Cleared Traditional

K202603 - Temp Pal

K202603 is an FDA 510(k) clearance for Temp Pal, 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 317-day FDA review.

K202603 · Iweecare Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2021
Decision
317d
Days
Class 2
Risk

K202603 is an FDA 510(k) clearance for the Temp Pal. 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 July 22, 2021 after a review of 317 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 - K202603

510(k) Number K202603 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 2020
Decision Date July 22, 2021
Days to Decision 317 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
188d slower than avg
Panel avg: 129d · This submission: 317d
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 K202603.
Sensatronic Reusable Temperature Probes
K203643 · Sensatronic GmbH · Aug 2021
Disposable Ear Thermometer Probe Cover
K203431 · Huaian Zhongxin Packing Material Co., Ltd. · Jul 2021
Infrared Forehead Thermometer, Model BSX976
K202296 · Shenzhen Bsx Technology Electronics Co., Ltd. · Jul 2021
Infrared Forehead Thermometer
K202741 · Shenzhen Combei Technology Co., Ltd. · Jul 2021
Infrared Thermometer
K202440 · Shenzhen Sonida Digital Technology Co., Ltd. · Jun 2021
Radius T wearable thermometer
K203215 · Masimo Corporation · Jun 2021