510(k) · Cleared
ClearedOpa 30 Solution
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ciden Technologies, LLC · MED Sterilant, Medical Devices
Cleared on Aug 19, 2014 as substantially equivalent to K070627 (Ciden Technologies, LLC, 2007) after a 152-day review. Its family tree reaches back 3 generations to 1999.
- Decided
- Aug 19, 2014
- Review
- 152 days
- Class
- Class II
- Product code
- MED
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K991487 (1999). No later device cites it as a predicate yet.
- Root · 3 generations backK991487 Cidex Opa SolutionAdvanced Sterilization Products · 1999
- 2 generations backK030004 0.55% Orth-Phthalaldehyde SolutionAdvanced Sterilization Products · 2003 · Recalled
- 1 generation backK070627 Opaciden SolutionCiden Technologies, LLC · 2007
- This deviceK140703 Opa 30 SolutionCiden Technologies, LLC · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K991487 | Cidex Opa Solution | Advanced Sterilization Products | 1999 | — |
| −2 | K030004 | 0.55% Orth-Phthalaldehyde Solution | Advanced Sterilization Products | 2003 | 2 |
| −1 | K070627 | Opaciden Solution | Ciden Technologies, LLC | 2007 | — |
| 0 (this device) | K140703 | Opa 30 Solution | Ciden Technologies, LLC | 2014 | — |
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 MED? 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 MED device
- #1 K251666 SYSTEM 1E Liquid Chemical Sterilant Processing…score 13.8 · 10 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 |
|---|---|---|---|
| * | K070627 | Opaciden SolutionSummary page 4…II Product Code: MED FDA review panel code: INCB 3. Predicate Device: The legally marketed predicate device is Opaciden® Solution (K070627), Product Code MED, manufactured by Ciden Technologies LLC and determined to be substantially equivalent to a legally m… | 2007 |
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 15 years and passes through 2 companies; a new generation was cleared every 4.4 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 2 other devices also cite its predicate K070627.
How does its category compare?
All MED devicesMED Sterilant, Medical Devices: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · MED
2in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · MED
84in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MED
2in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MED
9in 2025
MAUDE reports naming product code MED, 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 | 2 | — | 3 | 34 |
| 2008 | 1 | — | 2 | 79 |
| 2009 | 0 | — | 0 | 158 |
| 2010 | 6 | 281 | 0 | 89 |
| 2011 | 0 | — | 2 | 106 |
| 2012 | 3 | 111 | 0 | 337 |
| 2013 | 1 | — | 0 | 140 |
| 2014 | 1 | — | 0 | 105 |
| 2015 | 0 | — | 0 | 110 |
| 2016 | 1 | — | 0 | 135 |
| 2017 | 1 | — | 0 | 74 |
| 2018 | 2 | — | 0 | 42 |
| 2019 | 4 | 84 | 0 | 35 |
| 2020 | 0 | — | 0 | 32 |
| 2021 | 2 | — | 0 | 31 |
| 2022 | 1 | — | 0 | 16 |
| 2023 | 2 | — | 0 | 9 |
| 2024 | 0 | — | 0 | 8 |
| 2025 | 0 | — | 0 | 9 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
OPA 30 Solution is a high level disinfectant for reprocessing heat sensitive semi-critical medical devices for which sterilization is not suitable, and when used according to the Directions for Use. OPA 30 Solution may be used or reused at or above its Minimum Recommended Concentration (MRC) of 0.3%, as determined by Opaciden OPA Reagent Strips, in manual reprocessing with an immersion time of at least 12 minutes at a minimum of 20°C (68°F), for a reuse…
Read the full statement (146 words)
OPA 30 Solution is a high level disinfectant for reprocessing heat sensitive semi-critical medical devices for which sterilization is not suitable, and when used according to the Directions for Use. OPA 30 Solution may be used or reused at or above its Minimum Recommended Concentration (MRC) of 0.3%, as determined by Opaciden OPA Reagent Strips, in manual reprocessing with an immersion time of at least 12 minutes at a minimum of 20°C (68°F), for a reuse period not to exceed 30 days. OPA 30 Solution may also be used or reused in a legally marketed automatic endoscope reprocessor (that can be set to a minimum of 25°C), at or above its Minimum Recommended Concentration (MRC), as determined by Opaciden OPA Reagent Strips, with an immersion time of at least 5 minutes at a minimum of 25°C (77°F), for a reuse period not to exceed 14 days.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140703 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140703: Opa 30 Solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140703
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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