510(k) · Cleared
ClearedCecilia Penguin Multi-Use Thermometer, Model HP-ETO9999
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nien Made Electrnics Corp. · FLL Continuous Measurement Thermometer
Cleared on Aug 23, 2000 as substantially equivalent to K983295 (Braun AG, 1999) after a 275-day review. Its family tree reaches back 1 generation to 1999.
- Decided
- Aug 23, 2000
- Review
- 275 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K983295 (1999). No later device cites it as a predicate yet.
- Root · 1 generation backK983295 Braun Thermoscan IRT3020/3500 One Secons Ear Thermometer, Model…Braun AG · 1999
- This deviceK993950 Cecilia Penguin Multi-Use Thermometer, Model HP-ETO9999Nien Made Electrnics Corp. · 2000
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K983295 | Braun Thermoscan IRT3020/3500 One Secons Ear Thermometer, Model IRT3020/3520 | Braun AG | 1999 | — |
| 0 (this device) | K993950 | Cecilia Penguin Multi-Use Thermometer, Model HP-ETO9999 | Nien Made Electrnics Corp. | 2000 | — |
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 |
|---|---|---|---|
| * | K983295 | Braun Thermoscan IRT3020/3500 One Secons Ear Thermometer, Model IRT3020/3520Summary page 1…ification ProCode ’ Name 880.2910, 80 FLL Clinical electronic thermometer . The Cecilia® Thermometer is substantially equivalent to the Braun Thermoscan® IRT 3020/3520 (K983295). . The Cecilia® Thermometer consists of an IR sensor, an electronic signal processing detector, a digital LCD display, and disp… | 1999 |
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?
- Its one ancestor has no recall.
- 8 other devices also cite its predicate K983295.
How does its category compare?
All FLL devicesFLL Continuous Measurement Thermometer: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
For intermittent measurement of body temperature in patients of all ages in the home environment by measurement of infrared radiation emitted, solely, from the tympanic membrane.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K993950 · printed Nov 4, 2026
Cite this page
510(k) Report. “K993950: Cecilia Penguin Multi-Use Thermometer, Model HP-ETO9999.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K993950
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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