# K021851: Digital Clinical Thermometer, Model KD-193

- Pathway: 510(k) (Abbreviated)
- Applicant: K-Jump Health Co., Ltd.
- Decided: Jul 17, 2002 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
Longest line of descent: 1 generation back to K903590 (1990). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K903590: Kejump Digital Clinical Thermometer, K-Jump Health Co., Ltd. (1990) Summary page 2.
- K943695: Suretemp, Advanced Bioresearch Assoc. (1995) Summary page 2.

## Indications for use
The Digital Clinical Thermometer Model KD-193 is intended to measure the human body temperature and is specifically indicated to operate in either predictive mode or regular mode orally, rectally or under the arm.

Source page: https://510kreport.com/device/K021851
Methodology: https://510kreport.com/methodology