# K984497: Temp Teller-Infrared Tympanic Thermometer, Models TT-200, TT-201

- Pathway: 510(k) (Traditional)
- Applicant: Oriental System Technology, Inc.
- Decided: May 26, 1999 after 160 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 K902912 (1990). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K902912: Thermoscan-Instant Thermometer Model IR-4000, Thermoscan, Inc. (1990) Summary page 1.
- K930680: Thermoscan Instant Thermometer IR-5000, Thermoscan, Inc. (1994) Summary page 1.
- K954523: Thermoscan Instant Thermometer Model IR-6000, Thermoscan, Inc. (1996) Summary page 1.
- K964605: Braun Thermoscan Pro-2000 Instant Thermometer (Pro-2000), Thermoscan, Inc. (1997) Summary page 1.
- K922344: Omron Tympanic Thermometer MC-500, Omron Healthcare, Inc. (1993) Summary page 1.

## Indications for use
The device is an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in the neonatal, pediatric and adult population used in the home setting.

Source page: https://510kreport.com/device/K984497
Methodology: https://510kreport.com/methodology