510(k) · Cleared
ClearedAcecide High-Level Disinfectant and Sterilant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Best Sanitizers, Inc. · MED Sterilant, Medical Devices
Cleared on May 11, 2005 after a 292-day review. The FDA summary names its predicate without a number. 9 later devices descend from it.
- Decided
- May 11, 2005
- Review
- 292 days
- Class
- Class II
- Product code
- MED
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 2 citing it directly.
- This deviceK041984 Acecide High-Level Disinfectant and SterilantBest Sanitizers, Inc. · 2005
- Descendant · cites it directly · 7 of its ownK082988 Medivators Advantage Plus Endoscope Reprocessing System, Rapicide PA…Medivators Reprocessing Systems · 2009 · Recalled
- Descendant · 2 generations on · 2 of its ownK152394 Rapicide PA High-Level Disinfectant Test StripsMedivators, Inc. · 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 ownK251035 DISINTEK™ PA Test StripsSerim Research · 2025
- Descendant · 3 generations on · 0 of its ownK251048 Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118STERIS Corporation · 2025
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K082988Medivators Advantage Plus Endoscope Reprocessing System, Rapicide PA High Level…Medivators Reprocessing Systems · 2009 · cites it directly7descendants
- K152394Rapicide PA High-Level Disinfectant Test StripsMedivators, Inc. · 2016 · 2 generations on2descendants
- K192228CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical TD-12…Cs Medical, LLC · 2020 · 2 generations on1descendant
- K251035DISINTEK™ PA Test StripsSerim Research · 2025 · 3 generations on0descendants
- K251048Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118STERIS Corporation · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K041984 | Acecide High-Level Disinfectant and Sterilant | Best Sanitizers, Inc. | 2005 | — |
| +1 | K082988 | Medivators Advantage Plus Endoscope Reprocessing System, Rapicide PA High… | Medivators Reprocessing Systems | 2009 | 4 |
| +2 | K152394 | Rapicide PA High-Level Disinfectant Test Strips | Medivators, Inc. | 2016 | — |
| +2 | K192228 | CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical… | Cs Medical, LLC | 2020 | — |
| +3 | K251035 | DISINTEK™ PA Test Strips | Serim Research | 2025 | — |
| +3 | K251048 | Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118 | STERIS Corporation | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 2 | 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? (2)
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 |
|---|---|---|---|
| * | — | Minntech Peract® 20 Liquid Sterilant/Disinfectant Named without a submission number | |
| * | — | Medivators Rapicide™ High Level Disinfectant and Sterilant Named without a submission number |
What descends from it? (9)
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, K082988 (Medivators Reprocessing Systems, 2009) has gone furthest, with 7 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?
Acecide High-Level Disinfectant and Sterilant is intended to be used for the automated sterilization or high-level disinfection of clean, heat sensitive, critical or semi-critical medical devices that are not compatible with other sterilization or high-level disinfection processes that can be biologically monitored. Acecide High-Level Disinfectant and Sterilant should be used under the following contact conditions: Sterilization: 5 hours, 25°C, 1900 ppm…
Read the full statement (96 words)
Acecide High-Level Disinfectant and Sterilant is intended to be used for the automated sterilization or high-level disinfection of clean, heat sensitive, critical or semi-critical medical devices that are not compatible with other sterilization or high-level disinfection processes that can be biologically monitored.
Acecide High-Level Disinfectant and Sterilant should be used under the following contact conditions:
Sterilization: 5 hours, 25°C, 1900 ppm peracetic acid
High-Level Disinfection: 5 minutes, 25°C, 1900 ppm peracetic acid
Acecide Peracetic Acid Test Strips are intended for verifying the minimum recommended concentration of peracetic acid in Acecide High-Level Disinfectant and Sterilant during reuse.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041984 · printed Nov 5, 2026
Cite this page
510(k) Report. “K041984: Acecide High-Level Disinfectant and Sterilant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041984
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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