510(k) · Cleared
Recalled · Class II · 2016Acecide-C 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 Feb 5, 2010 as substantially equivalent to K041984 (Best Sanitizers, Inc., 2005) after a 287-day review. Its family tree reaches back 1 generation to 2005. It has been recalled once.
- Decided
- Feb 5, 2010
- Review
- 287 days
- Class
- Class II
- Product code
- MED
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K041984 (2005). No later device cites it as a predicate yet.
- Root · 1 generation backK041984 Acecide High-Level Disinfectant and SterilantBest Sanitizers, Inc. · 2005
- This deviceK091210 Acecide-C High Level Disinfectant and SterilantBest Sanitizers, Inc. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K041984 | Acecide High-Level Disinfectant and Sterilant | Best Sanitizers, Inc. | 2005 | — |
| 0 (this device) | K091210 | Acecide-C High Level Disinfectant and Sterilant | Best Sanitizers, Inc. | 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 |
|---|---|---|---|
| * | K041984 | Acecide High-Level Disinfectant and SterilantSummary page 1…High-Level Disinfectant and Sterilant Classification Name: Not Classified d. Predicate Name Acecide High Level Disinfectant and Sterilant (K04 1984) e. Summary of the substantial equivalence (SE) of ACECIDE-C High-Level Disinfectant and Sterilant to the pre… | 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 2, 2016 | Class II | Z-2714-2016 | Nonconforming Material/Component | Certain lots of the acid solution in Acecide-C are degrading faster than normal. |
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 K041984.
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?
ACECIDE-C is a high level disinfectant intended to disinfect reusable clean heat-sensitive semi-critical medical devices (such as flexible endloscopes) which contact mucous membranes when used at or above its minimum recommended concentration of 2000 ppm peracetic acid for 7.0 minutes at 200C. ACECIDE-C is a sterilant intended to sterilize reusable clean heat-sensitive critical and semi-critical medical devices (such as flexible endloscopes) which…
Read the full statement (131 words)
ACECIDE-C is a high level disinfectant intended to disinfect reusable clean heat-sensitive semi-critical medical devices (such as flexible endloscopes) which contact mucous membranes when used at or above its minimum recommended concentration of 2000 ppm peracetic acid for 7.0 minutes at 200C.
ACECIDE-C is a sterilant intended to sterilize reusable clean heat-sensitive critical and semi-critical medical devices (such as flexible endloscopes) which contact and potentially penetrate into sterile body areas, for which there is no other practical method of sterilization, when used at or above its minimum recbmmended concentration of 2000 ppm peracetic acid for 2.0 hours at 200 C.
ACECIDE Test Strips are used with ACECIE-C High Level Disinfectant and Sterilant use solution to ensure that the level of peracetic acid is above the minimum recommended concentration of 2000 ppm.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091210 · printed Nov 5, 2026
Cite this page
510(k) Report. “K091210: Acecide-C 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/K091210
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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