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Evidence Biological Indicator

by Skyland Scientific Services, Inc.

510(k) K910417

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

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

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK910417 Date8 Mar 1991ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FRC
Device Class
Class II
Regulation
21 CFR Part 880.2800
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Evidence Biological Indicator is a biological sterilization process indicator used by health care providers to monitor the adequacy of sterilization procedures. It consists of a known number of microorganisms with a specific resistance to the sterilization mode, contained on a carrier within a protective package.

This device is identified by K910417 and has received FDA 510(k) clearance. It is categorized under regulation number 880.2800 for use in general hospital settings.

Other devices from Skyland Scientific Services, Inc.

Questions

AI-generated answers, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the purpose of the Evidence Biological Indicator?

    This device is designed for use by health care providers to monitor the adequacy of sterilization procedures. It functions by using a known quantity of microorganisms that possess a specific resistance to the sterilization process, allowing clinicians to verify that the sterilization cycle was effective.

  • How is the indicator constructed?

    The device consists of a carrier containing a specific number of microorganisms with defined resistance characteristics. These are housed within a protective package to ensure the integrity of the indicator during the sterilization process.

  • What is the regulatory status of this device?

    The Evidence Biological Indicator has received FDA 510(k) clearance under K910417. It is classified as a Class 2 device under regulation number 880.2800 for use in general hospital settings.