510(k) · Cleared
Recalled · Class II · 20150.55% Orth-Phthalaldehyde Solution
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Sterilization Products · MED Sterilant, Medical Devices
Cleared on Feb 27, 2003 as substantially equivalent to K991487 (Advanced Sterilization Products, 1999) after a 56-day review. Its family tree reaches back 1 generation to 1999. 6 later devices descend from it. It has been recalled 2 times.
- Decided
- Feb 27, 2003
- Review
- 56 days
- Class
- Class II
- Product code
- MED
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K991487 (1999). 6 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK991487 Cidex Opa SolutionAdvanced Sterilization Products · 1999
- This deviceK030004 0.55% Orth-Phthalaldehyde SolutionAdvanced Sterilization Products · 2003
- Descendant · cites it directly · 5 of its ownK070627 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
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K070627Opaciden SolutionCiden Technologies, LLC · 2007 · cites it directly5descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K991487 | Cidex Opa Solution | Advanced Sterilization Products | 1999 | — |
| 0 (this device) | K030004 | 0.55% Orth-Phthalaldehyde Solution | Advanced Sterilization Products | 2003 | — |
| +1 | 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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K991487 | Cidex Opa SolutionSummary page 1…Solution d. LEGALLY MARKETED DEVICE CIDEX@OPA Solution claims equivalence to the following legally marketed medical device: CIDEX@OPA Solution (K991487). e. DEVICEDESCRIPTION CIDEX@OPA Solution is formulated to contain 0.55% w/v of ortho-phthalaldehyde. The resultan… | 1999 |
What descends from it? (6)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 10, 2015 | Class II | Z-2774-2015 | Under Investigation by firm | Advanced Sterilization Products (ASP) is reminding all CIDEX OPA Solution customers to follow the warnings and rinsing procedure in their current labelling around the criticality of proper rinsing of medical device following disinfection… |
| Jun 1, 2012 | Class II | Z-2276-2012 | Process control | The recall was initiated because Advanced Sterilization Products has discovered instances of missing labels on bottles of CIDEX OPA Solution, Part # 20390 manufactured between May 2011 and April 2012. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All MED devicesMED Sterilant, Medical Devices: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
CIDEX@OPA Solution is a high level disinfectant for reprocessing heat sensitive medical devices, for which sterilization is not suitable, and when used according to the Directions for Use. Manual Processing: High Level Disinfectant at a minimum of 20°C (68°F): CIDEX@ OPA Solution is a high level disinfectant when used or reused, according to the Directions for Use, at or above its Minimum Effective Concentration (MEC) as determined by CIDEX@OPA Solution…
Read the full statement (202 words)
CIDEX@OPA Solution is a high level disinfectant for reprocessing heat sensitive medical devices, for which sterilization is not suitable, and when used according to the Directions for Use.
Manual Processing: High Level Disinfectant at a minimum of 20°C (68°F): CIDEX@ OPA Solution is a high level disinfectant when used or reused, according to the Directions for Use, at or above its Minimum Effective Concentration (MEC) as determined by CIDEX@OPA Solution Test Strips, with an immersion time of at least 12 minutes for a reuse period not to exceed 14 days.
Automatic Endoscope Reprocessors that can be set to 25°C: High Level Disinfectant at a minimum of 25°C (77°F): CIDEX@OPA Solution is a high level disinfectant when used or reused in a legally marketed automatic endoscope reprocessor (that can be set to 25°C) according to the Directions for Use, at or above its Minimum Effective Concentration (MEC) as determined by CIDEX@ OPA Solution Test Strips, with an immersion time of at least 5 minutes for a reuse period not to exceed 14 days.
Minimum Effective Concentration (MEC): 0.3%.
Note: If your AER cannot be set to a minimum of 25°C please follow the time and temperature stated in Indications for Use, Manual Processing.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030004 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030004: 0.55% Orth-Phthalaldehyde Solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030004
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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