510(k) · Cleared
ClearedChitogauze, Models 130, 131, 263, 264, 265, 266
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 Mar 31, 2009 as substantially equivalent to K072486 (Hem Con Medical Technologies, Inc., 2008) and 1 other predicate after an 85-day review. Its family tree reaches back 6 generations to 2000. 20 later devices descend from it.
- Decided
- Mar 31, 2009
- Review
- 85 days
- Class
- Class U
- Product code
- QSY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K002550 (2000). 15 ancestors in all, the oldest K821150 (1982). 20 later devices descend from it, 7 citing it directly.
- Root · 6 generations backK002550 RDH BandageMarine Polymer Technologies, Inc. · 2000
- 5 generations backK013390 QuickclotOn Site Gas Systems, Inc. · 2002
- 4 generations backK051955 Quickclot Acs - Accelerated Clotting SpongeZ-Medica Corporation · 2005
- 3 generations backK061767 Quikclot 1ST Response & Quikclot Acs+Z-Medica Corporation · 2006
- 2 generations backK070010 Quikclot Sport and Quikclot Sport SilverZ-Medica Corporation · 2007
- 1 generation backK072474 Quikclot EXZ-Medica Corporation · 2007 · Recalled
- This deviceK090026 Chitogauze, Models 130, 131, 263, 264, 265, 266Hem Con Medical Technologies, Inc. · 2009
- Descendant · cites it directly · 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 · cites it directly · 9 of its ownK102546 ChitogauzeHem Con Medical Technologies, Inc. · 2010
- Descendant · cites it directly · 7 of its ownK091795 Medtrade Products Celox Trauma GauzeMedtrade Products, Ltd. · 2009
- Descendant · 2 generations on · 5 of its ownK133121 Chito-Sam 100,4IN X4IN,Chito-Sam, 3IN X6FT, Chito-Sam 100,3IN X10FT…Sam Medical Products · 2014
- Descendant · 2 generations on · 4 of its ownK142363 Nustat, Nustat XRBeeken Biomedical · 2015
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- 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 · cites it directly10descendants
- K102546ChitogauzeHem Con Medical Technologies, Inc. · 2010 · cites it directly9descendants
- K091795Medtrade Products Celox Trauma GauzeMedtrade Products, Ltd. · 2009 · cites it directly7descendants
- K133121Chito-Sam 100,4IN X4IN,Chito-Sam, 3IN X6FT, Chito-Sam 100,3IN X10FT, Chito-Sam Active…Sam Medical Products · 2014 · 2 generations on5descendants
- K142363Nustat, Nustat XRBeeken Biomedical · 2015 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K002550 | RDH Bandage | Marine Polymer Technologies, Inc. | 2000 | — |
| −5 | K013390 | Quickclot | On Site Gas Systems, Inc. | 2002 | — |
| −4 | K051955 | Quickclot Acs - Accelerated Clotting Sponge | Z-Medica Corporation | 2005 | — |
| −3 | K061767 | Quikclot 1ST Response & Quikclot Acs+ | Z-Medica Corporation | 2006 | — |
| −2 | K070010 | Quikclot Sport and Quikclot Sport Silver | Z-Medica Corporation | 2007 | — |
| −1 | K072474 | Quikclot EX | Z-Medica Corporation | 2007 | 1 |
| 0 (this device) | 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 | — |
| +1 | K102546 | Chitogauze | Hem Con Medical Technologies, Inc. | 2010 | — |
| +1 | K091795 | Medtrade Products Celox Trauma Gauze | Medtrade Products, Ltd. | 2009 | — |
| +2 | K133121 | Chito-Sam 100,4IN X4IN,Chito-Sam, 3IN X6FT, Chito-Sam 100,3IN X10FT, Chito-Sam… | Sam Medical Products | 2014 | — |
| +2 | K142363 | Nustat, Nustat XR | Beeken Biomedical | 2015 | — |
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 |
|---|---|---|
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 4 | 0 |
| 2024 | 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 15.1 · 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? (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 |
|---|---|---|---|
| * | K072486 | Modification to Hemcon Bandage and Hemcon Bandage OtcSummary page 5…Wound Dressing Classification Name: Dressing Product Code: FRO Predicate Device(s): Hem~ono Bandage (K072486) Quik~lot® eX TM (K072474) Company Name: Hem~on Medical Techn… | 2008 |
| * | K072474 | Quikclot EXSummary page 5…Product Code: FRO Predicate Device(s): Hem~ono Bandage (K072486) Quik~lot® eX TM (K072474) Company Name: Hem~on Medical Technologies, Inc. Company Address: 10575 SW Cas… | 2007 |
What descends from it? (20)
See all 207 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| 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… | 2009 | 10 |
| K102546 | Chitogauze | 2010 | 9 |
| K091795 | Medtrade Products Celox Trauma Gauze | 2009 | 7 |
| K153582 | Prometheus ChitoGauze XR PRO | 2016 | 2 |
| K213413 | Hemostatic Dressing | 2023 | 0 |
| K172155 | StatGuard Hemostatic Patch, StatGuard Hemostatic Dressing | 2018 | 0 |
| K111163 | Chitogauze Fusion | 2011 | 0 |
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 9 years and passes through 4 companies; a new generation was cleared every 1.4 years on median.
- 2 of the 15 ancestors have a recall of any class.
- Of its descendants, K092357 (Hem Con Medical Technologies, Inc., 2009) has gone furthest, with 10 descendants of its own.
- 3 other devices also cite its predicate K072486.
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. 2009, 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 is a hemostatic dressing for the external, temporary control of severely bleeding wounds.
ChitoGauze is intended for temporary external use to stop bleeding of minor wounds, minor cuts and minor abrasions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090026 · printed Nov 4, 2026
Cite this page
510(k) Report. “K090026: Chitogauze, Models 130, 131, 263, 264, 265, 266.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K090026
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