# K954792: Lumiscope Model 2018 Thermometer

- Pathway: 510(k) (Traditional)
- Applicant: Lumiscope Co., Inc.
- Decided: Jun 21, 1996 after 247 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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) Hanson Scale Co Clinical Electronic Thermometer - Model 7616-10: named in the summary without a submission number

## Most influential descendants
- K070028: Classic/Hypothermia, Flexible, 10-Second, Left-Right Handed, Basal, Lightweight-Probe Digital Clinical Thermometer (2007), 0 descendants of its own

## Indications for use
It is indicated for use in the measurement of oral and axillary temperature. It is not intended for rectal (rectum) temperature measurement. The device also provides a clock function when not in the temperature mode. The Lumiscope Model 2018 Thermometer is intended for use by adults and may be used by the infant or pediatric patient population for measurements of axillary body temperature or for measurements of oral body temperature if the child is able to hold the thermometer beneath the tongue while his mouth is closed.

Source page: https://510kreport.com/device/K954792
Methodology: https://510kreport.com/methodology