Dana Reusable Test Pack for Steam Sterilization
FDA 510(k) K092944 · Dana Products, Inc.
510(k) numberK092944
Submission
- Device name
- Dana Reusable Test Pack for Steam Sterilization
- Applicant
- Dana Products, Inc.
South Barrington, IL, US - Received
- September 24, 2009
- Decision date
- March 18, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FRC – Indicator, Biological Sterilization Process
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.2800
- Specialty
- General Hospital
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| K251452 | Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059)…FRC · Special | Steris | 06/06/2025SE |
| K250061 | Celerity IncubatorFRC · Special | STERIS Corporation | 02/06/2025SE |
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| K242453 | Terragene® Bionova® Photon Process Challenge Device with unique-point integrator…FRC · Traditional | Terragene S.A. | 12/12/2024SE |
| K242538 | 3M Attest Super Rapid Readout Biological Indicator 1493; 3M Attest Super Rapid Steam…FRC · Traditional | 3M Company | 11/25/2024SE |
| K241959 | 3M Attest Super Rapid Steam Clear Challenge Pack (1492PCD); 3M Attest Auto-reader…FRC · Traditional | 3M Company | 10/18/2024SE |
More from 3M Company
| 510(k) | Device | Decision |
|---|---|---|
| K133267 | Dana Reusable Test PackFRC · Traditional | 02/11/2014SE |
| K130135 | Dana Reusable Bi Test PackJOJ · Traditional | 11/25/2013SE |
| K120592 | Dana Reusable Bowie Test Pack for Dana Bowie Dick IndicatorsJOJ · Traditional | 02/27/2013SE |
| K110253 | Reusable Test Pack for Dana Emulating IndicatorsJOJ · Traditional | 04/29/2011SE |
| K103321 | Dana Reusable Testpack for Steam Sterilization for 10 Minute Extended CyclesFRC · Traditional | 02/16/2011SE |
| K100891 | Dana Emulating IndicatorJOJ · Traditional | 01/13/2011SE |
| K102761 | Dana Reusable Test Pack for Steam SterilizationJOJ · Traditional | 12/20/2010SE |
| K012195 | Steam Sterilization IntergratorJOJ · Traditional | 05/07/2002SE |
Questions and answers
When was Dana Reusable Test Pack for Steam Sterilization cleared by the FDA?
Dana Reusable Test Pack for Steam Sterilization (K092944) received a 510(k) decision of Substantially Equivalent on March 18, 2010, 175 days after the submission was received.
What is the product code of K092944?
The FDA product code is FRC – Indicator, Biological Sterilization Process, a Class II (moderate risk) device regulated under 21 CFR 880.2800.