510(k) · Cleared
ClearedAldahol V High Level Disinfectant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Microchem Laboratories, Inc. · MED Sterilant, Medical Devices
Cleared on Jan 30, 2012 as substantially equivalent to K041360 (Healthpoint, Ltd., 2005) after a 111-day review. Its family tree reaches back 1 generation to 2005.
- Decided
- Jan 30, 2012
- Review
- 111 days
- Class
- Class II
- Product code
- MED
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K041360 (2005). No later device cites it as a predicate yet.
- Root · 1 generation backK041360 Aldahol Iii High-Level DisinfectantHealthpoint, Ltd. · 2005
- This deviceK113015 Aldahol V High Level DisinfectantMicrochem Laboratories, Inc. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K041360 | Aldahol Iii High-Level Disinfectant | Healthpoint, Ltd. | 2005 | — |
| 0 (this device) | K113015 | Aldahol V High Level Disinfectant | Microchem Laboratories, Inc. | 2012 | — |
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 |
|---|---|---|---|
| * | K041360 | Aldahol Iii High-Level DisinfectantSummary page 2…C-1 e. Summary of the substantial eqiuivalence (SE) of Aldahol V High Level Disinfectant to the predicate. Aldahol III High Level Disinifectant (K041360) Aldahol V High Level Disinfectant (HILD) is exactly the same formulation as the predicate, Aldahol III High Level Disinfectant… | 2005 |
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K041360.
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?
Aldahol® V High Level Disinfectant is intended for the high level disinfection of reusable, clean, heat-sensitive, semi-critical medical devices which contact intact mucous membranes when the disinfectant is used at or above its minimum recommended concentration of 1.8% glutaraldehyde for 10.0 min at 20°C. Aldahol V High Level Disinfectant is intended for the sterilization of reusable, clean, heat-sensitive critical and semi-critical medical devices…
Read the full statement (130 words)
Aldahol® V High Level Disinfectant is intended for the high level disinfection of reusable, clean, heat-sensitive, semi-critical medical devices which contact intact mucous membranes when the disinfectant is used at or above its minimum recommended concentration of 1.8% glutaraldehyde for 10.0 min at 20°C.
Aldahol V High Level Disinfectant is intended for the sterilization of reusable, clean, heat-sensitive critical and semi-critical medical devices which contact and potentially penetrate into sterile body areas, for which there is no other practical method of sterilization available with a biological indicator, when the disinfectant is used at or above its minimum recommended concentration of 1.8% glutaraldehyde for 8.0 hrs at 20°C.
Aldahol V High Level Disinfectant may be used in a legally marketed, validated, automatic endoscope reprocessor machine or in a manual bucket system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113015 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113015: Aldahol V 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/K113015
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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