Dana Reusable Bowie Test Pack for Dana Bowie Dick Indicators
FDA 510(k) K120592 · Dana Products, Inc.
510(k) numberK120592
Submission
- Device name
- Dana Reusable Bowie Test Pack for Dana Bowie Dick Indicators
- Applicant
- Dana Products, Inc.
South Barrington, IL, US - Received
- February 28, 2012
- Decision date
- February 27, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JOJ – Indicator, Physical/Chemical Sterilization Process
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.2800
- Specialty
- General Hospital
Other 510(k)s with product code JOJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260181 | LF Process Indicator Tape for Steam SterilizationJOJ · Special | Intertape Polymer Group | 02/20/2026SE |
| K251991 | SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016); SafeSecure…JOJ · Traditional | Shenzhen Safesecure Medical Infection Control… | 12/23/2025SE |
| K251035 | DISINTEK PA Test StripsJOJ · Traditional | Serim Research | 06/03/2025SE |
| K251048 | Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118JOJ · Special | STERIS Corporation | 05/02/2025SE |
| K243876 | VERIFY STEAM Integrating IndicatorJOJ · Special | STERIS Corporation | 04/25/2025SE |
| K250172 | Green Card Bowie-Dick Test (BD115)JOJ · Special | Steritec Products, Inc. (A Getinge Company) | 02/20/2025SE |
| K242860 | Type 5 Integrating Indicator for Steam (CSPN-15)JOJ · Traditional | True Indicating, LLC | 01/17/2025SE |
| K241036 | Autoclave Indicator Tape; EO Indicator TapeJOJ · Traditional | Jiangmen New Era External Use Drug Co., Ltd. | 12/17/2024SE |
| K243475 | Chemical Indicator for enspire CLCSPS (LCC015)JOJ · Special | STERIS Corporation | 12/04/2024SE |
| K242795 | Getinge Assured MI Steam Migrating IntegratorJOJ · Special | Steritec Products Mfg. (A Getinge Group Company) | 10/15/2024SE |
More from Steritec Products Mfg. (A Getinge Group Company)
| 510(k) | Device | Decision |
|---|---|---|
| K133267 | Dana Reusable Test PackFRC · Traditional | 02/11/2014SE |
| K130135 | Dana Reusable Bi Test PackJOJ · Traditional | 11/25/2013SE |
| 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 |
| K092944 | Dana Reusable Test Pack for Steam SterilizationFRC · Traditional | 03/18/2010SE |
| K012195 | Steam Sterilization IntergratorJOJ · Traditional | 05/07/2002SE |
Questions and answers
When was Dana Reusable Bowie Test Pack for Dana Bowie Dick Indicators cleared by the FDA?
Dana Reusable Bowie Test Pack for Dana Bowie Dick Indicators (K120592) received a 510(k) decision of Substantially Equivalent on February 27, 2013, 365 days after the submission was received.
What is the product code of K120592?
The FDA product code is JOJ – Indicator, Physical/Chemical Sterilization Process, a Class II (moderate risk) device regulated under 21 CFR 880.2800.