510(k) · Cleared

Cleared

Cidex Opa Solution Test Strip

K992341510(k) TraditionalCleared Nov 23, 1999133-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

Serim Research Corp. · JOJ Indicator, Physical/Chemical Sterilization Process

Cleared on Nov 23, 1999 as substantially equivalent to K915170 (Pymah Corp., 1992) after a 133-day review. Its family tree reaches back 1 generation to 1992.

Decided: Nov 23, 1999
Review: 133 days
Class: Class II
Product code: JOJ
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K915170 (1992). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK915170 Pymah Cold Sterilog Glutaraldehyde MonitorPymah Corp. · 1992
This deviceK992341 Cidex Opa Solution Test StripSerim Research Corp. · 1999

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K915170	Pymah Cold Sterilog Glutaraldehyde Monitor	Pymah Corp.	1992	—
0 (this device)	K992341	Cidex Opa Solution Test Strip	Serim Research Corp.	1999	—

FIG. 1 — Lineage of K992341, 1992–1999Source: 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
*	K915170	Pymah Cold Sterilog Glutaraldehyde Monitor Summary page 1 …rips for ortho-Phthalaldehyde (OPA) in CIDEX® OPA Solution Classification Name: Chemical Sterilization Process Indicator PREDICATE DEVICE Cidex® Solution Test Strips (K915170) DESCRIPTION OF THE CIDEX® OPA SOLUTION TEST STRIP The CIDEX® OPA Solution Test Strips consist of a 0.2 x 0.2-inch reagent-cont…	Pymah Corp.	1992	—

Also cleared against K915170: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 no recall.
2 other devices also cite its predicate K915170.

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?

CIDEX* OPA Solution Test Strips are semi-quantitative chemical

indicators used to determine whether the concentration of active

ingredient in CIDEX* OPA Solution is above or below the minimum

effective concentration of 0.3% OPA. CIDEX* OPA Solution Test

Strips cannot be used to validate the sterilization or

disinfection process.

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/K992341 · printed Nov 4, 2026

Cite this page

510(k) Report. “K992341: Cidex Opa Solution Test Strip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992341

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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