510(k) · Cleared
ClearedRapicide Opa-28
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Minntech Corp. · MED Sterilant, Medical Devices
Cleared on Sep 27, 2012 as substantially equivalent to K070627 (Ciden Technologies, LLC, 2007) and 2 other predicates after a 239-day review. Its family tree reaches back 3 generations to 1999. 3 later devices descend from it.
- Decided
- Sep 27, 2012
- Review
- 239 days
- Class
- Class II
- Product code
- MED
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K991487 (1999). 4 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- 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 deviceK120306 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
Most influential descendants
Showing 3 of 3 · See all- 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 |
|---|---|---|---|---|---|
| −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) | 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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (3)
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 2…Other Devices in Commercial Distribution Within the United States Rapicide OPA-28 is equivalent in performance and indications to predicate devices Metricide OPA Plus (K070627), Cidex OPA (K030004) and Rapicide (K993042). All of the products are liquid chemical high level disinfectant solutions with equi… | 2007 |
| * | K030004 | 0.55% Orth-Phthalaldehyde SolutionSummary page 2…mercial Distribution Within the United States Rapicide OPA-28 is equivalent in performance and indications to predicate devices Metricide OPA Plus (K070627), Cidex OPA (K030004) and Rapicide (K993042). All of the products are liquid chemical high level disinfectant solutions with equivalent intended use a… | 2003 |
| * | K993042 | Medivators 5 Minute High-Level DisinfectantSummary page 2…thin the United States Rapicide OPA-28 is equivalent in performance and indications to predicate devices Metricide OPA Plus (K070627), Cidex OPA (K030004) and Rapicide (K993042). All of the products are liquid chemical high level disinfectant solutions with equivalent intended use and indications for use.… | 2000 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K160921 | CS-Medical TD 100 Disinfector with TD-5 and TD-8 High Level Disinfectants, CS Medical… | 2016 | 2 |
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 13 years and passes through 3 companies; a new generation was cleared every 4.4 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K160921 (Cs Medical, LLC, 2016) has gone furthest, with 2 descendants of its own.
- 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. 2012, 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?
Rapicide OPA-28 is a high level disinfectant solution for reprocessing of heat sensitive semi-critical medical devices for which sterilization is not suitable. Rapicide OPA-28 may be used at or above its minimum recommended concentration (MRC) of 0.35% OPA as determined by Rapicide OPA-28 test strips in manual device reprocessing with an immersion time of at least 10 minutes at a minimum temperature of 20°C for a reuse period not to exceed 28 days.…
Read the full statement (122 words)
Rapicide OPA-28 is a high level disinfectant solution for reprocessing of heat sensitive semi-critical medical devices for which sterilization is not suitable. Rapicide OPA-28 may be used at or above its minimum recommended concentration (MRC) of 0.35% OPA as determined by Rapicide OPA-28 test strips in manual device reprocessing with an immersion time of at least 10 minutes at a minimum temperature of 20°C for a reuse period not to exceed 28 days. Rapicide OPA-28 may also be used in compatible legally marketed automatic endoscope reprocessors at or above its MRC as determined by Rapicide OPA-28 test strips with an immersion time of at least 5 minutes at a minimum temperature of 25°C for a reuse period not to exceed 28 days.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120306 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120306: Rapicide Opa-28.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120306
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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