510(k) · Cleared
ClearedKaltostat Wound Dressing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Calgon Vestal Div. · QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Cleared on Mar 20, 1991 after a 70-day review. The FDA summary names no predicate by number. 3 later devices descend from it.
- Decided
- Mar 20, 1991
- Review
- 70 days
- Class
- Class U
- Product code
- QSY
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 3 citing it directly.
- This deviceK910059 Kaltostat Wound DressingCalgon Vestal Div. · 1991
- Descendant · cites it directly · 0 of its ownK111578 Coreleader Colla-Algi Fiber Model CawCoreleader Biotech Co., Ltd. · 2011
- Descendant · cites it directly · 0 of its ownK102942 Coreleader Algiplaster Model AP 050501Coreleader Biotech Co., Ltd. · 2011
- Descendant · cites it directly · 0 of its ownK102943 Coreleader Algi-Fiber Wound Dressing Model Adw 05050Coreleader Biotech Co., Ltd. · 2011
Most influential descendants
Showing 3 of 3 · See all- K111578Coreleader Colla-Algi Fiber Model CawCoreleader Biotech Co., Ltd. · 2011 · cites it directly0descendants
- K102942Coreleader Algiplaster Model AP 050501Coreleader Biotech Co., Ltd. · 2011 · cites it directly0descendants
- K102943Coreleader Algi-Fiber Wound Dressing Model Adw 05050Coreleader Biotech Co., Ltd. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K910059 | Kaltostat Wound Dressing | Calgon Vestal Div. | 1991 | — |
| +1 | K111578 | Coreleader Colla-Algi Fiber Model Caw | Coreleader Biotech Co., Ltd. | 2011 | — |
| +1 | K102942 | Coreleader Algiplaster Model AP 050501 | Coreleader Biotech Co., Ltd. | 2011 | — |
| +1 | K102943 | Coreleader Algi-Fiber Wound Dressing Model Adw 05050 | Coreleader Biotech Co., Ltd. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 3 | 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 15.0 · 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?
The FDA summary names no predicate by number.
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K111578 (Coreleader Biotech Co., Ltd., 2011) has gone furthest, with 0 descendants of its own.
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.
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 | — |
https://510kreport.com/device/K910059 · printed Nov 6, 2026
Cite this page
510(k) Report. “K910059: Kaltostat Wound Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K910059
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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