510(k) · Cleared
ClearedWAVICIDE-OPA MEC Indicator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Serim Research Corporation · JOJ Indicator, Physical/Chemical Sterilization Process
Cleared on Dec 2, 2020 as substantially equivalent to K081370 (Serim Research Corp., 2008) after an 89-day review. Its family tree reaches back 3 generations to 1994.
- Decided
- Dec 2, 2020
- Review
- 89 days
- Class
- Class II
- Product code
- JOJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K922481 (1994). No later device cites it as a predicate yet.
- Root · 3 generations backK922481 Browne GA Indicator Use in 2% Activ GlutaraldehydeBoard of Directors, Albert Browne, Ltd. · 1994 · Recalled
- 2 generations backK991709 Browne Cidex Opa IndicatorAlbert Browne, Ltd. · 1999 · Recalled
- 1 generation backK081370 Serim Disintek Opa Test StripSerim Research Corp. · 2008
- This deviceK202565 WAVICIDE-OPA MEC IndicatorSerim Research Corporation · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K922481 | Browne GA Indicator Use in 2% Activ Glutaraldehyde | Board of Directors, Albert Browne, Ltd. | 1994 | 3 |
| −2 | K991709 | Browne Cidex Opa Indicator | Albert Browne, Ltd. | 1999 | 1 |
| −1 | K081370 | Serim Disintek Opa Test Strip | Serim Research Corp. | 2008 | — |
| 0 (this device) | K202565 | WAVICIDE-OPA MEC Indicator | Serim Research Corporation | 2020 | — |
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
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 |
|---|---|---|---|
| * | K081370 | Serim Disintek Opa Test StripSummary page 4…egulation Number: 21CFR 880.2800 Predicate Device: Serim® DISINTEK™ OPA Test Strips, Serim Research Corporation, P/N 5121; K081370. Device Description: The device is a qualitative, single use, reagent chemical indic… | 2008 |
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?
- The line of descent spans 26 years and passes through 4 companies; a new generation was cleared every 8.8 years on median.
- 2 of the 3 ancestors have a recall of any class.
- 1 other device also cites its predicate K081370.
How does its category compare?
All JOJ devicesJOJ Indicator, Physical/Chemical Sterilization Process: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · JOJ
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JOJ
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JOJ
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JOJ
12in 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 WAVICIDE-OPA® MEC Indicator is a chemical indicator for use in determining whether the concentration of ortho-phthalaldehyde, the active ingredient in the high-level disinfectant WAVICIDE-OPA® Solution, is above or below the minimum effective concentration (MEC) established for WAVICIDE-OPA 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/K202565 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202565: WAVICIDE-OPA MEC Indicator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202565
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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