3M Attest Rapid Readout Biological Indicator 1295
FDA 510(k)Class II (US FDA 510(k))
by 3m Company
Identifiers
- 510(k) Number
- K152060 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 Rapid Readout Biological Indicator 1295 is a biological sterilization process indicator. It is designed to monitor vaporized hydrogen peroxide sterilization processes and provides results in 24 minutes.
This device is supplied as a biological indicator with a pink cap. It has received FDA 510(k) clearance under the regulation number 880.2800.
Frequently asked questions
What is the primary purpose of the 3M Attest 1295?
This device is a biological sterilization process indicator specifically designed to monitor vaporized hydrogen peroxide sterilization cycles to ensure they are functioning correctly.
How quickly does the 3M Attest 1295 provide results?
The indicator is designed for rapid readout, providing results in 24 minutes, which allows for efficient monitoring of the sterilization process.
How is the 3M Attest 1295 identified in a clinical setting?
The device is supplied as a biological indicator featuring a distinct pink cap, which helps in identifying this specific model during the sterilization monitoring process.
What is the regulatory status of this indicator?
The 3M Attest 1295 has received FDA 510(k) clearance under regulation number 880.2800, confirming it has been reviewed and cleared for use as a biological sterilization process indicator.
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 Biological Indicators for Medical | 3M United States, 3M ATTEST 1295 MANUAL Pdf Download | ManualsLib, 3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide (H₂O₂) Biological ..., 3M Attest 1295 Rapid Readout Biological lndicator
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K152060 | Class II | Active |
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Manufacturer
- Manufacturer
- 3m Company
Sources (1)
- FDA 510(k) K152060 24 fields · synced Sep 27, 2026