510(k) · Cleared
ClearedSerim Disintek Opa Test Strip
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Serim Research Corp. · JOJ Indicator, Physical/Chemical Sterilization Process
Cleared on Jul 11, 2008 as substantially equivalent to K991709 (Albert Browne, Ltd., 1999) after a 57-day review. Its family tree reaches back 2 generations to 1994. 2 later devices descend from it.
- Decided
- Jul 11, 2008
- Review
- 57 days
- Class
- Class II
- Product code
- JOJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K922481 (1994). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK922481 Browne GA Indicator Use in 2% Activ GlutaraldehydeBoard of Directors, Albert Browne, Ltd. · 1994 · Recalled
- 1 generation backK991709 Browne Cidex Opa IndicatorAlbert Browne, Ltd. · 1999 · Recalled
- This deviceK081370 Serim Disintek Opa Test StripSerim Research Corp. · 2008
- Descendant · cites it directly · 0 of its ownK202565 WAVICIDE-OPA MEC IndicatorSerim Research Corporation · 2020
- Descendant · cites it directly · 0 of its ownK120652 Rapicide Opa-28 Test StripSerim Research Corp. · 2012
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K922481 | Browne GA Indicator Use in 2% Activ Glutaraldehyde | Board of Directors, Albert Browne, Ltd. | 1994 | 3 |
| −1 | K991709 | Browne Cidex Opa Indicator | Albert Browne, Ltd. | 1999 | 1 |
| 0 (this device) | K081370 | Serim Disintek Opa Test Strip | Serim Research Corp. | 2008 | — |
| +1 | K202565 | WAVICIDE-OPA MEC Indicator | Serim Research Corporation | 2020 | — |
| +1 | K120652 | Rapicide Opa-28 Test Strip | Serim Research Corp. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2020 | 1 | 0 |
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 |
|---|---|---|---|
| * | K991709 | Browne Cidex Opa IndicatorSummary page 1…Substantial Equivalence: The Serim DISINTEK OPA Test Strip is substantially equivalent to Cidex® OPA Solution Test Strip; K99 1709. Device Description: The device is a qualitative, single use, reagent test strip… | 1999 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 14 years and passes through 3 companies; a new generation was cleared every 8.8 years on median.
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K202565 (Serim Research Corporation, 2020) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K991709.
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. 2008, 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 Serim® DISINTEKTM OPA Test Strip is a chemical indicator for use in determining whether the concentration of ortho-phthalaldehyde, the active ingredient in Cidex® OPA Solution, is above or below the minimum effective concentration (MEC) established for Cidex OPA Solution.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081370 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081370: Serim Disintek Opa Test Strip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081370
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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