# K121999: General Purpose Temperature Probe, Skin Temperature Probe

- Pathway: 510(k) (Traditional)
- Applicant: Draeger Medical GmbH
- Decided: Feb 28, 2013 after 234 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
Longest line of descent: 2 generations back to K962070 (1996). 7 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K946306: Siemens SC 9000 Bedside Monitor, SC 9015 Bedside Mointoring System, Siemens Medical Solutions USA, Inc. (1995) Summary page 2.
- K050837: Reusable Temperature Probes (M1024254 Skin Temperature Probe, Reusable; M1024247, GP Temperature Probe, Adult, Resuable, GE Healthcare (2005) Summary page 2.
- K051873: Disposable Temperature, Skin and Esophageal Probes, GE Healthcare (2005) Summary page 2.
- (no number) Disposable temperature probes/sensors: named in the summary without a submission number
- (no number) Instrument cables: named in the summary without a submission number

## Most influential descendants
- 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
- K193625: Disposable Temperature Probe (2020), 0 descendants of its own

## Indications for use
General Purpose Temperature probes Driger disposable general purpose temperature probes are intended for patient core body temperature measurement in combination with Driger and Siemens patient monitoring systems. The probes are inserted into the oesophagus or the rectum. Skin Temperature probes Driger disposable skin temperature probes are intended for patient skin temperature measurement in combination with Driger and Siemens patient monitoring systems. The probes are affixed on the patients skin with an adhesive cover.

Source page: https://510kreport.com/device/K121999
Methodology: https://510kreport.com/methodology