Rapicide PA High-Level Disinfectant Test Strips
FDA 510(k) K152394 · Medivators, Inc.
510(k) numberK152394
Submission
- Device name
- Rapicide PA High-Level Disinfectant Test Strips
- Applicant
- Medivators, Inc.
Minneapolis, MN, US - Received
- August 24, 2015
- Decision date
- March 11, 2016
- 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
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|---|---|---|---|
| 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 |
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| K151522 | DEFENDO Bronchoscopy Suction ValveKTI · Traditional | 09/17/2015SE |
| K133724 | Minncare HDNIH · Traditional | 08/27/2014SE |
| K140753 | Endo Smart Bottle, Rinse and Insufflation SystemOCX · Special | 07/15/2014SE |
| K993042 | Medivators 5 Minute High-Level DisinfectantMED · Traditional | 08/17/2000SE |
Questions and answers
When was Rapicide PA High-Level Disinfectant Test Strips cleared by the FDA?
Rapicide PA High-Level Disinfectant Test Strips (K152394) received a 510(k) decision of Substantially Equivalent on March 11, 2016, 200 days after the submission was received.
What is the product code of K152394?
The FDA product code is JOJ – Indicator, Physical/Chemical Sterilization Process, a Class II (moderate risk) device regulated under 21 CFR 880.2800.