510(k) · Cleared
ClearedTST Control Integrator for Steam Autoclave
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Albert Browne, Ltd. · LRT Indicator, Sterilization
Cleared on Sep 19, 1997 as substantially equivalent to K902958 (Board of Directors, Albert Browne, Ltd., 1990) after a 270-day review. Its family tree reaches back 1 generation to 1990. 1 later device descends from it.
- Decided
- Sep 19, 1997
- Review
- 270 days
- Class
- Class II
- Product code
- LRT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K902958 (1990). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK902958 TST Control Integrator for Steam AutoclaveBoard of Directors, Albert Browne, Ltd. · 1990
- This deviceK965154 TST Control Integrator for Steam AutoclaveAlbert Browne, Ltd. · 1997
- Descendant · cites it directly · 0 of its ownK062651 Prochem Ext Chemical IntegratorRaven Biological Laboratories, Inc. · 2007
Most influential descendants
Showing 1 of 1 · See all- K062651Prochem Ext Chemical IntegratorRaven Biological Laboratories, Inc. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K902958 | TST Control Integrator for Steam Autoclave | Board of Directors, Albert Browne, Ltd. | 1990 | — |
| 0 (this device) | K965154 | TST Control Integrator for Steam Autoclave | Albert Browne, Ltd. | 1997 | — |
| +1 | K062651 | Prochem Ext Chemical Integrator | Raven Biological Laboratories, Inc. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LRT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K902958 | TST Control Integrator for Steam AutoclaveSummary page 2…sterilization (270°F for 3 minutes) have been achieved. 5. DEVICE DESCRIPTION Albert Browne Ltd. received clearance for a TST Control Integrator for Steam Autoclave, K902958, which monitored sterilization cycles with a holding temperature/time combinations of 250°F (121°C)/15 min. The purpose of this s… | 1990 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K062651 | Prochem Ext Chemical Integrator | 2007 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All LRT devicesLRT Indicator, Sterilization: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LRT
FDA has decided no LRT device since 2007.
Median 510(k) review, days · LRT
Too few LRT 510(k)s in any year since 2007 to give a median.
Recalls per year · LRT
No recall names LRT since 2007.
Adverse event reports per year · LRT
4in 2025
MAUDE reports naming product code LRT, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 4 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The TST Control Integrator for Steam Autoclave is a steam sterilization process indicator
designed to indicate, through a yellow to blue color change, when a combination of
parameters (270°F, 3 min.) necessary for sterilization have been achieved.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K965154 · printed Nov 4, 2026
Cite this page
510(k) Report. “K965154: TST Control Integrator for Steam Autoclave.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K965154
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026