510(k) · Cleared

Cleared

Browne Metrex 1.8% Glutaraldehyde Indicator for Metricide 28 and Metricide Plus 30 Solutions

K012335510(k) TraditionalCleared Oct 1, 200169-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. · JOJ Indicator, Physical/Chemical Sterilization Process

Cleared on Oct 1, 2001 as substantially equivalent to K922481 (Board of Directors, Albert Browne, Ltd., 1994) after a 69-day review. Its family tree reaches back 1 generation to 1994. 10 later devices descend from it.

Decided: Oct 1, 2001
Review: 69 days
Class: Class II
Product code: JOJ
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K922481 (1994). 10 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK922481 Browne GA Indicator Use in 2% Activ GlutaraldehydeBoard of Directors, Albert Browne, Ltd. · 1994 · Recalled
This deviceK012335 Browne Metrex 1.8% Glutaraldehyde Indicator for Metricide 28 and…Albert Browne, Ltd. · 2001
Descendant · cites it directly · 8 of its ownK081600 Steris Resert XL Test StripSTERIS Corporation · 2008
Descendant · 2 generations on · 5 of its ownK102217 System 1E Chemical IndicatorSTERIS Corporation · 2010
Descendant · 3 generations on · 3 of its ownK173428 VERIFY Chemical Indicator for S40 SterilantSTERIS Corporation · 2018
Descendant · 4 generations on · 1 of its ownK240032 Celerity Chemical Indicator for enspire 3000 CLCSPSSTERIS Corporation · 2024
Descendant · 2 generations on · 1 of its ownK102296 Verify Chemical Monitoring Strip for Resert Soultions (Resert XL…STERIS Corporation · 2011

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2008high 2 (2023) · low 0 (2009)2026

Most influential descendants

Showing 5 of 10 · See all

K081600Steris Resert XL Test StripSTERIS Corporation · 2008 · cites it directly8descendants
K102217System 1E Chemical IndicatorSTERIS Corporation · 2010 · 2 generations on5descendants
K173428VERIFY Chemical Indicator for S40 SterilantSTERIS Corporation · 2018 · 3 generations on3descendants
K240032Celerity Chemical Indicator for enspire 3000 CLCSPSSTERIS Corporation · 2024 · 4 generations on1descendant
K102296Verify Chemical Monitoring Strip for Resert Soultions (Resert XL Test Strip Version 2)STERIS Corporation · 2011 · 2 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K922481	Browne GA Indicator Use in 2% Activ Glutaraldehyde	Board of Directors, Albert Browne, Ltd.	1994	3
0 (this device)	K012335	Browne Metrex 1.8% Glutaraldehyde Indicator for Metricide 28 and Metricide…	Albert Browne, Ltd.	2001	—
+1	K081600	Steris Resert XL Test Strip	STERIS Corporation	2008	—
+2	K102217	System 1E Chemical Indicator	STERIS Corporation	2010	—
+3	K173428	VERIFY Chemical Indicator for S40 Sterilant	STERIS Corporation	2018	—
+4	K240032	Celerity Chemical Indicator for enspire 3000 CLCSPS	STERIS Corporation	2024	—
+2	K102296	Verify Chemical Monitoring Strip for Resert Soultions (Resert XL Test Strip…	STERIS Corporation	2011	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0
2010	1	0
2011	1	0
2015	1	0
2017	1	0
2018	1	0
2023	2	0
2024	2	0

FIG. 1 — Lineage of K012335, 1994–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 JOJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new JOJ device

#1 K261992 3M™ Attest™ Steam Chemical Integrator (1243A…score 13.3 · 5 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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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	Applicant	Decided	Recalls
*	K922481	Browne GA Indicator Use in 2% Activ Glutaraldehyde Summary page 1 …ual Name: Browne Metrex 1.8% Glutaraldehyde Indicator Classification Name: Physical/Chemical Sterilization Process Indicator 3. PREDICATE DEVICE Browne GA Indicator (K922481, Albert Browne Ltd.) 4. INTENDED USE The Browne Metrex 1.8% Glutaraldehyde Indicator for Metricide 28 and Metricide Plus 30 Sol…	Board of Directors, Albert Browne, Ltd.	1994	3

Also cleared against K922481: 4 other devices →

What descends from it? (10)

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

Number	Device	Applicant	Decided	Descendants
K081600	Steris Resert XL Test Strip	STERIS Corporation	2008	8
K172472	Micro-MEC 1.8% Glutaraldehyde Monitor Strip	STERIS Corporation	2017	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?

Its one ancestor has a recall.
Of its descendants, K081600 (STERIS Corporation, 2008) has gone furthest, with 8 descendants of its own.
4 other devices also cite its predicate K922481.

How does its category compare?

All JOJ devices

JOJ Indicator, Physical/Chemical Sterilization Process: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JOJ

6in 2025

2007high 13 (2011) · low 4 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JOJ

90in 2025

2007high 224 (2012) · low 38 (2019)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JOJ

1in 2023

2007high 2 (2008) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JOJ

12in 2025

2007high 39 (2023) · low 1 (2007)2025

MAUDE reports naming product code JOJ, 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	8	140	0	1
2008	9	57	2	1
2009	7	188	2	9
2010	6	115	0	3
2011	13	151	2	1
2012	7	224	0	8
2013	6	212	0	6
2014	6	198	0	11
2015	8	188	0	7
2016	4	150	0	11
2017	7	172	0	35
2018	5	150	0	12
2019	12	38	0	8
2020	7	108	0	6
2021	4	87	1	29
2022	8	90	0	23
2023	4	53	1	39
2024	12	71	0	25
2025	6	90	0	12
2026	3	30	0	—

What is it indicated for?

The Browne Metrex 1.8% Glutaraldehyde Indicator for Metricide® 28 and Metricide Plus 30 Solutions (Browne Metrex 1.8% Glutaraldehyde Indicator) is a glutaraldehyde concentration monitor for use in glutaraldehyde-containing germicide solutions with a minimum effective concentration of 1.8% glutaraldehyde.

The Browne Metrex 1.8% Glutaraldehyde Indicator is dedicated for use with Metricide® 28 and Metricide Plus 30® Solutions.

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/K012335 · printed Nov 4, 2026

Cite this page

510(k) Report. “K012335: Browne Metrex 1.8% Glutaraldehyde Indicator for Metricide 28 and Metricide Plus 30 Solutions.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012335

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026