510(k) · Cleared

Recalled · 2005

Browne GA Indicator for Cidex Products

K981054510(k) TraditionalCleared Dec 7, 1998259-day reviewClass II21 CFR 880.2800Recalls 3

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 Dec 7, 1998 as substantially equivalent to K922481 (Board of Directors, Albert Browne, Ltd., 1994) and 1 other predicate after a 259-day review. Its family tree reaches back 1 generation to 1993. 1 later device descends from it. It has been recalled 3 times.

Decided: Dec 7, 1998
Review: 259 days
Class: Class II
Product code: JOJ
Recalls: 3
Predicates: 2

Its longest line of descent runs back 1 generation to K924681 (1993). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK924681 Glutaraldehyde MonitorsPymah Corp. · 1993
This deviceK981054 Browne GA Indicator for Cidex ProductsAlbert Browne, Ltd. · 1998
Descendant · cites it directly · 0 of its ownK083295 Serim Disintek Gta 2.1%, Model: 5164Serim Research Corp. · 2009

Most influential descendants

Showing 1 of 1 · See all

K083295Serim Disintek Gta 2.1%, Model: 5164Serim Research Corp. · 2009 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K924681	Glutaraldehyde Monitors	Pymah Corp.	1993	—
0 (this device)	K981054	Browne GA Indicator for Cidex Products	Albert Browne, Ltd.	1998	—
+1	K083295	Serim Disintek Gta 2.1%, Model: 5164	Serim Research Corp.	2009	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	1	0

FIG. 1 — Lineage of K981054, 1993–2009Source: 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

Get a 510(k) Report

What was it cleared against? (2)

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 …me: Glutaraldehyde Concentration Indicator Classification Name: Physical/Chemical Sterilization Process Indicator 3. PREDICATE DEVICES Browne GA Indicator, subject of K922481 Cold Sterilog Glutaraldehyde Monitor, subject of K924681 4, INTENDED USE The Browne GA Indicator for Cidex Plus™ 28 Day Solutio…	Board of Directors, Albert Browne, Ltd.	1994	3
*	K924681	Glutaraldehyde Monitors Summary page 1 …Name: Physical/Chemical Sterilization Process Indicator 3. PREDICATE DEVICES Browne GA Indicator, subject of K922481 Cold Sterilog Glutaraldehyde Monitor, subject of K924681 4, INTENDED USE The Browne GA Indicator for Cidex Plus™ 28 Day Solution (Browne Cidex Indicator) is a concentration monitor for…	Pymah Corp.	1993	—

Also cleared against K922481: 4 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K083295	Serim Disintek Gta 2.1%, Model: 5164	Serim Research Corp.	2009	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Mar 16, 2005	Not classified	Z-0779-05	Other	CIDEX test strips were found to pass solution below MEC.
Sep 4, 2003	Not classified	Z-1479-04	Other	Performance failure complaints.
Feb 14, 2003	Not classified	Z-0695-03	Other	Test strips which are used for QC of sterilant solution fail due to ingress of moisture.

No ancestor or descendant has a Class I recall.

What does this lineage say?

1 of the 2 ancestors has a recall of any class.
Of its descendants, K083295 (Serim Research Corp., 2009) has gone furthest, with 0 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 GA Indicator for Cidex Plus™ 28 Day Solution is a concentration monitor for use in glutaraldehyde-containing germicide solutions with a minimum effective concentration of 2.1%.

The Browne GA Indicator for Cidex Plus™ 28 Day Solution is dedicated for use with Cidex Plus™ 28 Day Solution.

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/K981054 · printed Nov 4, 2026

Cite this page

510(k) Report. “K981054: Browne GA Indicator for Cidex Products.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981054

Report an extraction error

Are you the manufacturer?

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