Ati Ethylene Oxide Sterilization Indicator
FDA 510(k) K952995 · Pymah Corp.
510(k) numberK952995
Submission
- Device name
- Ati Ethylene Oxide Sterilization Indicator
- Applicant
- Pymah Corp.
Flemington, NJ, US - Received
- June 28, 1995
- Decision date
- February 22, 1996
- 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
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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 |
More from Steritec Products Mfg. (A Getinge Group Company)
| 510(k) | Device | Decision |
|---|---|---|
| K952408 | Ati Disposable Test Pack for Steam SterilizationJOJ · Traditional | 07/06/1995SE |
| K951063 | Ati Disposable Test Pack for Eo Gas SterilizationJOJ · Traditional | 05/10/1995SE |
| K934874 | Sterigage Eo 100%JOJ · Traditional | 04/18/1995SE |
| K943081 | Trimline 2000DXN · Traditional | 01/27/1995SE |
| K925745 | Ati(R) Disp Biological-Plus Test PackFRC · Traditional | 02/01/1994SE |
| K925496 | Ati Disposable Biological-Plus Test PackFRC · Traditional | 02/01/1994SE |
| K934180 | Slimline 3000DXQ · Traditional | 11/24/1993SE |
| K924681 | Glutaraldehyde MonitorsJOJ · Traditional | 11/17/1993SE |
| K925744 | Tempa-Kuff Single Pat Pre-Gaged Balanced Disp CuffDXQ · Traditional | 07/30/1993SE |
| K930604 | Balanced(Tm) Nylon BladderDXQ · Traditional | 04/30/1993SE |
Questions and answers
When was Ati Ethylene Oxide Sterilization Indicator cleared by the FDA?
Ati Ethylene Oxide Sterilization Indicator (K952995) received a 510(k) decision of Substantially Equivalent on February 22, 1996, 239 days after the submission was received.
What is the product code of K952995?
The FDA product code is JOJ – Indicator, Physical/Chemical Sterilization Process, a Class II (moderate risk) device regulated under 21 CFR 880.2800.