# K121427: Unimed Temperature Probe

- Pathway: 510(k) (Traditional)
- Applicant: Unimed Medical Supplies, Inc.
- Decided: May 29, 2012 after 15 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). 2 ancestors in all.
8 later devices descend from it; 7 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962070: Ysi 400 Series Atuoclavable Reusable Temperature Probe, Yellow Springs Instrument Co., Inc. (1996) Summary page 2.
- K050837: Reusable Temperature Probes (M1024254 Skin Temperature Probe, Reusable; M1024247, GP Temperature Probe, Adult, Resuable, GE Healthcare (2005) Summary page 2.

## Most influential descendants
- K193338: Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes (2020), 1 descendant of its own
- K253162: Temperature probes (T2252-PG); Temperature probes (TCMA-AG); Temperature probes (TCMA-PG); Temperature probes (TMQ-DAG); Temperature probes (THP-DAG) (2026), 0 descendants of its own
- K243000: Reusable Temperature Probe (T1306, T2306, T3306, T4306);  Disposable Temperature Probe (T5106, T6106) (2025), 0 descendants of its own
- K223807: Reusable Temperature Probe, Disposable Temperature Probe (2023), 0 descendants of its own
- K203636: PlusCare Temperature Probes, Skin Types: PT2252-AS, PTHP-AS, PTMQ-AS, PTSW-AS, PTSM-15AS, PTSL-AS, PTMR-AS; Rectum Types: PT2252-AG, PTHP-AG, PTMQ-AG, PTSW-AG, PTSM-15AG, PTSL-AG, PTMR-AG (2021), 0 descendants of its own

## Indications for use
Unimed Temperature Probes are intended to be used for monitoring temperature. The temperature probes are reusable and designed for use with monitors of Philips, Marquette, Mindray, Spacelabs, Siemens, Artema/S&W and other monitors compatible with YSI 400 series temperature probes. These devices are indicated for used by qualified medical personnel only.

Source page: https://510kreport.com/device/K121427
Methodology: https://510kreport.com/methodology