510(k) · Cleared
ClearedExtended Use Aldahol 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 Mar 24, 2010 as substantially equivalent to K041360 (Healthpoint, Ltd., 2005) after a 274-day review. Its family tree reaches back 1 generation to 2005.
- Decided
- Mar 24, 2010
- Review
- 274 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 deviceK091890 Extended Use Aldahol High Level DisinfectantHealthpoint, Ltd. · 2010
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) | K091890 | Extended Use Aldahol High Level Disinfectant | Healthpoint, Ltd. | 2010 | — |
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 1…Name: Liquid chemical sterilants/high level disinfectants (21 CFR 880.6885) Classification: Class II Predicate Name Aldahol Ill High-Level Disinfectant (K04 1360) Date Prepared March 19, 2010… | 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. 2010, 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?
Extended Use Aldahol 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 5.0 min at 250 C in an automated endoscope reprocessor with FDA-cleared capability to maintain the exposure of 5.0 min at 250 C. Extended Use Aldahol High…
Read the full statement (124 words)
Extended Use Aldahol 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 5.0 min at 250 C in an automated endoscope reprocessor with FDA-cleared capability to maintain the exposure of 5.0 min at 250 C.
Extended Use Aldahol 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, when the disinfectant is used at or above its minimum recommended concentration of 1.8% glutaraldlehyde for 6.0 hrs at 250 C.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091890 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091890: Extended Use Aldahol High Level Disinfectant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091890
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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