# K060649: Genius 2 Infrared Tympanic Electronic Thermometer, Model 303000

- Pathway: 510(k) (Traditional)
- Applicant: Tyco Healthcare Group LP
- Decided: May 22, 2006 after 70 days
- Product code: FLL (Continuous Measurement Thermometer)
- Device class: 2
- Regulation: 21 CFR 880.2910
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K920713 (1992). 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)
- K920713: Firsttemp Genius, Intelligent Medical Systems (1992) Summary page 1.

## Most influential descendants
- K152659: V10 (2016), 2 descendants of its own
- K170497: V10 (2017), 1 descendant of its own
- K200434: V20, V20a, AVSM3 SNF (2020), 0 descendants of its own

## Recalls of this device
- Oct 28, 2019 · Class II · Z-0992-2020: The frequency of calibration for the Genius Tympanic Thermometer as stated in the operating manual may not ensure that thermometers always remain within the stated accuracy range ( 0.2C for Genius 2 a
- Oct 28, 2019 · Class II · Z-0990-2020: The frequency of calibration for the Genius Tympanic Thermometer as stated in the operating manual may not ensure that thermometers always remain within the stated accuracy range ( 0.2C for Genius 2 a
- Oct 28, 2019 · Class II · Z-0991-2020: The frequency of calibration for the Genius Tympanic Thermometer as stated in the operating manual may not ensure that thermometers always remain within the stated accuracy range ( 0.2C for Genius 2 a
- Oct 28, 2019 · Class II · Z-0993-2020: The frequency of calibration for the Genius Tympanic Thermometer as stated in the operating manual may not ensure that thermometers always remain within the stated accuracy range ( 0.2C for Genius 2 a
- Oct 28, 2019 · Class II · Z-0994-2020: The frequency of calibration for the Genius Tympanic Thermometer as stated in the operating manual may not ensure that thermometers always remain within the stated accuracy range ( 0.2C for Genius 2 a

## Indications for use
The Kendall Genius 2 Infrared Tympanic Electronic Thermometer is intended for use in patients in Acute and Alternate care settings to provide temperature measurements from the tympanic membrane and equivalent measurements of oral, core, rectal, and axillary temperature based on the tympanic reading.

Source page: https://510kreport.com/device/K060649
Methodology: https://510kreport.com/methodology