# K913083: BI-Temp Temperature Monitor TM-201D

- Pathway: 510(k) (Traditional)
- Applicant: Respiratory Support Products, Inc.
- Decided: Oct 17, 1991 after 147 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.
8 later devices descend from it; 1 cites it directly.
0 of 9 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
- K112376: S-Cath Esophageal Temperature Probe and Temperature Monitoring System (2011), 7 descendants of its own
- K123361: Esotest Esophageal Temperature Probe and Temperature Monitoring System (2013), 6 descendants of its own
- K180047: ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System (2018), 3 descendants of its own
- K192210: ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System (2019), 2 descendants of its own
- K200943: Circa S-Cath M Esophageal Temperature Probe and Temperature Monitoring System (2021), 1 descendant of its own

Source page: https://510kreport.com/device/K913083
Methodology: https://510kreport.com/methodology