3M Attest 1491 Super Rapid Readout Biological Indicator; 3M Attest 490 Auto-Reader

510(k) K103277

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 closed

Documents

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK103277	Date19 Apr 2011Cleared	StatusActive

1 recall · FDA

- Terminated Z-2002-2014 FDA Class II initiated 9 Jun 2014
Labeling on units shipped prior to May 16th, 2014 did not contain the statement "This product contains dry natural rubber" as required by the United States Food and Drug Administration (FDA) for medical devices. The non-slip pads at the bottom of the unit contain dry natural rubber. One incident of an allergic reaction in a sensitized individual has been reported.

1 jurisdiction

United States — FDA 510(k) Active

510(k)

510(k) Number: K103277
FDA Product Code: FRC
Models / Variants: 3M Attest 1491 Super Rapid Readout Biological Indicator
3M Attest 490 Auto-Reader