# K031907: Npac Digital Thermometer, Models ET 300, 301, 350, 351; ET 400, 401, 450, 451; ET 500, 501, 550, 551

- Pathway: 510(k) (Traditional)
- Applicant: Norm Pacific Automation Corp.
- Decided: Aug 21, 2003 after 62 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
For intermittent measurement of body temperature in patient of all ages in home environment. The device is reusable and intended for oral, axillary or rectal temperature measurements.

Source page: https://510kreport.com/device/K031907
Methodology: https://510kreport.com/methodology