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Green Card Bowie-Dick Test (BD115)

by Steritec Products, Inc. (A Getinge Company)

510(k) K250172

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 · Special NumberK250172 Date20 Feb 2025ClearedStatusActive

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  • Withdrawn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
JOJ
Device Class
Class II
Regulation
21 CFR Part 880.2800
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

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

The Green Card Bowie-Dick Test (BD115) is an indicator for physical and chemical sterilization processes. It is designed to detect the presence of residual air in vacuum-assisted steam sterilizers to monitor effective air removal and steam penetration.

This device is intended for use in pre-vacuum steam sterilizers operating at 270°F (132°C) and 273°F (134°C) for 3.5 minutes. It is a lead-free, recordable test card that provides a permanent record of the mechanical function of the sterilizer. The device is authorized under FDA 510(k) clearance.

Questions

AI-generated answers, 6 Oct 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 Green Card Bowie-Dick Test?

    The Green Card Bowie-Dick Test is designed to detect the presence of residual air in vacuum-assisted steam sterilizers. By monitoring for effective air removal and steam penetration, it ensures the mechanical function of the sterilizer is operating correctly.

  • In which types of sterilizers can this device be used?

    This test is specifically intended for use in pre-vacuum steam sterilizers. It must be operated at temperatures of 270°F (132°C) or 273°F (134°C) for a cycle duration of 3.5 minutes.

  • How does the device record sterilization results?

    The Green Card is a lead-free, recordable test card. It is designed to provide a permanent record of the sterilizer's mechanical performance, allowing for documentation of the sterilization process.

  • What is the regulatory status of this test card?

    The Green Card Bowie-Dick Test (BD115) is authorized under FDA 510(k) clearance, ensuring it meets the regulatory requirements for indicators used in physical and chemical sterilization processes.