Bowie-Dick Mini Pak, Model BD 115
FDA 510(k) K024293 · Steritec Products, Inc.
510(k) numberK024293
Submission
- Device name
- Bowie-Dick Mini Pak, Model BD 115
- Applicant
- Steritec Products, Inc.
Castle Rock, CO, US - Received
- December 24, 2002
- Decision date
- August 11, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 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 |
|---|---|---|
| K252306 | Verrix EVA STEAM Biological Indicator (BI) (Model: 1200), Verrix EVA STEAM Process…QVB · Traditional | 04/22/2026SE |
| K083650 | Emu-Graph 4 Emulator, Model Ci 144JOJ · Special | 03/05/2009SE |
| K080136 | Instant Readout Chemical Integrator Challenge Pack, Model Lt- 105JOJ · Traditional | 08/15/2008SE |
| K052516 | Steritec Container Cord - Ci 135, Steritec Process Indicator Labels - Ci 140, Steritec…JOJ · Abbreviated | 10/03/2005SE |
| K040901 | Steritec Emu-Graph, Model No. Ci 131/USJOJ · Traditional | 09/09/2004SE |
| K012732 | Integraph Flash, Model Ci 110JOJ · Traditional | 03/04/2002SE |
| K010534 | Cross-Checks Dual, Model Ci 125JOJ · Traditional | 08/06/2001SE |
| K003533 | Cross-Checks LF, Model Ci 119/S &Ci 119/LJOJ · Abbreviated | 02/07/2001SE |
| K003002 | Sterilization Process Indicator Tapes Model CI112 & CI123JOJ · Traditional | 12/08/2000SE |
| K002861 | Eo Gas Sterilization Process Indicator Tapes, Model Ci 124JOJ · Abbreviated | 11/29/2000SE |
Questions and answers
When was Bowie-Dick Mini Pak, Model BD 115 cleared by the FDA?
Bowie-Dick Mini Pak, Model BD 115 (K024293) received a 510(k) decision of Substantially Equivalent on August 11, 2003, 230 days after the submission was received.
What is the product code of K024293?
The FDA product code is JOJ – Indicator, Physical/Chemical Sterilization Process, a Class II (moderate risk) device regulated under 21 CFR 880.2800.