# K922344: Omron Tympanic Thermometer MC-500

- Pathway: 510(k) (Traditional)
- Applicant: Omron Healthcare, Inc.
- Decided: Jun 29, 1993 after 406 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.
4 later devices descend from it; 4 cite 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)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K023412: Thermo Buddy, Models TB-100, TB-110, TB-120 (2003), 0 descendants of its own
- K021753: E-Care Infared Ear Thermometer, Model LCT-200 (2002), 0 descendants of its own
- K020520: Easytem Ear Thermometer, Model BT-020 (2002), 0 descendants of its own
- K984497: Temp Teller-Infrared Tympanic Thermometer, Models TT-200, TT-201 (1999), 0 descendants of its own

Source page: https://510kreport.com/device/K922344
Methodology: https://510kreport.com/methodology