# K991418: Browne Mvi Ethylene Oxide Indicator

- Pathway: 510(k) (Abbreviated)
- Applicant: Albert Browne, Ltd.
- Decided: Jun 10, 1999 after 48 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
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices 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) Gas-Chex® Sterilization Indicator Strips, Propper Mfg. Corp.: named in the summary without a submission number

## Most influential descendants
- K150644: AN85/AN86 EO Indicators (2015), 1 descendant of its own
- K170426: AN85/AN86 EO Indicators (2017), 0 descendants of its own
- K061738: Albert Browne LTD. Verify Steam and EO Load Record Card (2006), 0 descendants of its own

## Indications for use
The Browne MVI Ethylene Oxide Indicator is a process indicator designed to indicate, through a visible color change, when the device has been exposed to an ethylene oxide sterilization process.

Source page: https://510kreport.com/device/K991418
Methodology: https://510kreport.com/methodology