Type 5 Integrating Indicator for Steam (CSPN-15)
FDA 510(k) K242860 · True Indicating, LLC
510(k) numberK242860
Submission
- Device name
- Type 5 Integrating Indicator for Steam (CSPN-15)
- Applicant
- True Indicating, LLC
Toledo, OH, US - Received
- September 20, 2024
- Decision date
- January 17, 2025
- 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 |
| 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 |
| K241836 | Kem Medical Lead-free Chemical Indicators for Steam SterilizationJOJ · Traditional | Kem Medical Products Corporation | 09/30/2024SE |
More from Kem Medical Products Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K251559 | InstaTRU Instant Biological Indicator for Steam (IBI-05)QVB · Traditional | 06/18/2026SE |
| K233413 | Ultraphon Chemical Indicator (TRO-T and TRO-B)JOJ · Traditional | 06/26/2024SE |
| K220778 | Chemical Indicator for SteamJOJ · Traditional | 12/02/2022SE |
| K210481 | Instant 20s IndicatorMTC · Traditional | 12/14/2021SE |
| K200970 | Self-Contained Biological IndicatorFRC · Traditional | 12/28/2020SE |
Questions and answers
When was Type 5 Integrating Indicator for Steam (CSPN-15) cleared by the FDA?
Type 5 Integrating Indicator for Steam (CSPN-15) (K242860) received a 510(k) decision of Substantially Equivalent on January 17, 2025, 119 days after the submission was received.
What is the product code of K242860?
The FDA product code is JOJ – Indicator, Physical/Chemical Sterilization Process, a Class II (moderate risk) device regulated under 21 CFR 880.2800.