# K063759: Heatmarker Time Temperature Indicator

- Pathway: 510(k) (Traditional)
- Applicant: Temptime Corporation
- Decided: Aug 15, 2007 after 239 days
- Product code: OCI (Indicator, Physical/Chemical, Storage Temperature)
- Device class: 2
- Regulation: 21 CFR 880.2800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) SteriTec Dry Heat Indicator Labels: named in the summary without a submission number

## Indications for use
When affixed to a medical device by a health care provider (user), the HEATmarkerTM Time-Temperature Indicator (TTI) is indicated, via a permanent color change, for the purpose of distinguishing between medical devices that have exceeded a selected time-temperature profile of interest to the user from devices that have not exceeded that profile.

Source page: https://510kreport.com/device/K063759
Methodology: https://510kreport.com/methodology