510(k) · Cleared
ClearedHemosorb
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
On Site Gas Systems, Inc. · QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Cleared on Jul 12, 2002 as substantially equivalent to K965034 (Hemostace, LLC, 1998) after a 59-day review. Its family tree reaches back 1 generation to 1998. 40 later devices descend from it.
- Decided
- Jul 12, 2002
- Review
- 59 days
- Class
- Class U
- Product code
- QSY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K965034 (1998). 40 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK965034 SorbastaceHemostace, LLC · 1998
- This deviceK021581 HemosorbOn Site Gas Systems, Inc. · 2002
- Descendant · cites it directly · 38 of its ownK070010 Quikclot Sport and Quikclot Sport SilverZ-Medica Corporation · 2007
- Descendant · 2 generations on · 36 of its ownK072474 Quikclot EXZ-Medica Corporation · 2007 · Recalled
- Descendant · 3 generations on · 20 of its ownK090026 Chitogauze, Models 130, 131, 263, 264, 265, 266Hem Con Medical Technologies, Inc. · 2009
- Descendant · 4 generations on · 10 of its ownK092357 Chitogauze,2 in X 2 in,8 Ply, 4 in X 4 in 8 Ply, 4 in X 8 in, 8PLY…Hem Con Medical Technologies, Inc. · 2009
- Descendant · 4 generations on · 9 of its ownK102546 ChitogauzeHem Con Medical Technologies, Inc. · 2010
Showing 5 of 40 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 40 · See all- K070010Quikclot Sport and Quikclot Sport SilverZ-Medica Corporation · 2007 · cites it directly38descendants
- K072474Quikclot EXZ-Medica Corporation · 2007 · 2 generations on36descendants
- K090026Chitogauze, Models 130, 131, 263, 264, 265, 266Hem Con Medical Technologies, Inc. · 2009 · 3 generations on20descendants
- K092357Chitogauze,2 in X 2 in,8 Ply, 4 in X 4 in 8 Ply, 4 in X 8 in, 8PLY, 1 in X 4 in, 8PLY…Hem Con Medical Technologies, Inc. · 2009 · 4 generations on10descendants
- K102546ChitogauzeHem Con Medical Technologies, Inc. · 2010 · 4 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K965034 | Sorbastace | Hemostace, LLC | 1998 | — |
| 0 (this device) | K021581 | Hemosorb | On Site Gas Systems, Inc. | 2002 | — |
| +1 | K070010 | Quikclot Sport and Quikclot Sport Silver | Z-Medica Corporation | 2007 | — |
| +2 | K072474 | Quikclot EX | Z-Medica Corporation | 2007 | 1 |
| +3 | K090026 | Chitogauze, Models 130, 131, 263, 264, 265, 266 | Hem Con Medical Technologies, Inc. | 2009 | — |
| +4 | K092357 | Chitogauze,2 in X 2 in,8 Ply, 4 in X 4 in 8 Ply, 4 in X 8 in, 8PLY, 1 in X 4… | Hem Con Medical Technologies, Inc. | 2009 | — |
| +4 | K102546 | Chitogauze | Hem Con Medical Technologies, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 4 | 0 |
| 2010 | 3 | 0 |
| 2011 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 3 | 0 |
| 2018 | 4 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 5 | 0 |
| 2024 | 2 | 0 |
| 2026 | 2 | 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? (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 |
|---|---|---|---|
| * | K965034 | SorbastaceSummary page 6…eral and Plastic Surgery Common Name Traumatic Wound Dressing Predicate Device Sorbastace K-965034 Company: Hemostace . Contact Person Bart Gullong, Vice-president… | 1998 |
What descends from it? (40)
See all 402 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?
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?
Hemosorb is intended as a topical dressing for the local management of bleeding wounds such as minor cuts, lacerations, and abrasions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021581 · printed Nov 5, 2026
Cite this page
510(k) Report. “K021581: Hemosorb.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K021581
Report an extraction error
Are you the manufacturer?
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