FDA 510(k)

3M Attest Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD (1295PCD)

K-Number: K241542 · 2024-06-27

Decision Date2024-06-27

Product CodeFRC

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

3M Attest Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD (1295PCD) is a medical device manufactured by 3M Company. It received FDA 510(k) clearance on 2024-06-27 under approval number K241542. The device is classified under product code FRC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 3M Attest Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD (1295PCD)?

3M Attest Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD (1295PCD) is a medical device that received FDA 510(k) clearance on 2024-06-27. It is manufactured by 3M Company. The 510(k) number is K241542.

When was 3M Attest Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD (1295PCD) approved by the FDA?

3M Attest Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD (1295PCD) received FDA 510(k) clearance on 2024-06-27, under approval number K241542.

What company makes 3M Attest Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD (1295PCD)?

3M Attest Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD (1295PCD) is manufactured by 3M Company.

What is the FDA product code for 3M Attest Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD (1295PCD)?

The FDA product code for 3M Attest Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD (1295PCD) is FRC.

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Related PubMed Literature

PMID: 41815749 The history of state preemption and medical device regulation: lessons for artificial intelligence oversight. Health affairs scholar (2026) PMID: 40574446 [Research on Classification of Medical Devices with Nanomaterials]. Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation (2025) PMID: 40237623 Diffusion of Hydrogen Peroxide Through Medical Grade Poly(Ether)urethane: Analyzing Mechanisms of Sorption and Transport to Support Sterilization With Vapor Phase Hydrogen Peroxide. Journal of biomedical materials research. Part B, Applied biomaterials (2025)

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Related Devices (Code: FRC)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.