# K071977: Tarry Medical Temperature Probes

- Pathway: 510(k) (Traditional)
- Applicant: Tarry Medical Products, Inc.
- Decided: May 23, 2008 after 311 days
- Product code: FMZ (Incubator, Neonatal)
- Device class: 2
- Regulation: 21 CFR 880.5400
- 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 K950422 (1997). 6 ancestors in all.
No later device cites it as a predicate yet.
1 of 7 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974349: Ohmeda-Ohio Care Plus Incubator, Ohmeda Medical (1998) Summary page 2.
- K001242: Isolette Infant Incubator, Model C2HS, Hill-Rom Air-Shields (2000)
- K960980: Isolette Infant Incubator, Air-Shields, Inc. (1996) Summary page 2.
- K020219: Rpi Skin or Air Temperature Probe, Replacement Parts Industries, Inc. (2002) Summary page 2.

## Indications for use
The Tarry Medical Temperature Probes are designed to be used as replacement temperature sensing probes for use with infant radiant warmers and infant incubators. The probes provide skin or air temperature feedback in order to maintain pre-selected temperature settings.

Source page: https://510kreport.com/device/K071977
Methodology: https://510kreport.com/methodology