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ATI Disposable Biological-Plus Test Pack

by Pymah Corp. 510(k)

Active United States

510(k) K925496

Overview

The ATI Disposable Biological-Plus Test Pack is an Indicator, Biological Sterilization Process, designed to monitor the effectiveness of biological indicators in sterilization cycles. It provides visual confirmation of microbial kill within a sterilization process, ensuring compliance with sterilization protocols for medical devices and equipment.

This single-use device is intended for use in general hospital settings and is regulated under FDA regulation 880.2800. Supplied as a disposable pack, it requires no special storage conditions beyond those recommended for sterilization indicators. The device received FDA 510(k) clearance (K925496) in 1994 under a traditional review process, classified as a Class II medical device.

AI-generated from registry data, 19 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK925496 Date1 Feb 1994ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
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  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

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

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Questions

  • What is the primary purpose of the ATI Disposable Biological-Plus Test Pack in a sterilization process?

    The ATI Disposable Biological-Plus Test Pack is designed as a biological indicator to monitor the effectiveness of sterilization cycles. It provides visual confirmation that microbial contamination has been eliminated during the sterilization process, ensuring compliance with sterilization protocols for medical devices and equipment in general hospital settings.

  • How is the ATI Disposable Biological-Plus Test Pack supplied, and is it reusable?

    The device is supplied as a single-use, disposable pack. Since it is intended for one-time use in monitoring sterilization cycles, it is not designed for reuse. This ensures accuracy and reliability in each sterilization process.

  • Are there any special storage requirements for the ATI Disposable Biological-Plus Test Pack?

    No special storage conditions are required beyond those typically recommended for sterilization indicators. The pack can be stored under standard conditions until use, ensuring it remains effective for its intended purpose.

  • What regulatory pathway was followed for FDA clearance of this device, and when was it cleared?

    The ATI Disposable Biological-Plus Test Pack received FDA 510(k) clearance under a traditional review process in 1994. It was classified as a Class II medical device and determined to be substantially equivalent to a predicate device, with clearance granted on February 1, 1994.

  • Is this device applicable only to specific types of sterilization equipment, or can it be used across different sterilization processes?

    While the device is regulated under FDA regulation 880.2800 for general hospital use, it is designed to monitor biological sterilization processes broadly. This means it can be used across various sterilization methods (e.g., steam, ethylene oxide) in general hospital settings, provided the sterilization cycle is compatible with biological indicators.