# K962991: Basis Baby-Temp Pacifier Digital Therometer

- Pathway: 510(k) (Traditional)
- Applicant: Polymedica Industries, Inc.
- Decided: Sep 12, 1996 after 42 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.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices 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) Questech International, Inc. WeeCare™ Pacifier Thermometer: named in the summary without a submission number
- (no number) Intelligent Product Limited Company Paci-Temp Pacifier with Digital Thermometer: named in the summary without a submission number

## Most influential descendants
- K972259: Pro Check Digital Pacifier Thermometer (1997), 3 descendants of its own
- K051100: Modification to:  Microlife Digital Pacifier Thermometer, Model MT1751Q (2005), 1 descendant of its own
- K120671: Digital Pacifier Thermometer (Model NO.: TM-03) (2013), 0 descendants of its own
- K983619: Barchens Company Digital Pacifier Thermometer (1998), 0 descendants of its own

## Indications for use
The Basis® Baby-Temp Pacifier Digital Thermometer is a clinical thermometer intended for the determination of oral body temperature determination in infants and young children.

Source page: https://510kreport.com/device/K962991
Methodology: https://510kreport.com/methodology