Browne Packaging and Label Steam Process Indicator
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K992767 FDA 510(k)
- FDA Product Code
- JOJ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.2800 FDA 510(k)
- Regulation Number
- 880.2800 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
This device is a Physical/Chemical Sterilization Process Indicator designed to verify exposure to steam sterilization. It visually confirms whether packaging or labels have been subjected to steam sterilization within a temperature range of 121°C to 134°C (250°F to 273°F), ensuring process validation in medical or healthcare settings.
The indicator is supplied as a single-use, non-sterile component intended for use in steam autoclaves. It adheres to ANSI/AAMI ST60 standards for Class I steam sterilization indicators and is regulated under FDA 510(k) clearance (K992767). No MRI safety or reusable specifications are noted, and storage conditions are not specified in the regulatory data.
Frequently asked questions
What is the Browne Packaging and Label Steam Process Indicator used for?
This device visually confirms whether packaging or labels have been properly exposed to steam sterilization within the temperature range of 121°C to 134°C (250°F to 273°F). It ensures process validation in healthcare settings, helping to guarantee that materials intended for sterile use have undergone the correct sterilization cycle.
Is the Browne Steam Process Indicator sterile or non-sterile?
The indicator is supplied as a non-sterile component. It is designed for single-use in steam autoclaves and is not intended to be sterile before or after use. Its purpose is to verify sterilization exposure, not to serve as a sterile barrier.
Can the Browne Steam Process Indicator be reused?
No, the indicator is explicitly designed for single-use only. After exposure to steam sterilization, it changes state to confirm the process, but it is not intended or tested for reuse. Discard it following a single sterilization cycle.
What temperature range does the Browne Steam Process Indicator validate?
The indicator verifies steam sterilization exposure within a temperature range of 121°C to 134°C (250°F to 273°F). This range aligns with standard steam sterilization protocols for medical or healthcare packaging, ensuring accurate validation of the sterilization process.
Are there any specific storage requirements for the Browne Steam Process Indicator?
The regulatory data does not specify storage conditions for the Browne Steam Process Indicator. However, as a single-use, non-sterile component, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures to preserve its integrity until use.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Browne Packaging and Label Steam Process Indicator, Modified Browne Packaging and Label Steam Process Indicator, BROWNE STEAM INDICATOR by BOARD OF DIRECTORS, ALBERT BROWNE LTD. | FDA ..., BROWNE PACKAGING AND LABEL STEAM PROCESS INDICATOR… - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K992767 | Class II | Active |
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Manufacturer
- Manufacturer
- Albert Browne , Ltd.
Sources (1)
- FDA 510(k) K992767 24 fields · synced Oct 1, 2026