# K053479: Verify Dry Heat Label

- Pathway: 510(k) (Traditional)
- Applicant: Albert Browne, Ltd.
- Decided: Jul 18, 2006 after 216 days
- Product code: JOJ (Indicator, Physical/Chemical Sterilization Process)
- 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
Longest line of descent: 1 generation back to K890758 (1989). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K890758: Dry Heat Sterilization Indicator Tape, Spsmedical Supply Corp. (1989) Summary page 1.

## Indications for use
The Verify® Dry Heat Label is a process indicator that undergoes a visual color change from amber to black when exposed to dry heat in a temperature range of 160°C to 180°C.

Source page: https://510kreport.com/device/K053479
Methodology: https://510kreport.com/methodology