510(k) · Cleared
ClearedMedical Infrared Thermometer (Model: RST-TC59-1001, RST-TC60-1001)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zhejiang Rongsheng Industrial Co., Ltd. · FLL Continuous Measurement Thermometer
Cleared on Feb 10, 2023 as substantially equivalent to K163516 (Kaz USA, Inc., A Helen of Troy Company, 2017) after a 340-day review. Its family tree reaches back 5 generations to 2001.
- Decided
- Feb 10, 2023
- Review
- 340 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K011291 (2001). No later device cites it as a predicate yet.
- Root · 5 generations backK011291 Temporalscanner Thermometer, SensortouchExergen Corp. · 2001
- 4 generations backK033790 Thermofocus 0800, 0900, 01500 and 0700 SeriesTecnimed S.R.L. · 2004
- 3 generations backK081160 Avita Radar Thermo IR Thermometer, NT1 SeriesAvita Corporation · 2008
- 2 generations backK134043 NO Touch+Forehead NTF 3000 ThermometerKaz USA, Inc (A Subsidiaryof Kaz Inc) · 2014
- 1 generation backK163516 Braun No Touch + Forehead NTF3000 ThermometerKaz USA, Inc., A Helen of Troy Company · 2017
- This deviceK220657 Medical Infrared Thermometer (Model: RST-TC59-1001, RST-TC60-1001)Zhejiang Rongsheng Industrial Co., Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K011291 | Temporalscanner Thermometer, Sensortouch | Exergen Corp. | 2001 | — |
| −4 | K033790 | Thermofocus 0800, 0900, 01500 and 0700 Series | Tecnimed S.R.L. | 2004 | — |
| −3 | K081160 | Avita Radar Thermo IR Thermometer, NT1 Series | Avita Corporation | 2008 | — |
| −2 | K134043 | NO Touch+Forehead NTF 3000 Thermometer | Kaz USA, Inc (A Subsidiaryof Kaz Inc) | 2014 | — |
| −1 | K163516 | Braun No Touch + Forehead NTF3000 Thermometer | Kaz USA, Inc., A Helen of Troy Company | 2017 | — |
| 0 (this device) | K220657 | Medical Infrared Thermometer (Model: RST-TC59-1001, RST-TC60-1001) | Zhejiang Rongsheng Industrial Co., Ltd. | 2023 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FLL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FLL device
- #1 K191829 Microlife Non-Contact Infrared Forehead…score 26.7 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K163516 | Braun No Touch + Forehead NTF3000 ThermometerSummary page 4…tronic Thermometer Regulation class: II Regulation number: 21CFR 880.2910 Panel: General Hospital Product code: FLL Predicative device Predicate Submission Number: K163516 Predicate Device Trade Name: Braun No Touch + Forehead NTF3000 Thermometer Classification name: Clinical Electronic Thermometer… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 6 companies; a new generation was cleared every 4.1 years on median.
- None of the 5 ancestors has a recall.
- 9 other devices also cite its predicate K163516.
How does its category compare?
All FLL devicesFLL Continuous Measurement Thermometer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · FLL
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FLL
131in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FLL
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FLL
73in 2025
MAUDE reports naming product code FLL, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 15 | 81 | 0 | 4 |
| 2008 | 14 | 59 | 0 | 13 |
| 2009 | 13 | 84 | 0 | 9 |
| 2010 | 24 | 88 | 0 | 9 |
| 2011 | 20 | 113 | 1 | 18 |
| 2012 | 17 | 126 | 0 | 26 |
| 2013 | 14 | 149 | 0 | 16 |
| 2014 | 7 | 199 | 0 | 54 |
| 2015 | 3 | 270 | 1 | 53 |
| 2016 | 22 | 157 | 0 | 58 |
| 2017 | 16 | 174 | 2 | 118 |
| 2018 | 35 | 209 | 1 | 51 |
| 2019 | 22 | 198 | 5 | 52 |
| 2020 | 21 | 194 | 0 | 53 |
| 2021 | 43 | 218 | 0 | 115 |
| 2022 | 24 | 218 | 0 | 142 |
| 2023 | 17 | 295 | 0 | 101 |
| 2024 | 13 | 223 | 0 | 118 |
| 2025 | 6 | 131 | 1 | 73 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The Medical Infrared Thermometer is a non-sterile, reusable clinical thermometer intended for the intermittent determination of human body temperature in no touch mode on the center of the forehead as the measurement site on people of one month and above.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220657 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220657: Medical Infrared Thermometer (Model: RST-TC59-1001, RST-TC60-1001).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220657
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026