510(k) · Cleared
ClearedChitogauze
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hem Con Medical Technologies, Inc. · QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Cleared on Nov 17, 2010 as substantially equivalent to K090026 (Hem Con Medical Technologies, Inc., 2009) and 1 other predicate after a 75-day review. Its family tree reaches back 8 generations to 2000. 9 later devices descend from it.
- Decided
- Nov 17, 2010
- Review
- 75 days
- Class
- Class U
- Product code
- QSY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K002550 (2000). 17 ancestors in all, the oldest K821150 (1982). 9 later devices descend from it, 3 citing it directly.
- Root · 8 generations backK002550 RDH BandageMarine Polymer Technologies, Inc. · 2000
- 7 generations backK013390 QuickclotOn Site Gas Systems, Inc. · 2002
- 6 generations backK051955 Quickclot Acs - Accelerated Clotting SpongeZ-Medica Corporation · 2005
- 5 generations backK061767 Quikclot 1ST Response & Quikclot Acs+Z-Medica Corporation · 2006
- 4 generations backK070010 Quikclot Sport and Quikclot Sport SilverZ-Medica Corporation · 2007
- 3 generations backK072474 Quikclot EXZ-Medica Corporation · 2007 · Recalled
- 2 generations backK090026 Chitogauze, Models 130, 131, 263, 264, 265, 266Hem Con Medical Technologies, Inc. · 2009
- 1 generation backK092357 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
- This deviceK102546 ChitogauzeHem Con Medical Technologies, Inc. · 2010
- Descendant · cites it directly · 4 of its ownK142363 Nustat, Nustat XRBeeken Biomedical · 2015
- Descendant · 2 generations on · 2 of its ownK222189 SiOxD Wound MatrixSioxmed, LLC · 2022
- Descendant · cites it directly · 2 of its ownK153582 Prometheus ChitoGauze XR PROHem Con Medical Technologies, Inc. · 2016
- Descendant · 3 generations on · 1 of its ownK232847 SiOxD Wound MatrixSioxmed, LLC · 2023
- Descendant · 3 generations on · 0 of its ownK241660 SiOxD® Wound MatrixSioxmed, LLC · 2024
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K142363Nustat, Nustat XRBeeken Biomedical · 2015 · cites it directly4descendants
- K222189SiOxD Wound MatrixSioxmed, LLC · 2022 · 2 generations on2descendants
- K153582Prometheus ChitoGauze XR PROHem Con Medical Technologies, Inc. · 2016 · cites it directly2descendants
- K232847SiOxD Wound MatrixSioxmed, LLC · 2023 · 3 generations on1descendant
- K241660SiOxD® Wound MatrixSioxmed, LLC · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K002550 | RDH Bandage | Marine Polymer Technologies, Inc. | 2000 | — |
| −7 | K013390 | Quickclot | On Site Gas Systems, Inc. | 2002 | — |
| −6 | K051955 | Quickclot Acs - Accelerated Clotting Sponge | Z-Medica Corporation | 2005 | — |
| −5 | K061767 | Quikclot 1ST Response & Quikclot Acs+ | Z-Medica Corporation | 2006 | — |
| −4 | K070010 | Quikclot Sport and Quikclot Sport Silver | Z-Medica Corporation | 2007 | — |
| −3 | K072474 | Quikclot EX | Z-Medica Corporation | 2007 | 1 |
| −2 | K090026 | Chitogauze, Models 130, 131, 263, 264, 265, 266 | Hem Con Medical Technologies, Inc. | 2009 | — |
| −1 | 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 | — |
| 0 (this device) | K102546 | Chitogauze | Hem Con Medical Technologies, Inc. | 2010 | — |
| +1 | K142363 | Nustat, Nustat XR | Beeken Biomedical | 2015 | — |
| +2 | K222189 | SiOxD Wound Matrix | Sioxmed, LLC | 2022 | — |
| +1 | K153582 | Prometheus ChitoGauze XR PRO | Hem Con Medical Technologies, Inc. | 2016 | — |
| +3 | K232847 | SiOxD Wound Matrix | Sioxmed, LLC | 2023 | — |
| +3 | K241660 | SiOxD® Wound Matrix | Sioxmed, LLC | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 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 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? (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 |
|---|---|---|---|
| * | K090026 | Chitogauze, Models 130, 131, 263, 264, 265, 266Summary page 5…ssing Classification Name: Dressing Product Code: FRO Predicate Device(s): Modification to ChitoGauze" 4 (K090026, K092357) Company Name: HemnCon Medical Technologies, Inc. Com… | 2009 |
| * | 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 in, 8PLY…Summary page 5…ssing Product Code: FRO Predicate Device(s): Modification to ChitoGauze" 4 (K090026, K092357) Company Name: HemnCon Medical Technologies, Inc. Company Address: 10575 SW Cas… | 2009 |
What descends from it? (9)
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?
- The line of descent spans 10 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 2 of the 17 ancestors have a recall of any class.
- Of its descendants, K142363 (Beeken Biomedical, 2015) has gone furthest, with 4 descendants of its own.
- 6 other devices also cite its predicate K090026.
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. 2010, 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?
ChitoGauze TM XR is a hemostatic dressing for the external, temporary control of
severely bleeding wounds.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102546 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102546: Chitogauze.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102546
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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