510(k) · Cleared
Recalled · Class II · 2026Hemospray Endoscopic Hemostat (HEMO-[X])
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wilson-Cook Medical, Inc. · QAU Hemostatic Device For Endoscopic Gastrointestinal Use
Cleared on Jun 2, 2026 as substantially equivalent to K200972 (Wilson-Cook Medical, Inc., 2020) after a 246-day review. Its family tree reaches back 2 generations to 2018. It has been recalled once.
- Decided
- Jun 2, 2026
- Review
- 246 days
- Class
- Class II
- Product code
- QAU
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN170015 (2018). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 QAU? 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 QAU device
- #1 K242250 PuraStatscore 14.8 · 3 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 |
|---|---|---|---|
| * | K200972 | Hemospray Endoscopic HemostatSummary page 5…Regulation Class: Class II; Regulation Number 21 CFR 878.4456 Product Code: QAU III. Predicate Device Hemospray® Endoscopic Hemostat (K200972), manufactured by Wilson-Cook Medical, Inc. IV. Device Description The Hemospray® Endoscopic Hemostat is an inert bentonite pow… | 2020 |
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 20, 2026 | Class II | Z-3177-2026 | Labeling design | Due to issue with endoscope adherence and inability to spray powder. Firm will provide an updated Instruction for Use (IFU). |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 8 years and passes through 1 company; a new generation was cleared every 6.0 years on median.
- 1 of the 2 ancestors has a recall of any class.
How does its category compare?
All QAU devicesQAU Hemostatic Device For Endoscopic Gastrointestinal Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · QAU
3in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · QAU
211in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QAU
2in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QAU
121in 2025
MAUDE reports naming product code QAU, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 56 |
| 2019 | 0 | — | 0 | 218 |
| 2020 | 1 | — | 0 | 73 |
| 2021 | 2 | — | 0 | 112 |
| 2022 | 1 | — | 0 | 135 |
| 2023 | 1 | — | 0 | 132 |
| 2024 | 3 | 211 | 2 | 154 |
| 2025 | 0 | — | 0 | 121 |
| 2026 | 3 | 89 | 1 | — |
What is it indicated for?
The Hemospray® Endoscopic Hemostat is used in adult patients for the hemostasis of nonvariceal gastrointestinal bleeding due to endoscopic procedures and medical conditions such as inflammatory lesions, GI vascular abnormalities, tumors, and ulcers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253302 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253302: Hemospray Endoscopic Hemostat (HEMO-[X]).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253302
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026