# K993950: Cecilia Penguin Multi-Use Thermometer, Model HP-ETO9999

- Pathway: 510(k) (Traditional)
- Applicant: Nien Made Electrnics Corp.
- Decided: Aug 23, 2000 after 275 days
- Product code: FLL (Continuous Measurement Thermometer)
- Device class: 2
- Regulation: 21 CFR 880.2910
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K983295 (1999). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983295: Braun Thermoscan IRT3020/3500 One Secons Ear Thermometer, Model IRT3020/3520, Braun AG (1999) Summary page 1.

## Indications for use
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.

Source page: https://510kreport.com/device/K993950
Methodology: https://510kreport.com/methodology