# K983619: Barchens Company Digital Pacifier Thermometer

- Pathway: 510(k) (Traditional)
- Applicant: Barchens Co.
- Decided: Nov 2, 1998 after 18 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: 2 generations back to K952073 (1995). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972259: Pro Check Digital Pacifier Thermometer, Micro Weiss Electronics (1997) Summary page 1.
- K952073: Paci-Temp, Pacifier with Digital Thermometer, Intelligent Product Limited Co. (1995) Summary page 1.
- K962991: Basis Baby-Temp Pacifier Digital Therometer, Polymedica Industries, Inc. (1996) Summary page 1.

## Indications for use
The Barchens Digital Pacifier Thermometer is a non-sterile, re-usable clinical thermometer intended for the determination of oral body temperature in infants to children five years of age.

Source page: https://510kreport.com/device/K983619
Methodology: https://510kreport.com/methodology