510(k) · Cleared
Recalled · Class III · 2020Acu-sInQ Complete Endoscope Cleaning Aid System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
STERIS Corporation · FEB Accessories, Cleaning, For Endoscope
Cleared on Dec 14, 2018 as substantially equivalent to K914524 (United States Endoscopy Group, Inc., 1994) after a 155-day review. Its family tree reaches back 1 generation to 1994. It has been recalled once.
- Decided
- Dec 14, 2018
- Review
- 155 days
- Class
- Class II
- Product code
- FEB
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K914524 (1994). No later device cites it as a predicate yet.
- Root · 1 generation backK914524 Fluid Pump, CP #3United States Endoscopy Group, Inc. · 1994
- This deviceK181865 Acu-sInQ Complete Endoscope Cleaning Aid SystemSTERIS Corporation · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K914524 | Fluid Pump, CP #3 | United States Endoscopy Group, Inc. | 1994 | — |
| 0 (this device) | K181865 | Acu-sInQ Complete Endoscope Cleaning Aid System | STERIS Corporation | 2018 | — |
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 FEB? 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 FEB device
- #1 K243433 enspire 3000 Cleaning and Liquid Chemical…score 10.8 · 9 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 |
|---|---|---|---|
| * | K914524 | Fluid Pump, CP #3Summary page 5…e Classification Number: 21 CFR 876.1500 Product Code: FEB 2. Predicate Device US Endoscopy Fluid Pump CP-3, cleared under K914524. 3. Description of Device The Acu-sInQ Complete Endoscope Cleaning Aid System is used in the reprocessing room of a… | 1994 |
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 |
|---|---|---|---|---|
| Oct 7, 2020 | Class III | Z-0458-2021 | Device Design | Potential for cleaning solution intrusion into endoscope |
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 K914524.
How does its category compare?
All FEB devicesFEB Accessories, Cleaning, For Endoscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · FEB
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · FEB
111in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FEB
15so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FEB
356in 2025
MAUDE reports naming product code FEB, 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 | — | 0 | 39 |
| 2008 | 1 | — | 3 | 152 |
| 2009 | 1 | — | 0 | 20 |
| 2010 | 2 | — | 1 | 50 |
| 2011 | 3 | 111 | 0 | 32 |
| 2012 | 1 | — | 0 | 16 |
| 2013 | 1 | — | 0 | 27 |
| 2014 | 1 | — | 0 | 48 |
| 2015 | 0 | — | 0 | 92 |
| 2016 | 2 | — | 2 | 103 |
| 2017 | 2 | — | 0 | 69 |
| 2018 | 1 | — | 0 | 88 |
| 2019 | 2 | — | 0 | 62 |
| 2020 | 2 | — | 1 | 426 |
| 2021 | 0 | — | 1 | 575 |
| 2022 | 1 | — | 0 | 607 |
| 2023 | 1 | — | 1 | 998 |
| 2024 | 2 | — | 1 | 884 |
| 2025 | 0 | — | 3 | 356 |
| 2026 | 1 | — | 15 | — |
What is it indicated for?
The Acu-sInQ Complete Endoscope Cleaning Aid System is intended to assist manual flexible endoscope cleaning according to the instructions provided by the endoscope manufacturer, by facilitating performance of a leak test, accurate detergent dosing with water temperature monitoring, channel flushing, rinsing, and process documentation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181865 · printed Nov 5, 2026
Cite this page
510(k) Report. “K181865: Acu-sInQ Complete Endoscope Cleaning Aid System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K181865
Report an extraction error
Are you the manufacturer?
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