewood, US). The FDA issued a Cleared decision on December 17, 2021 after a review of 618 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Circa Scientific, LLC devices

Submission Details

510(k) Number K200943 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 2020
Decision Date December 17, 2021
Days to Decision 618 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
493d slower than avg
Panel avg: 125d · This submission: 618d
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 K200943.
Non-contact Infrared Thermometer, Models JXB-315, JXB-319, JXB-320, JXB-311
K213082 · Guangzhou Berrcom Medical Device Co., Ltd. · Jan 2022
Infrared Thermometer
K211752 · Beijing Choice Electronic Technology Co., Ltd. · Jan 2022
Infrared Thermometer
K210564 · Alicn Medical (Shenzhen), Inc. · Jan 2022
Infrared thermometer, models KFT-22M, KFT-22, KFT-23, KFT-24, KFT-25, KFT-26, KFT-27, KFT-28
K201600 · Kangfu Medical Equipment Factory · Dec 2021
Infrared forehead thermometer LD-FT-100B
K211629 · Honsun (Nantong) Co., Ltd. · Dec 2021
Non-Contact Infrared Thermometer, model HL710H
K211744 · Health & Life Co., Ltd. · Nov 2021