510(k) · Cleared
Recalled · Class II · 2024Hemospray Endoscopic Hemostat
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 10, 2020 as substantially equivalent to DEN170015 (Wilson-Cook Medical, Inc., 2018) after a 58-day review. Its family tree reaches back 1 generation to 2018. 1 later device descends from it. It has been recalled 3 times.
- Decided
- Jun 10, 2020
- Review
- 58 days
- Class
- Class II
- Product code
- QAU
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN170015 (2018). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backDEN170015 Hemospray Endoscopic HemostatWilson-Cook Medical, Inc. · 2018
- This deviceK200972 Hemospray Endoscopic HemostatWilson-Cook Medical, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK253302 Hemospray Endoscopic Hemostat (HEMO-[X])Wilson-Cook Medical, Inc. · 2026 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K253302Hemospray Endoscopic Hemostat (HEMO-[X])Wilson-Cook Medical, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN170015 | Hemospray Endoscopic Hemostat | Wilson-Cook Medical, Inc. | 2018 | — |
| 0 (this device) | K200972 | Hemospray Endoscopic Hemostat | Wilson-Cook Medical, Inc. | 2020 | — |
| +1 | K253302 | Hemospray Endoscopic Hemostat (HEMO-[X]) | Wilson-Cook Medical, Inc. | 2026 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 1 | 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 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 |
|---|---|---|---|
| * | DEN170015 | Hemospray Endoscopic HemostatSummary page 4…: Hemostasis Device for intraluminal gastrointestinal use 21 CFR 878.4456, QAU, Class II Predicate Device: Hemospray Endoscopic Hemostat, DEN 170015 Intended Use: The COOK Hemospray device is intended for hemostasis of non-variceal bleeds in th… | 2018 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K253302 | Hemospray Endoscopic Hemostat (HEMO-[X]) | 2026 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 29, 2024 | Class II | Z-0036-2025 | Nonconforming Material/Component | Specific lots of product have been manufactured with nonconforming raw materials. |
| May 22, 2023 | Class II | Z-1978-2023 | Under Investigation by firm | There are potential risks of the Hemospray powder adhering to the distal end of the endoscope, which can result in adhesion of the endoscope to tissue and consequent difficulty or inability to maneuver/remove the endoscope. |
| May 22, 2023 | Class II | Z-1979-2023 | Under Investigation by firm | There are potential risks of the Hemospray powder adhering to the distal end of the endoscope, which can result in adhesion of the endoscope to tissue and consequent difficulty or inability to maneuver/remove the endoscope. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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. 2020, 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 COOK Hemospray device is intended for hemostasis of non-variceal bleeds in the GI (gastrointestinal) tract. It is for prescription use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200972 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200972: Hemospray Endoscopic Hemostat.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200972
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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