3M™ Attest™ Super Rapid Readout Biological Indicator 1493 +4 more models

FDA 510(k)

Class II (US FDA 510(k))

510(k) K242538

Identifiers

510(k) Number: K242538 FDA 510(k)
FDA Product Code: FRC FDA 510(k)
Models / Variants: 3M™ Attest™ Super Rapid Readout Biological Indicator 1493 FDA 510(k)
3M™ Attest™ Super Rapid Steam Gravity Clear Challenge Pack 1493PCDG FDA 510(k)
3M™ Attest™ Auto-reader 490 FDA 510(k)
3M™ Attest™ Auto-reader 490H FDA 510(k)
3M™ Attest™ Mini Auto-reader 490M 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 Super Rapid Readout Biological Indicator 1493 is a biological indicator used to monitor steam sterilization cycles. It is designed to work with the 3M Attest Auto-reader 490, 3M Attest Auto-reader 490H, and 3M Attest Mini Auto-reader 490M. The device is used to monitor 250°F (121°C) 30-minute gravity and 15-, 20-, 30- or 35-minute dynamic-air-removal saturated steam sterilization processes.

The device is supplied with various components, including the 3M Attest Super Rapid Steam Gravity Clear Challenge Pack 1493PCDG. It is intended for use in general hospital settings and is regulated under the product code FRC. The device has been authorized with an FDA 510K clearance and is classified as a class 2 device.

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™ Super Rapid Readout Biological Indicator 1493/1493P, 3M™ Attest™ Super Rapid Biological Indicator 1493 / 1493P, 3M™ Attest™ Super Rapid Readout Biological Indicator 1493/1493P

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K242538	Class II	Active

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Manufacturer

Manufacturer: 3m Company

Sources (1)

FDA 510(k) K242538 24 fields · synced Sep 24, 2026