# K051873: Disposable Temperature, Skin and Esophageal Probes

- Pathway: 510(k) (Traditional)
- Applicant: GE Healthcare
- Decided: Sep 20, 2005 after 71 days
- Product code: FLL (Continuous Measurement Thermometer)
- Device class: 2
- Regulation: 21 CFR 880.2910
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K925789 (1993). 3 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K925789: Debusk Temp. Syst. Esophageal Stethoscope, Deroyal Industries, Inc. (1993) Summary page 2.
- K925006: Hydro-Temp Nicu and Skin Surface Temperature Senso, Deroyal Industries, Inc. (1994) Summary page 2.
- K925791: Exac-Temp & Clini-Temp Probe W/Temperature Sensor, Deroyal Industries, Inc. (1994) Summary page 2.

## Most influential descendants
- K121999: General Purpose Temperature Probe, Skin Temperature Probe (2013), 5 descendants of its own
- K181967: Disposable Temperature Probe (2018), 2 descendants of its own
- K193338: Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes (2020), 1 descendant of its own
- K182755: Disposable Temperature Probe (2018), 1 descendant of its own
- K223807: Reusable Temperature Probe, Disposable Temperature Probe (2023), 0 descendants of its own

## Recalls of this device
- Jul 18, 2013 · Class II · Z-1959-2013: GE Healthcare has become aware of a potential safety issue associated with the use of GE General Purpose 9 French Temperature Probe, Disposable, 400 Series [M1024229]. GEs Disposable General Purpose 

## Indications for use
GP probes (REF M1024231 and M1024229: The General Purpose Temperature Probe is intended for continuous temperature monitoring. The probe is inserted into the esophagus or the rectum. It is sterile and individually packaged. It has a low-friction surface finish to make the insertion easier. The temperature probe beneath the cuff at the distal tip is designed for use with Datex-Ohmeda and GE Medical Systems IT monitoring systems and other monitors compatible with 400 Series temperature probes. The device is indicated for use by qualified medical personnel only. Skin probe (REF M1024222): The Skin Temperature Probe is intended for monitoring the skin surface temperature. It is sterile and individually packaged. There is a temperature sensor affixed to the center of the foam material on the adhesive cover. The disk-shaped adhesive cover has a reflective backing and a hypo-allergenic adhesive which follows closely the contour of the skin. The skin temperature probe is designed for use with Datex-Ohmeda and GE Medical Systems IT monitoring systems and other monitors compatible with 400 Series temperature probes. The device is indicated for use by qualified medical personnel only. Esophageal probes (REF M1024205. M1024212. M1024215 and M1024218): The Esophageal Stethoscope with Temperature Probe is to be used for monitoring temperature, heart, and respiratory sounds on an anesthetized patient. The stethoscope tube is inserted into the esophagus. The probe is sterile, individually packaged and comes in different sizes. It has a low-friction surface finish to make the insertion easier, and a thin cuff to enhance sound transmission and fidelity. The stethoscope has a male luer fitting for attachment to a standard ear piece. The temperature probe, beneath the cuff at the distal tip, is designed for use with Datex-Ohmeda and GE Medical Systems IT monitoring systems and other monitors compatible with 400 Series temperature probes. The device is indicated for use by qualified medical personnel only.

Source page: https://510kreport.com/device/K051873
Methodology: https://510kreport.com/methodology