3M Attest Steam Chemical Integrators
FDA 510(k)Class II (US FDA 510(k))
by 3m Company
Identifiers
- 510(k) Number
- K191236 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)
The device is an Indicator, Physical/Chemical Sterilization Process, classified as a Type 5 Integrating Indicator under ISO 11140-1:2014. It is designed to determine whether the process conditions necessary for sterilization were met inside each pack.
It is supplied in configurations such as 1243A/1243B, with dimensions of 3/4 in x 2 in (1.9 cm x 5.1 cm), packaged as 100/BAG, 10 BAG/CS, 1000/CS. The device has received FDA 510(k) clearance under K191236 and is regulated under regulation number 880.2800 with product code JOJ.
Frequently asked questions
What is the 3M Attest Steam Chemical Integrator used for?
The 3M Attest Steam Chemical Integrator is used to determine whether the process conditions necessary for sterilization were met inside each pack, functioning as a Type 5 integrating indicator under ISO 11140-1:2014 to assess steam sterilization efficacy.
How is the 3M Attest Steam Chemical Integrator supplied and packaged?
The device is supplied in configurations such as 1243A/1243B, with dimensions of 3/4 in x 2 in (1.9 cm x 5.1 cm), packaged as 100 per bag, 10 bags per case, and 1000 per case for convenient use in healthcare settings.
Is the 3M Attest Steam Chemical Integrator reusable or single-use?
The 3M Attest Steam Chemical Integrator is a single-use device designed for one-time exposure to the sterilization process; it cannot be reused as its chemical indicators undergo an irreversible change upon exposure to sterilizing conditions.
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™ Steam Chemical Integrator - solventum.com, 3M Chemical Integrators for Health Care | 3M United States, 3M Sterilization & Monitoring | 3M United States, 3MTM AttestTM Steam Chemical Integrator
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K191236 | Class II | Active |
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Manufacturer
- Manufacturer
- 3m Company
Sources (1)
- FDA 510(k) K191236 24 fields · synced Sep 26, 2026