510(k) · Cleared
ClearedOpaciden 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 2, 2007 as substantially equivalent to K030004 (Advanced Sterilization Products, 2003) after a 149-day review. Its family tree reaches back 2 generations to 1999. 5 later devices descend from it.
- Decided
- Aug 2, 2007
- Review
- 149 days
- Class
- Class II
- Product code
- MED
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K991487 (1999). 5 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK991487 Cidex Opa SolutionAdvanced Sterilization Products · 1999
- 1 generation backK030004 0.55% Orth-Phthalaldehyde SolutionAdvanced Sterilization Products · 2003 · Recalled
- This deviceK070627 Opaciden SolutionCiden Technologies, LLC · 2007
- Descendant · cites it directly · 3 of its ownK120306 Rapicide Opa-28Minntech Corp. · 2012
- Descendant · cites it directly · 2 of its ownK160921 CS-Medical TD 100 Disinfector with TD-5 and TD-8 High Level…Cs Medical, LLC · 2016
- Descendant · 2 generations on · 1 of its ownK192228 CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS…Cs Medical, LLC · 2020
- Descendant · 3 generations on · 0 of its ownK233049 TD 200® Automated TEE Probe Disinfector with TD-12® High-Level…Cs Medical, LLC · 2023
- Descendant · cites it directly · 0 of its ownK140703 Opa 30 SolutionCiden Technologies, LLC · 2014
Most influential descendants
Showing 5 of 5 · See all- K120306Rapicide Opa-28Minntech Corp. · 2012 · cites it directly3descendants
- K160921CS-Medical TD 100 Disinfector with TD-5 and TD-8 High Level Disinfectants, CS Medical…Cs Medical, LLC · 2016 · cites it directly2descendants
- K192228CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical TD-12…Cs Medical, LLC · 2020 · 2 generations on1descendant
- K233049TD 200® Automated TEE Probe Disinfector with TD-12® High-Level Disinfectant with…Cs Medical, LLC · 2023 · 3 generations on0descendants
- K140703Opa 30 SolutionCiden Technologies, LLC · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K991487 | Cidex Opa Solution | Advanced Sterilization Products | 1999 | — |
| −1 | K030004 | 0.55% Orth-Phthalaldehyde Solution | Advanced Sterilization Products | 2003 | 2 |
| 0 (this device) | K070627 | Opaciden Solution | Ciden Technologies, LLC | 2007 | — |
| +1 | K120306 | Rapicide Opa-28 | Minntech Corp. | 2012 | — |
| +1 | K160921 | CS-Medical TD 100 Disinfector with TD-5 and TD-8 High Level Disinfectants, CS… | Cs Medical, LLC | 2016 | — |
| +2 | K192228 | CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical… | Cs Medical, LLC | 2020 | — |
| +3 | K233049 | TD 200® Automated TEE Probe Disinfector with TD-12® High-Level Disinfectant… | Cs Medical, LLC | 2023 | — |
| +1 | K140703 | Opa 30 Solution | Ciden Technologies, LLC | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 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 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 |
|---|---|---|---|
| * | K030004 | 0.55% Orth-Phthalaldehyde SolutionSummary page 1…21 CFR § 880.6885, Product Code MED) Legally Marketed Device to which Equivalence is Claimed: The legally marketed predicate device is CIDEX® OPA Solution (K030004), manufactured by Advanced Sterilization Products, determined to be substantially equivalent to a legally marketed (preAmendment)… | 2003 |
What descends from it? (5)
3 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 8 years and passes through 2 companies; a new generation was cleared every 4.4 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K120306 (Minntech Corp., 2012) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K030004.
How does its category compare?
All MED devicesMED Sterilant, Medical Devices: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
Opaciden 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. Opaciden 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 200 C (680 F), for a reuse…
Read the full statement (146 words)
Opaciden 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. Opaciden 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 200 C (680 F), for a reuse period not to exceed 14 days. Opaciden may also be used or reused in a legally marketed automatic endoscope reprocessor (that can be set to a minimum of 250 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 250 C (770 F), for a reuse period not to exceed 14 days.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070627 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070627: Opaciden Solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070627
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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