510(k) · Cleared
ClearedEndoClot
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Endoclot Plus Co., Ltd. · QAU Hemostatic Device For Endoscopic Gastrointestinal Use
Cleared on Jan 29, 2021 as substantially equivalent to DEN170015 (Wilson-Cook Medical, Inc., 2018) and 1 other predicate after a 686-day review. Its family tree reaches back 3 generations to 2005. 1 later device descends from it.
- Decided
- Jan 29, 2021
- Review
- 686 days
- Class
- Class II
- Product code
- QAU
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K042834 (2005). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK042834 Micromedics Fibrijet Air Assisted Endoscopic ApplicatorMicromedics, Inc. · 2005
- 2 generations backK123325 Medafor Direct Gas-Assisted Application SystemMedafor, Inc. · 2013
- 1 generation backK162197 EndoClotEndoclot Plus Co., Ltd. · 2017
- This deviceK190677 EndoClotEndoclot Plus Co., Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK234131 Resolv Endoscopic Hemostat SystemHemostasis, LLC · 2024
Most influential descendants
Showing 1 of 1 · See all- K234131Resolv Endoscopic Hemostat SystemHemostasis, LLC · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K042834 | Micromedics Fibrijet Air Assisted Endoscopic Applicator | Micromedics, Inc. | 2005 | — |
| −2 | K123325 | Medafor Direct Gas-Assisted Application System | Medafor, Inc. | 2013 | — |
| −1 | K162197 | EndoClot | Endoclot Plus Co., Ltd. | 2017 | — |
| 0 (this device) | K190677 | EndoClot | Endoclot Plus Co., Ltd. | 2021 | — |
| +1 | K234131 | Resolv Endoscopic Hemostat System | Hemostasis, LLC | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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? (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 |
|---|---|---|---|
| * | DEN170015 | Hemospray Endoscopic HemostatSummary page 4…e Device(s) The identified predicates within this submission are as follows: The Hemospray® Endoscopic Hemostat (Hemospray®) has been cleared by FDA through De Novo No. DEN170015 (Date: May 7, 2018). The EndoClot® Applicator has been cleared by FDA through 510(k) No. K162197 (Date: January 18, 2017). ===… | 2018 |
| * | K162197 | EndoClotSummary page 4…pic Hemostat (Hemospray®) has been cleared by FDA through De Novo No. DEN170015 (Date: May 7, 2018). The EndoClot® Applicator has been cleared by FDA through 510(k) No. K162197 (Date: January 18, 2017). K1906… | 2017 |
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 |
|---|---|---|---|
| K234131 | Resolv Endoscopic Hemostat System | 2024 | 0 |
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?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 4.0 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K234131 (Hemostasis, LLC, 2024) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate DEN170015.
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. 2021, 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?
EndoClot® PHS is used for hemostasis of nonvariceal gastrointestinal bleeding, excluding Forrest Ia classification of bleeding.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190677 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190677: EndoClot.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190677
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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