# K070342: Clinical Electronic Thermometer, Models TP11403 Through TP11413

- Pathway: 510(k) (Traditional)
- Applicant: American I.V. Products, Inc.
- Decided: Mar 19, 2007 after 41 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: 4 generations back to K896030 (1989). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992638: Dinamap Pro Series Monitor, Models 100, 200, 300, 400, Critikon Company, LLC (2000) Summary page 1.
- K874378: Dinamap Vital Signs Monitor, Model 8100T, Critikon Company, LLC (1987) Summary page 1.
- K050230: Turbo Temp Trio, Cardinal Health, Alaris Products (2005) Summary page 1.
- K955846: Model 2082 Temp Plus Iii Thermometer/Model 2087 Temp Plus Iii Wall Mount Thermometer, Y (1996) Summary page 1.
- K860436: Ivac Model 2080 Electronic Thermometer, Y (1986) Summary page 1.

## Indications for use
The devices are intended to be used in a clinical setting, physicians' offices or other alternate care settings. The devices are reusable and are intended for the quantitative detection of body temperature, which can be obtained orally, under the arm (axially) or rectally by trained medical personnel.

Source page: https://510kreport.com/device/K070342
Methodology: https://510kreport.com/methodology