# K981456: Baby Pacifier Digital Thermometer

- Pathway: 510(k) (Traditional)
- Applicant: K-Jump Health Co., Ltd.
- Decided: Jul 2, 1998 after 70 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. The FDA summary names its predicate without a number.
- (no number) Basis® Baby-Temp Digital Thermometer: named in the summary without a submission number

## Indications for use
The Baby Pacifier Digital Thermometer is a non-sterile, reusable thermometers. They are intended for the measurement of oral body temperatures of infants and young children.

Source page: https://510kreport.com/device/K981456
Methodology: https://510kreport.com/methodology