510(k) · Cleared
ClearedAnsCare ChitoClot Pad
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Benq Materials Corporation · QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Cleared on Nov 5, 2015 as substantially equivalent to K032986 (Scion Cardio-Vascular, Inc., 2004) after a 209-day review. Its family tree reaches back 5 generations to 1991.
- Decided
- Nov 5, 2015
- Review
- 209 days
- Class
- Class U
- Product code
- QSY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K914575 (1991). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK914575 Sorbsan Topical Wound Dressing (Modified)Dow B. Hickam, Inc. · 1991
- 4 generations backK983210 Algisite MSmith & Nephew, Inc. · 1998
- 3 generations backK002896 Acticoat Foam Dressing, Algisite M Calcium Alginate DressingThe Westaim Corp. · 2001
- 2 generations backK024298 Antimicrobial Alginate DressingAdvanced Medical Solutions, Ltd. · 2003
- 1 generation backK032986 Clo-Surplusp.a.D.Scion Cardio-Vascular, Inc. · 2004
- This deviceK150963 AnsCare ChitoClot PadBenq Materials Corporation · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K914575 | Sorbsan Topical Wound Dressing (Modified) | Dow B. Hickam, Inc. | 1991 | — |
| −4 | K983210 | Algisite M | Smith & Nephew, Inc. | 1998 | — |
| −3 | K002896 | Acticoat Foam Dressing, Algisite M Calcium Alginate Dressing | The Westaim Corp. | 2001 | — |
| −2 | K024298 | Antimicrobial Alginate Dressing | Advanced Medical Solutions, Ltd. | 2003 | — |
| −1 | K032986 | Clo-Surplusp.a.D. | Scion Cardio-Vascular, Inc. | 2004 | — |
| 0 (this device) | K150963 | AnsCare ChitoClot Pad | Benq Materials Corporation | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 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 QSY? 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 QSY device
- #1 K240713 Traumagel®score 15.1 · 5 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 |
|---|---|---|---|
| * | K032986 | Clo-Surplusp.a.D.Summary page 5…mber: — Panel: General & Plastic Surgery Product Code: FRO 510(k) Number: K032986 BenQ Materials Corporation AnsCare ChitoClot Pad 510(k) Notification, K1509… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
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 24 years and passes through 6 companies; a new generation was cleared every 2.4 years on median.
- 1 of the 11 ancestors has a recall of any class.
- 6 other devices also cite its predicate K032986.
How does its category compare?
All QSY devicesQSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · QSY
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QSY
142in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QSY
No recall names QSY since 2007.
Adverse event reports per year · QSY
14in 2025
MAUDE reports naming product code QSY, 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 | 13 | 63 | 0 | 0 |
| 2008 | 7 | 61 | 0 | 0 |
| 2009 | 9 | 55 | 0 | 0 |
| 2010 | 7 | 75 | 0 | 0 |
| 2011 | 8 | 137 | 0 | 0 |
| 2012 | 7 | 239 | 0 | 0 |
| 2013 | 3 | 161 | 0 | 0 |
| 2014 | 6 | 249 | 0 | 0 |
| 2015 | 6 | 171 | 0 | 0 |
| 2016 | 5 | 161 | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 5 | 186 | 0 | 0 |
| 2019 | 4 | 336 | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 2 | — | 0 | 1 |
| 2023 | 7 | 586 | 0 | 0 |
| 2024 | 4 | 142 | 0 | 3 |
| 2025 | 2 | — | 0 | 14 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
AnsCare ChitoClot Pad is indicated for use of bleeding wound management. It promotes rapid control of wound bleeding and exudates absorption.
AnsCare ChitoClot Pad is indicated for use in wound management and to provide barrier to bacteria.
It is indicated for the following wounds, including lacerations, abrasions, hemodialysis wound and puncture sites for vascular procedures.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K150963 · printed Nov 4, 2026
Cite this page
510(k) Report. “K150963: AnsCare ChitoClot Pad.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K150963
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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