510(k) · Cleared
ClearedSorbastace
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hemostace, LLC · QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Cleared on Apr 9, 1998 after a 478-day review. The FDA summary names its predicate without a number. 52 later devices descend from it.
- Decided
- Apr 9, 1998
- Review
- 478 days
- Class
- Class U
- Product code
- QSY
- Recalls
- None
- Predicates
- 0
52 later devices descend from it, 2 citing it directly.
- This deviceK965034 SorbastaceHemostace, LLC · 1998
- Descendant · cites it directly · 40 of its ownK021581 HemosorbOn Site Gas Systems, Inc. · 2002
- Descendant · 2 generations on · 38 of its ownK070010 Quikclot Sport and Quikclot Sport SilverZ-Medica Corporation · 2007
- Descendant · 3 generations on · 36 of its ownK072474 Quikclot EXZ-Medica Corporation · 2007 · Recalled
- Descendant · 4 generations on · 20 of its ownK090026 Chitogauze, Models 130, 131, 263, 264, 265, 266Hem Con Medical Technologies, Inc. · 2009
- Descendant · cites it directly · 17 of its ownK070520 Pro QR (Quick Relief) Powder (for Minor External Bleeding From…Biolife, LLC · 2007
Showing 5 of 52 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 52 · See all- K021581HemosorbOn Site Gas Systems, Inc. · 2002 · cites it directly40descendants
- K070010Quikclot Sport and Quikclot Sport SilverZ-Medica Corporation · 2007 · 2 generations on38descendants
- K072474Quikclot EXZ-Medica Corporation · 2007 · 3 generations on36descendants
- K090026Chitogauze, Models 130, 131, 263, 264, 265, 266Hem Con Medical Technologies, Inc. · 2009 · 4 generations on20descendants
- K070520Pro QR (Quick Relief) Powder (for Minor External Bleeding From Wounds & Procedures)Biolife, LLC · 2007 · cites it directly17descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K965034 | Sorbastace | Hemostace, LLC | 1998 | — |
| +1 | K021581 | Hemosorb | On Site Gas Systems, Inc. | 2002 | — |
| +2 | K070010 | Quikclot Sport and Quikclot Sport Silver | Z-Medica Corporation | 2007 | — |
| +3 | K072474 | Quikclot EX | Z-Medica Corporation | 2007 | 1 |
| +4 | K090026 | Chitogauze, Models 130, 131, 263, 264, 265, 266 | Hem Con Medical Technologies, Inc. | 2009 | — |
| +1 | K070520 | Pro QR (Quick Relief) Powder (for Minor External Bleeding From Wounds &… | Biolife, LLC | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 5 | 0 |
| 2010 | 4 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 4 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 5 | 0 |
| 2024 | 3 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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? (5)
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 |
|---|---|---|---|
| * | — | Iodosorb Powder Named without a submission number | |
| * | — | Intrasite Cavity Wound Dressing Named without a submission number | |
| * | — | Kaltostat Wound Dressing Named without a submission number | |
| * | — | ClearSite Hydrogel Wound Dressing Named without a submission number | |
| * | — | DeRoyal Hydrogel Dressing Named without a submission number |
What descends from it? (52)
See all 522 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, K021581 (On Site Gas Systems, Inc., 2002) has gone furthest, with 40 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 | — |
What is it indicated for?
Sorbastace is indicated for use to absorb body fluid and to stop minor bleeding in
fresh traumatic superficial lacerations or wounds. Once exudation and bleeding
has stopped, it is irrigated from the wound and a protective dressing can be
applied. It is intended to be distributed as an Over-The-Counter (OTC) device.
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/K965034 · printed Nov 6, 2026
Cite this page
510(k) Report. “K965034: Sorbastace.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K965034
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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