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Steri-Pak Bowie Dick Test Pack

by Steritec Products Mfg Co, Inc.

510(k) K982188

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

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 NumberK982188 Date20 Nov 1998ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-2699-2020 FDA Class II initiated 17 Jun 2020

    The firm received reports from customer that the Regard Migrating Indicator shown malfunctions and does not go into the "accept" window at the time of use.

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  • Withdrawn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, 22 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 Steri-Pak Bowie Dick Test Pack is an indicator, physical/chemical sterilization process device used for monitoring steam sterilizers. It is designed to detect the presence of residual air in pre-vacuum steam sterilizers operating at specified temperatures and cycles as defined in ISO 11140-4.

It is supplied as a disposable test pack for daily monitoring of hospital sterilizers, intended for use in general hospital settings. The device is sterile, single-use, and has received FDA 510(k) clearance under K982188, with product code JOJ and regulation number 880.2800.

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