Castle Tec-Test S.M.A.R.T. Pack
FDA 510(k) K833074 · Castle Co.
510(k) numberK833074
Submission
- Device name
- Castle Tec-Test S.M.A.R.T. Pack
- Applicant
- Castle Co.
Mchenry, IL, US - Received
- September 9, 1983
- Decision date
- November 7, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K870975 | Modified Castle PowerclaveFLE · Traditional | 04/17/1987SE |
| K860263 | Castle 7538 Floor Loading WasherLDS · Traditional | 03/05/1986SE |
| K844089 | Castle 7515 Utensil/Glassware WasherLDS · Traditional | 01/14/1985SE |
| K834048 | Bovie Conductive Adhes-Disper-ElectroGEI · Traditional | 04/04/1984SE |
| K831595 | Castle Model 3341 & 3441 & 4141 Gas AerFLI · Traditional | 06/15/1983SE |
| K792660 | 1500 Eo Exhaust HoodFLF · Traditional | 01/29/1980SE |
| K792649 | Unispore-Biological IndicatorsFRC · Traditional | 01/29/1980SE |
| K790677 | Eo Evacuating System IFLI · Traditional | 05/07/1979SE |
| K781887 | 9100 Daystar and 9110 Orbiter PackageFSY · Traditional | 12/12/1978SE |
| K781484 | Castle Model 3146 Gas AeratorFLI · Traditional | 10/27/1978SE |
Questions and answers
When was Castle Tec-Test S.M.A.R.T. Pack cleared by the FDA?
Castle Tec-Test S.M.A.R.T. Pack (K833074) received a 510(k) decision of Substantially Equivalent on November 7, 1983, 59 days after the submission was received.
What is the product code of K833074?
The FDA product code is JOJ – Indicator, Physical/Chemical Sterilization Process, a Class II (moderate risk) device regulated under 21 CFR 880.2800.