Propper Eo Line Ethylene Oxide Sterilization Integrator
FDA 510(k) K973585 · Propper Mfg. Co., Inc.
510(k) numberK973585
Submission
- Device name
- Propper Eo Line Ethylene Oxide Sterilization Integrator
- Applicant
- Propper Mfg. Co., Inc.
Long Island, NY, US - Received
- September 22, 1997
- Decision date
- November 6, 1998
- 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 |
|---|---|---|
| K111453 | Steam Dot Blu Process IndicatorJOJ · Abbreviated | 04/05/2012SE |
| K102894 | Classix Chemical Sterilization IndicatorJOJ · Abbreviated | 05/25/2011SE |
| K082620 | Once-A-Day Vertos Test PackJOJ · Abbreviated | 07/08/2009SE |
| K031152 | Propper Vapor Line PCD (Steam Sterilization Process Challenge Test)JOJ · Traditional | 08/17/2004SE |
| K991618 | Bi-O.K. Self-Contained Biological IndicatorFRC · Traditional | 01/24/2001SE |
| K991276 | Pass/Fail Challenge PackJOJ · Traditional | 07/12/1999SE |
| K972747 | Bi-O.K. Eo Gas Biological Test-Pak (269305,269310,269320)FRC · Traditional | 01/09/1998SE |
| K961156 | Once-A-Day Bowie and Dick Test Pack.JOJ · Traditional | 04/01/1997SE |
| K921798 | Propper Super Seracult(R)KHE · Traditional | 10/05/1992SE |
| K915804 | Propper Laryngoscope Blades W Fiber Optic Illum.CCW · Traditional | 03/20/1992SE |
Questions and answers
When was Propper Eo Line Ethylene Oxide Sterilization Integrator cleared by the FDA?
Propper Eo Line Ethylene Oxide Sterilization Integrator (K973585) received a 510(k) decision of Substantially Equivalent on November 6, 1998, 410 days after the submission was received.
What is the product code of K973585?
The FDA product code is JOJ – Indicator, Physical/Chemical Sterilization Process, a Class II (moderate risk) device regulated under 21 CFR 880.2800.