# K962070: Ysi 400 Series Atuoclavable Reusable Temperature Probe

- Pathway: 510(k) (Traditional)
- Applicant: Yellow Springs Instrument Co., Inc.
- Decided: Jul 19, 1996 after 52 days
- Product code: FLL (Continuous Measurement Thermometer)
- Device class: 2
- Regulation: 21 CFR 880.2910
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
15 later devices descend from it; 2 cite it directly.
0 of 16 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
- K050837: Reusable Temperature Probes (M1024254 Skin Temperature Probe, Reusable; M1024247, GP Temperature Probe, Adult, Resuable (2005), 14 descendants of its own
- K121427: Unimed Temperature Probe (2012), 8 descendants of its own
- 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

## Recalls of this device
- Feb 7, 2022 · Class II · Z-0926-2022: Update to instructions for use regarding the cleaning and disinfection process for the reusable probes.
- Mar 13, 2017 · Class II · Z-0395-2018: The reusable temperature probes are provided with instructions for sterilization that have not been proven through a validation study.

Source page: https://510kreport.com/device/K962070
Methodology: https://510kreport.com/methodology