# K811862: HI-LO Temp Esophageal Stethoscope

- Pathway: 510(k) (Traditional)
- Applicant: Mallinckrodt Critical Care
- Decided: Jul 10, 1981 after 9 days
- Product code: BZT (Stethoscope, Esophageal, With Electrical Conductors)
- Device class: 2
- Regulation: 21 CFR 868.1920
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K251025: Mon-a-Therm™ Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049) (2025), 0 descendants of its own

Source page: https://510kreport.com/device/K811862
Methodology: https://510kreport.com/methodology