510(k) · Cleared

Cleared

TST Control Integrator for Steam Sterilizers

K002937510(k) TraditionalCleared Nov 5, 2001410-day reviewClass II21 CFR 880.2800

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Albert Browne, Ltd. · LRT Indicator, Sterilization

Cleared on Nov 5, 2001 after a 410-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 later devices descend from it.

Decided: Nov 5, 2001
Review: 410 days
Class: Class II
Product code: LRT
Recalls: None
Predicates: 0

7 later devices descend from it, 5 citing it directly.

This deviceK002937 TST Control Integrator for Steam SterilizersAlbert Browne, Ltd. · 2001
Descendant · cites it directly · 2 of its ownK071895 Verify 275 Degree F. 3-10 Indicator; 10 Indicator; 3 IndicatorSTERIS Corporation · 2007
Descendant · cites it directly · 1 of its ownK083643 Verify 275F Gravity IndicatorsSTERIS Corporation · 2009
Descendant · cites it directly · 1 of its ownK051101 Verify Flash IntegratorAlbert Browne, Ltd. · 2005
Descendant · 2 generations on · 0 of its ownK162758 VERIFY SixCess Steam Indicators, VERIFY SixCess Flash Indicators…STERIS Corporation · 2017 · Recalled
Descendant · 2 generations on · 0 of its ownK102894 Classix Chemical Sterilization IndicatorPropper Mfg. Co., Inc. · 2011

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2005high 2 (2007) · low 0 (2008)2026

Most influential descendants

Showing 5 of 7 · See all

K071895Verify 275 Degree F. 3-10 Indicator; 10 Indicator; 3 IndicatorSTERIS Corporation · 2007 · cites it directly2descendants
K083643Verify 275F Gravity IndicatorsSTERIS Corporation · 2009 · cites it directly1descendant
K051101Verify Flash IntegratorAlbert Browne, Ltd. · 2005 · cites it directly1descendant
K162758VERIFY SixCess Steam Indicators, VERIFY SixCess Flash Indicators, VERIFY Bowie Dick Test…STERIS Corporation · 2017 · 2 generations on0descendants
K102894Classix Chemical Sterilization IndicatorPropper Mfg. Co., Inc. · 2011 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K002937	TST Control Integrator for Steam Sterilizers	Albert Browne, Ltd.	2001	—
+1	K071895	Verify 275 Degree F. 3-10 Indicator; 10 Indicator; 3 Indicator	STERIS Corporation	2007	—
+1	K083643	Verify 275F Gravity Indicators	STERIS Corporation	2009	—
+1	K051101	Verify Flash Integrator	Albert Browne, Ltd.	2005	—
+2	K162758	VERIFY SixCess Steam Indicators, VERIFY SixCess Flash Indicators, VERIFY Bowie…	STERIS Corporation	2017	1
+2	K102894	Classix Chemical Sterilization Indicator	Propper Mfg. Co., Inc.	2011	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2006	1	0
2007	2	0
2009	1	0
2011	1	0
2017	1	0

FIG. 1 — Lineage of K002937, 2001–2017Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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

Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (7)

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K071895	Verify 275 Degree F. 3-10 Indicator; 10 Indicator; 3 Indicator	STERIS Corporation	2007	2
K083643	Verify 275F Gravity Indicators	STERIS Corporation	2009	1
K051101	Verify Flash Integrator	Albert Browne, Ltd.	2005	1
K062651	Prochem Ext Chemical Integrator	Raven Biological Laboratories, Inc.	2007	0
K060066	Verify 3-10 Min Flash Integrator	Albert Browne, Ltd.	2006	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?

Of its descendants, K071895 (STERIS Corporation, 2007) has gone furthest, with 2 descendants of its own.

How does its category compare?

All LRT devices

LRT 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

2007high 4 (2023) · low 0 (2007)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	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	4
2024	—	0
2025	—	4
2026	—	—

https://510kreport.com/device/K002937 · printed Nov 5, 2026

Cite this page

510(k) Report. “K002937: TST Control Integrator for Steam Sterilizers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K002937

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026