510(k) · Cleared
ClearedAnsCare ChitoClot Gauze (prescription use), AnsCare ChitoClot Gauze (over-the-counter use)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Benq Materials Corporation · QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Cleared on May 8, 2015 as substantially equivalent to K133121 (Sam Medical Products, 2014) and 2 other predicates after a 155-day review. Its family tree reaches back 9 generations to 2000. 2 later devices descend from it.
- Decided
- May 8, 2015
- Review
- 155 days
- Class
- Class U
- Product code
- QSY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K002550 (2000). 25 ancestors in all, the oldest K821150 (1982). 2 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK002550 RDH BandageMarine Polymer Technologies, Inc. · 2000
- 5 generations between
- 3 generations backK090026 Chitogauze, Models 130, 131, 263, 264, 265, 266Hem Con Medical Technologies, Inc. · 2009
- 2 generations backK091795 Medtrade Products Celox Trauma GauzeMedtrade Products, Ltd. · 2009
- 1 generation backK133121 Chito-Sam 100,4IN X4IN,Chito-Sam, 3IN X6FT, Chito-Sam 100,3IN X10FT…Sam Medical Products · 2014
- This deviceK143462 AnsCare ChitoClot Gauze (prescription use), AnsCare ChitoClot Gauze…Benq Materials Corporation · 2015
- Descendant · cites it directly · 0 of its ownK222909 Axiostat GauzeAdvamedica, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK172155 StatGuard Hemostatic Patch, StatGuard Hemostatic DressingStatguard, LLC · 2018
Show all 9 generations
- Root · 9 generations backK002550 RDH BandageMarine Polymer Technologies, Inc. · 2000
- 8 generations backK013390 QuickclotOn Site Gas Systems, Inc. · 2002
- 7 generations backK051955 Quickclot Acs - Accelerated Clotting SpongeZ-Medica Corporation · 2005
- 6 generations backK061767 Quikclot 1ST Response & Quikclot Acs+Z-Medica Corporation · 2006
- 5 generations backK070010 Quikclot Sport and Quikclot Sport SilverZ-Medica Corporation · 2007
- 4 generations backK072474 Quikclot EXZ-Medica Corporation · 2007 · Recalled
- 3 generations backK090026 Chitogauze, Models 130, 131, 263, 264, 265, 266Hem Con Medical Technologies, Inc. · 2009
- 2 generations backK091795 Medtrade Products Celox Trauma GauzeMedtrade Products, Ltd. · 2009
- 1 generation backK133121 Chito-Sam 100,4IN X4IN,Chito-Sam, 3IN X6FT, Chito-Sam 100,3IN X10FT…Sam Medical Products · 2014
- This deviceK143462 AnsCare ChitoClot Gauze (prescription use), AnsCare ChitoClot Gauze…Benq Materials Corporation · 2015
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K002550 | RDH Bandage | Marine Polymer Technologies, Inc. | 2000 | — |
| −8 | K013390 | Quickclot | On Site Gas Systems, Inc. | 2002 | — |
| −7 | K051955 | Quickclot Acs - Accelerated Clotting Sponge | Z-Medica Corporation | 2005 | — |
| −6 | K061767 | Quikclot 1ST Response & Quikclot Acs+ | Z-Medica Corporation | 2006 | — |
| −5 | K070010 | Quikclot Sport and Quikclot Sport Silver | Z-Medica Corporation | 2007 | — |
| −4 | K072474 | Quikclot EX | Z-Medica Corporation | 2007 | 1 |
| −3 | K090026 | Chitogauze, Models 130, 131, 263, 264, 265, 266 | Hem Con Medical Technologies, Inc. | 2009 | — |
| −2 | K091795 | Medtrade Products Celox Trauma Gauze | Medtrade Products, Ltd. | 2009 | — |
| −1 | K133121 | Chito-Sam 100,4IN X4IN,Chito-Sam, 3IN X6FT, Chito-Sam 100,3IN X10FT, Chito-Sam… | Sam Medical Products | 2014 | — |
| 0 (this device) | K143462 | AnsCare ChitoClot Gauze (prescription use), AnsCare ChitoClot Gauze… | Benq Materials Corporation | 2015 | — |
| +1 | K222909 | Axiostat Gauze | Advamedica, Inc. | 2023 | — |
| +1 | K172155 | StatGuard Hemostatic Patch, StatGuard Hemostatic Dressing | Statguard, LLC | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2023 | 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? (3)
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 |
|---|---|---|---|
| * | K133121 | Chito-Sam 100,4IN X4IN,Chito-Sam, 3IN X6FT, Chito-Sam 100,3IN X10FT, Chito-Sam Active…Summary page 6…uct Code: FRO 5.5 Identification of the Predicate Device: Predicate Device Name: Chito-SAM™ Gauze Manufacturer: SAM Medical Products Product Code: FRO 510(k) Number: K133121 Predicate Device Name: CELOX Gauze PRO Manufacturer: Product Code: MedTrade Products Ltd. FRO BenQ Materials… | 2014 |
| * | K113560 | Celox Gauze ProSummary page 7…auze PRO Manufacturer: Product Code: MedTrade Products Ltd. FRO BenQ Materials Corporation AnsCare ChitoClot Gauze 510(k) Notification 510(k) Number: K113560 Predicate Device Name: CELOX Hemostatic Granules on Sheet Manufacturer: MedTrade Products Ltd. Product Code: FRO 510(k) Number… | 2012 |
| * | K080097 | Medtrade Products Celox Hemostatic Granules on SheetSummary page 7…) Notification 510(k) Number: K113560 Predicate Device Name: CELOX Hemostatic Granules on Sheet Manufacturer: MedTrade Products Ltd. Product Code: FRO 510(k) Number: K080097 5.6 Intended Use and Indications for Use of the subject device. AnsCare ChitoClot Gauze (prescription use): For use as a tempor… | 2008 |
What descends from it? (2)
2 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 15 years and passes through 7 companies; a new generation was cleared every 12 months on median.
- 2 of the 25 ancestors have a recall of any class.
- Of its descendants, K222909 (Advamedica, Inc., 2023) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K133121.
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. 2015, 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?
AnsCare ChitoClot Gauze (prescription use):
For use as a temporary external dressing to control moderate to severe bleeding and manage external abrasions, lacerations.
AnsCare ChitoClot Gauze (over-the-counter use):
To control bleeding of lacerations, minor cuts and abrasions,
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/K143462 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143462: AnsCare ChitoClot Gauze (prescription use), AnsCare ChitoClot Gauze (over-the-counter use).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143462
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