Steam-Dot Process Indicator
FDA 510(k) K210553 · Propper Manufacturing Co., Inc.
510(k) numberK210553
Submission
- Device name
- Steam-Dot Process Indicator
- Applicant
- Propper Manufacturing Co., Inc.
Long Island, NY, US - Received
- February 25, 2021
- Decision date
- May 19, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 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 |
|---|---|---|
| K250306 | Chex-All Sterilization Pouches and TubesFRG · Abbreviated | 10/31/2025SE |
| K240910 | EO Chex Indicator TapeJOJ · Abbreviated | 06/12/2024SE |
| K222137 | OK Plus IndicatorJOJ · Abbreviated | 12/05/2022SE |
| K212592 | Gas-Chex IndicatorJOJ · Abbreviated | 01/20/2022SE |
| K210866 | Steri-Dot Process IndicatorJOJ · Abbreviated | 06/21/2021SE |
| K141638 | Propper Insight Binocular Indirect OphthalmosopeHLI · Abbreviated | 09/17/2014SE |
Questions and answers
When was Steam-Dot Process Indicator cleared by the FDA?
Steam-Dot Process Indicator (K210553) received a 510(k) decision of Substantially Equivalent on May 19, 2021, 83 days after the submission was received.
What is the product code of K210553?
The FDA product code is JOJ – Indicator, Physical/Chemical Sterilization Process, a Class II (moderate risk) device regulated under 21 CFR 880.2800.