Cleared Traditional

THERMOCLICK (K222057) - FDA 510(k) Clearance

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

K222057 · T&R BIOFAB CO., Ltd. · General Hospital
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Dec 2023
Decision
511d
Days
Class 2
Risk

K222057 is an FDA 510(k) clearance for the THERMOCLICK. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by T&R BIOFAB CO., Ltd. (Siheung-Si, KR). The FDA issued a Cleared decision on December 5, 2023 after a review of 511 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2910 - the FDA general hospital device 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 General Hospital submissions.

View all T&R BIOFAB CO., Ltd. devices

Submission Details

510(k) Number K222057 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 2022
Decision Date December 05, 2023
Days to Decision 511 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
382d slower than avg
Panel avg: 129d · This submission: 511d
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 General Hospital devices follow this clearance model.

Regulatory Consultant

Lighten Bridge, LLC
Edward Park

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K222057.
VitalDetect
K231625 · Wellvii, Inc. · Feb 2024
Digital Thermometer, Model T28, T28L
K232678 · Guangdong Genial Technology Co., Ltd. · Jan 2024
Electronic Thermometer, Model: AET-F331, AET-F332, AET-F333, AET-F344, AET-F345, AET-F346, AET-F354, AET-F355, AET-F356, AET-F361, AET-F362, AET-F363, AET-F371, AET-F372, AET-F373, AET-F381, AET-F382, AET-F383
K232338 · Alicn Medical (Shenzhen), Inc. · Dec 2023
Infrared Thermometer (AOJ-20A)
K232128 · Shenzhen AOJ Medical Technology Co., Ltd. · Oct 2023
Reusable Temperature Probe, Disposable Temperature Probe
K223807 · Shenzhen Sino-K Medical Technology Co.,Ltd · Aug 2023
Celsi Monitor
K230298 · Hadleigh Health Technologies · Aug 2023