Cleared Traditional

K220657 - Medical Infrared Thermometer (Model: RS...

K220657 is an FDA 510(k) clearance for Medical Infrared Thermometer (Model: RS..., manufactured by Zhejiang Rongsheng Industrial Co., Ltd.. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 340-day FDA review.

K220657 · Zhejiang Rongsheng Industrial Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2023
Decision
340d
Days
Class 2
Risk

K220657 is an FDA 510(k) clearance for the Medical Infrared Thermometer (Model: RST-TC59-1001, RST-TC60-1001). Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Zhejiang Rongsheng Industrial Co., Ltd. (Xiaoshun Town, Jinhua, CN). The FDA issued a Cleared decision on February 10, 2023 after a review of 340 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 Zhejiang Rongsheng Industrial Co., Ltd. devices

FDA 510(k) Submission Details - K220657

510(k) Number K220657 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 2022
Decision Date February 10, 2023
Days to Decision 340 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
211d slower than avg
Panel avg: 129d · This submission: 340d
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 374
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K220657.
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
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
Infrared Thermometer (Model: Y20001, Y20002)
K221800 · Zhangzhou Easepal Medical Science and Technology Co., Ltd. · Dec 2022