Steamplus Sterilization Test
FDA 510(k) K020409 · Spsmedical Supply Corp.
510(k) numberK020409
Submission
- Device name
- Steamplus Sterilization Test
- Applicant
- Spsmedical Supply Corp.
Rush, NY, US - Received
- February 7, 2002
- Decision date
- July 18, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
|---|---|---|
| K122024 | Spsmedical Sporview 10 Steam Self Contained Biological IndicatorFRC · Traditional | 11/26/2013SE |
| K130211 | Airview Bowie Dick; Test Pack, Indicator SheetsJOJ · Special | 07/05/2013SE |
| K111515 | Spsmedical Sporview Steam BiFRC · Traditional | 02/01/2012SE |
| K110152 | Spsmedical Vaporized Hydrogen Peroxide Chemical IndicatorsJOJ · Traditional | 04/15/2011SE |
| K102363 | Spsmedical Emplus 270 F Steam Emulator Model EMP-104, EMP-1004JOJ · Traditional | 01/27/2011SE |
| K090650 | Spsmedical Vaporized Hydrogen Peroxide Chemical IndicatorsJOJ · Traditional | 10/09/2009SE |
| K081879 | Spsmedical Sporview Pa Culture SetMRB · Special | 07/30/2008SE |
| K070595 | Sporview Steam Self-Contained Biological IndicatorFRC · Traditional | 05/24/2007SE |
| K063799 | Steamplus Steam IntegratorJOJ · Traditional | 01/05/2007SE |
| K051173 | Spsmedical Sporview Plus Steam Bi Test PackFRC · Special | 05/27/2005SE |
Questions and answers
When was Steamplus Sterilization Test cleared by the FDA?
Steamplus Sterilization Test (K020409) received a 510(k) decision of Substantially Equivalent on July 18, 2002, 161 days after the submission was received.
What is the product code of K020409?
The FDA product code is JOJ – Indicator, Physical/Chemical Sterilization Process, a Class II (moderate risk) device regulated under 21 CFR 880.2800.