TST Control Integrator for Steam Sterilizers
FDA 510(k) K002937 · Albert Browne , Ltd.
510(k) numberK002937
Submission
- Device name
- TST Control Integrator for Steam Sterilizers
- Applicant
- Albert Browne , Ltd.
North Attleboro, MA, US - Received
- September 21, 2000
- Decision date
- November 5, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LRT – Indicator, Sterilization
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.2800
- Specialty
- General Hospital
Other 510(k)s with product code LRT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K965154 | TST Control Integrator for Steam AutoclaveLRT · Traditional | Albert Browne , Ltd. | 09/19/1997SE |
| K951113 | Cross-ChecksLRT · Traditional | Steritec Products Mfg Co, Inc. | 08/19/1996SE |
| K951703 | Tamper Evident Arrows with and Without Sterilization IndicatorsLRT · Traditional | Products For Medicine | 06/28/1995SE |
| K871672 | Sterilization Indicator for Flash SterilizationLRT · Traditional | Propper Mfg. Co., Inc. | 06/01/1987SE |
More from Propper Mfg. Co., Inc.
| 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 |
| K032801 | Modified Browne Packaging and Label Steam Process IndicatorJOJ · Special | 10/17/2003SE |
| K002741 | Browne TST Single Use Bowie Dick/Integrator Test PackJOJ · Traditional | 07/03/2002SE |
| K012335 | Browne Metrex 1.8% Glutaraldehyde Indicator for Metricide 28 and Metricide Plus 30…JOJ · Traditional | 10/01/2001SE |
Questions and answers
When was TST Control Integrator for Steam Sterilizers cleared by the FDA?
TST Control Integrator for Steam Sterilizers (K002937) received a 510(k) decision of Substantially Equivalent on November 5, 2001, 410 days after the submission was received.
What is the product code of K002937?
The FDA product code is LRT – Indicator, Sterilization, a Class II (moderate risk) device regulated under 21 CFR 880.2800.