Steam Sterilization Intergrator
FDA 510(k) K012195 · Dana Products, Inc.
510(k) numberK012195
Submission
- Device name
- Steam Sterilization Intergrator
- Applicant
- Dana Products, Inc.
South Barrington, IL, US - Received
- July 13, 2001
- Decision date
- May 7, 2002
- 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 |
| 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 |
| K092944 | Dana Reusable Test Pack for Steam SterilizationFRC · Traditional | 03/18/2010SE |
Questions and answers
When was Steam Sterilization Intergrator cleared by the FDA?
Steam Sterilization Intergrator (K012195) received a 510(k) decision of Substantially Equivalent on May 7, 2002, 298 days after the submission was received.
What is the product code of K012195?
The FDA product code is JOJ – Indicator, Physical/Chemical Sterilization Process, a Class II (moderate risk) device regulated under 21 CFR 880.2800.