# K962497: Q-Tips, Faichney, Private Label

- Pathway: 510(k) (Traditional)
- Applicant: Faichney Medical Co.
- Decided: Oct 8, 1996 after 104 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 K852954 (1985). 1 ancestor in all.
3 later devices descend from it; 1 cites 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)
- K852954: B-D Digital Fever Thermometer, Bd Becton Dickinson Vacutainer Systems Preanalytic (1985) Summary page 2.

## Most influential descendants
- K992601: Temp Teller - Digital Thermometer, Models DT-101, DT-102, DT-103, DT-201, DT-202, DT-203 (1999), 2 descendants of its own
- K042202: Tempteller - High Speed Digital Thermometers, Models DT-302, DT-312, DT-412, DT-502 (2004), 1 descendant of its own
- K101232: Joinsoon Electronics MFG CO. LTD High Speed Digital Thermometer, Model TC-001 (2010), 0 descendants of its own

## Indications for use
The Faichney Medical Company and Becton-dickinson digital thermometers are intended for measuring body temperature using oral, rectal, or axillary sites.

Source page: https://510kreport.com/device/K962497
Methodology: https://510kreport.com/methodology