510(k) · Cleared
ClearedAldahol Iii High-Level Disinfectant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Healthpoint, Ltd. · MED Sterilant, Medical Devices
Cleared on May 5, 2005 after a 349-day review. The FDA summary names its predicate without a number. 2 later devices descend from it.
- Decided
- May 5, 2005
- Review
- 349 days
- Class
- Class II
- Product code
- MED
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK041360 Aldahol Iii High-Level DisinfectantHealthpoint, Ltd. · 2005
- Descendant · cites it directly · 0 of its ownK113015 Aldahol V High Level DisinfectantMicrochem Laboratories, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK091890 Extended Use Aldahol High Level DisinfectantHealthpoint, Ltd. · 2010
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 |
|---|---|---|---|---|---|
| 0 (this device) | K041360 | Aldahol Iii High-Level Disinfectant | Healthpoint, Ltd. | 2005 | — |
| +1 | K113015 | Aldahol V High Level Disinfectant | Microchem Laboratories, Inc. | 2012 | — |
| +1 | K091890 | Extended Use Aldahol High Level Disinfectant | Healthpoint, Ltd. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 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 |
|---|---|---|---|
| * | — | Cidex Activated Dialdehyde Solution Named without a submission number |
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?
- Of its descendants, K113015 (Microchem Laboratories, Inc., 2012) has gone furthest, with 0 descendants of its own.
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?
Sterilization: Aldahol III High-Level Disinfectant is a sterilant intended for the
sterilization of reusable, clean, heat-sensitive medical devices when used as directed at
or above its minimum recommended concentrations (MRC) of 2.1% alkaline
glutaraldehyde and 15.0% isopropanol with an exposure of 10.0 hrs at 20 C.
High-Level Disinfection: Aldahol III High-Level Disinfectant is a high-level disinfectant
intended for the disinfection of reusable, clean, heat-sensitive medical devices when
used as directed at or above its MRC of 2.1% alkaline glutaraldehyde and 15.0%
isopropanol with an exposure of 10.0 min at 20 C.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041360 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041360: Aldahol Iii High-Level Disinfectant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041360
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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