# K061738: Albert Browne LTD. Verify Steam and EO Load Record Card

- Pathway: 510(k) (Traditional)
- Applicant: Albert Browne, Ltd.
- Decided: Aug 25, 2006 after 66 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: 4 generations back to K932129 (1994). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991418: Browne Mvi Ethylene Oxide Indicator, Albert Browne, Ltd. (1999) Summary page 1.
- K060103: Albert Browne LTD. Verify Steam Value Indicators, Albert Browne, Ltd. (2006) Summary page 1.
- K000502: Steam/EO Record Card, Model CI 121, Steritec Products Mfg Co, Inc. (2000) Summary page 1.

## Indications for use
The Albert Browne Ltd. VERIFY® STEAM and EO Load Record Card are process indicators that undergo a visual color change when exposed to steam in a temperature range of 121°C to 135°C (250°F to 275°F) or an ethylene oxide sterilization process.

Source page: https://510kreport.com/device/K061738
Methodology: https://510kreport.com/methodology