3M Attest 290 Auto-Reader
FDA 510(k)Class II (US FDA 510(k))
by 3m Company
Identifiers
- 510(k) Number
- K004009 FDA 510(k)
- FDA Product Code
- FRC 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)
The 3M Attest 290 Auto-Reader is a biological indicator reader designed for automated detection of sterilization process validation. It functions as an indicator for biological sterilization processes, specifically for steam sterilization, by reading and interpreting results from biological indicators to confirm effective sterilization cycles.
This device is intended for use in hospital settings, where it operates as a standalone unit to automatically read and process biological indicators. Supplied as a reusable medical device, it complies with IEC/EN 61010-1 safety standards and has received FDA 510(k) clearance under the General Hospital advisory committee. The device is classified as Class II and is regulated under FDA regulation number 880.2800.
Frequently asked questions
What is the primary purpose of the 3M Attest 290 Auto-Reader in a hospital setting?
The 3M Attest 290 Auto-Reader is designed to automate the detection and validation of steam sterilization processes. It reads and interprets biological indicators to confirm whether sterilization cycles have been effectively completed, ensuring that medical instruments and supplies are properly sterilized before use.
Is the 3M Attest 290 Auto-Reader a single-use or reusable device, and how should it be maintained?
The 3M Attest 290 Auto-Reader is a reusable medical device, meaning it is built to be used repeatedly in hospital settings. While the device itself is not disposable, the biological indicators it reads are single-use consumables. Maintenance details are not specified, but its compliance with IEC/EN 61010-1 safety standards suggests it is designed for reliable, long-term use with proper care.
What regulatory pathway was followed for FDA clearance of the 3M Attest 290 Auto-Reader?
The 3M Attest 290 Auto-Reader received FDA 510(k) clearance under the General Hospital advisory committee (HO) through a traditional review process. It was determined to be substantially equivalent to a predicate device, and the clearance was granted on March 25, 2002, with the 510(k) number K004009. The device is classified as Class II and regulated under FDA regulation number 880.2800.
How is the 3M Attest 290 Auto-Reader intended to be used in relation to biological indicators?
The device operates as a standalone unit that automatically reads and processes biological indicators used in steam sterilization processes. These indicators are placed in sterilization loads to confirm the effectiveness of the sterilization cycle. The Attest 290 interprets the results from these indicators, providing validation that the sterilization process met required standards.
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: 3M ATTEST 290 OPERATOR'S MANUAL Pdf Download | ManualsLib, PDF 3M Attest 290 Auto-reader, PDF 3M Attest 290 Auto-reader Operators Manual.pdf - iFixit, 3M Attest 290 Auto-reader Operator's Manual, 3M Attest 290 Auto reader Operators Manual - Archive.org
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K004009 | Class II | Active |
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Manufacturer
- Manufacturer
- 3m Company
Sources (1)
- FDA 510(k) K004009 24 fields · synced Sep 19, 2026