# K032801: Modified Browne Packaging and Label Steam Process Indicator

- Pathway: 510(k) (Special)
- Applicant: Albert Browne, Ltd.
- Decided: Oct 17, 2003 after 38 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: 2 generations back to K932129 (1994). 2 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992767: Browne Packaging and Label Steam Process Indicator, Albert Browne, Ltd. (2000) Summary page 1.

## Most influential descendants
- K073683: Verify Challenge Packs - Version 2 (2008), 2 descendants of its own
- K060103: Albert Browne LTD. Verify Steam Value Indicators (2006), 2 descendants of its own
- K103053: Verify 270FP Challenge Pack (2011), 1 descendant of its own
- K162758: VERIFY SixCess Steam Indicators, VERIFY SixCess Flash Indicators, VERIFY Bowie Dick Test Pack, VERIFY SixCess Challenge Pack, VERIFY SixCess FP Challenge Pack (2017), 0 descendants of its own
- K112256: Steris Steam PI (2012), 0 descendants of its own

## Indications for use
The Modified Browne Packaging and Label Steam Process Indicator is a process indicator which undergoes a visual color change when exposed to steam in a temperature range of 121°C to 135°C (250°F to 275°F).

Source page: https://510kreport.com/device/K032801
Methodology: https://510kreport.com/methodology