510(k) · Cleared
ClearedInfrared thermometer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Pango Electronic Co., Ltd. · FLL Continuous Measurement Thermometer
Cleared on Apr 3, 2019 as substantially equivalent to K152748 (Kaz USA, Inc (A Subsidiary of Helen of Troy, Inc), 2016) and 1 other predicate after a 195-day review. Its family tree reaches back 5 generations to 2001. 3 later devices descend from it.
- Decided
- Apr 3, 2019
- Review
- 195 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K011291 (2001). 9 ancestors in all. 3 later devices descend from it, 3 citing it directly.
- 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 deviceK182597 Infrared thermometerShenzhen Pango Electronic Co., Ltd. · 2019
- Descendant · cites it directly · 0 of its ownK212346 Infrared Thermometer, Model: PG-IRT1612, PG-IRT1613, PG-IRT1615…Shenzhen Pango Medical Electronics Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK202591 Body Infrared Thermometer HT-820DDongguan Xintai Instrument Co., Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK201980 Infrared ThermometerContec Medical Systems Co.,Ltd · 2020
Most influential descendants
Showing 3 of 3 · See all- K212346Infrared Thermometer, Model: PG-IRT1612, PG-IRT1613, PG-IRT1615, PG-IRT1618Shenzhen Pango Medical Electronics Co., Ltd. · 2022 · cites it directly0descendants
- K202591Body Infrared Thermometer HT-820DDongguan Xintai Instrument Co., Ltd. · 2021 · cites it directly0descendants
- K201980Infrared ThermometerContec Medical Systems Co.,Ltd · 2020 · cites it directly0descendants
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) | K182597 | Infrared thermometer | Shenzhen Pango Electronic Co., Ltd. | 2019 | — |
| +1 | K212346 | Infrared Thermometer, Model: PG-IRT1612, PG-IRT1613, PG-IRT1615, PG-IRT1618 | Shenzhen Pango Medical Electronics Co., Ltd. | 2022 | — |
| +1 | K202591 | Body Infrared Thermometer HT-820D | Dongguan Xintai Instrument Co., Ltd. | 2021 | — |
| +1 | K201980 | Infrared Thermometer | Contec Medical Systems Co.,Ltd | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
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? (2)
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 |
|---|---|---|---|
| * | K152748 | Braun Thermoscan PRO 6000 Ear ThermometerSummary page 6…based on OBJ, NTC and AMB, and then transfer to screen for display. 5. Identification of Predicate Devices Predicate Device 1 510(k) Number: K152748; Device Name: Braun Thermoscan® PRO 6000 Ear Thermometer Predicate Device 2 510(k) Number: K163516;… | 2016 |
| * | K163516 | Braun No Touch + Forehead NTF3000 ThermometerSummary page 6…Predicate Device 1 510(k) Number: K152748; Device Name: Braun Thermoscan® PRO 6000 Ear Thermometer Predicate Device 2 510(k) Number: K163516; Device Name: Braun No Touch + Forehead NTF3000 Thermometer; 6. Non-Clinical Test Conclusion Non clinical t… | 2017 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 18 years and passes through 6 companies; a new generation was cleared every 2.9 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K212346 (Shenzhen Pango Medical Electronics Co., Ltd., 2022) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K152748.
How does its category compare?
All FLL devicesFLL Continuous Measurement Thermometer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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?
PG-IRT1601 Infrared Ear Thermometer is intended to measure human body temperature by measuring ear canal.
PG-IRT1602 Infrared Forehead Thermometer is intended to measure human body temperature by measuring forehead.
PG-IRT1603 Infrared Ear/Forehead Thermometer is intended to measure human body temperature by measuring ear canal or forehead.
The device can be used on people of all ages.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182597 · printed Nov 5, 2026
Cite this page
510(k) Report. “K182597: Infrared thermometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K182597
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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