Cleared Traditional

K222588 - Temp Pal (Smart Thermometer Patch) Mode...

K222588 is an FDA 510(k) clearance for Temp Pal (Smart Thermometer Patch) Mode..., manufactured by Iweecare Co., Ltd.. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K222588 · Iweecare Co., Ltd. · General Hospital
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Optimized for regulatory review, auditing and printing
Feb 2023
Decision
175d
Days
Class 2
Risk

K222588 is an FDA 510(k) clearance for the Temp Pal (Smart Thermometer Patch) Model Number: STP-MB01-1. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Iweecare Co., Ltd. (Taipei City, TW). The FDA issued a Cleared decision on February 17, 2023 after a review of 175 days - an extended review cycle.

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

View all Iweecare Co., Ltd. devices

FDA 510(k) Submission Details - K222588

510(k) Number K222588 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 2022
Decision Date February 17, 2023
Days to Decision 175 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
46d slower than avg
Panel avg: 129d · This submission: 175d
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 General Hospital devices follow this clearance model.

Regulatory Peers - FLL Continuous Measurement Thermometer

All 372
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K222588.
CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring System
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K220276 · Truly Instrument Limited · Feb 2023
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Digital Thermometer, Model: DT007, DT008
K214077 · Guangzhou Berrcom Medical Device Co., Ltd. · Jan 2023
Infrared Thermometer, models AOJ-20A, AOJ-20B, AOJ-20C, AOJ-20D, AOJ-20E, AOJ-20F, AOJ-20H, AOJ-20M, AOJ-20T, AOJ-20R and AOJ-20Y
K221039 · Shenzhen AOJ Medical Technology Co., Ltd. · Dec 2022