Modified Browne Packaging and Label Steam Process Indicator
FDA 510(k) K032801 · Albert Browne , Ltd.
510(k) numberK032801
Submission
- Device name
- Modified Browne Packaging and Label Steam Process Indicator
- Applicant
- Albert Browne , Ltd.
North Attleboro, MA, US - Received
- September 9, 2003
- Decision date
- October 17, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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
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 |
|---|---|---|
| K063285 | Reliance Ci Process IndicatorJOJ · Traditional | 01/12/2007SE |
| K061738 | Albert Browne Ltd. Verify Steam and Eo Load Record CardJOJ · Traditional | 08/25/2006SE |
| K053479 | Verify Dry Heat LabelJOJ · Traditional | 07/18/2006SE |
| K060066 | Verify 3-10 Min Flash IntegratorJOJ · Traditional | 03/24/2006SE |
| K060103 | Albert Browne Ltd. Verify Steam Value IndicatorsJOJ · Special | 03/07/2006SE |
| K051101 | Verify Flash IntegratorJOJ · Traditional | 12/06/2005SE |
| K051056 | Verify Self-Contained Biological IndicatorFRC · Traditional | 10/20/2005SE |
| K002741 | Browne TST Single Use Bowie Dick/Integrator Test PackJOJ · Traditional | 07/03/2002SE |
| K002937 | TST Control Integrator for Steam SterilizersLRT · Traditional | 11/05/2001SE |
| K012335 | Browne Metrex 1.8% Glutaraldehyde Indicator for Metricide 28 and Metricide Plus 30…JOJ · Traditional | 10/01/2001SE |
Questions and answers
When was Modified Browne Packaging and Label Steam Process Indicator cleared by the FDA?
Modified Browne Packaging and Label Steam Process Indicator (K032801) received a 510(k) decision of Substantially Equivalent on October 17, 2003, 38 days after the submission was received.
What is the product code of K032801?
The FDA product code is JOJ – Indicator, Physical/Chemical Sterilization Process, a Class II (moderate risk) device regulated under 21 CFR 880.2800.