510(k) · Cleared
ClearedMedtrade Products Celox Hemostatic Granules on Sheet
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtrade Products, Ltd. · QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Cleared on Jul 9, 2008 as substantially equivalent to K061079 (Medtrade Products, Ltd., 2006) after a 177-day review. Its family tree reaches back 3 generations to 2000. 18 later devices descend from it.
- Decided
- Jul 9, 2008
- Review
- 177 days
- Class
- Class U
- Product code
- QSY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K002550 (2000). 5 ancestors in all, the oldest K972914 (1997). 18 later devices descend from it, 6 citing it directly.
- Root · 3 generations backK002550 RDH BandageMarine Polymer Technologies, Inc. · 2000
- 2 generations backK013390 QuickclotOn Site Gas Systems, Inc. · 2002
- 1 generation backK061079 Medtrade Products Celox Topical Hemostatic Granules, Medtrade…Medtrade Products, Ltd. · 2006
- This deviceK080097 Medtrade Products Celox Hemostatic Granules on SheetMedtrade Products, Ltd. · 2008
- Descendant · cites it directly · 11 of its ownK113560 Celox Gauze ProMedtrade Products, Ltd. · 2012
- Descendant · cites it directly · 7 of its ownK091795 Medtrade Products Celox Trauma GauzeMedtrade Products, Ltd. · 2009
- Descendant · cites it directly · 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 · 2 of its ownK240713 Traumagel®Cresilon, Inc. · 2024
- Descendant · cites it directly · 2 of its ownK143462 AnsCare ChitoClot Gauze (prescription use), AnsCare ChitoClot Gauze…Benq Materials Corporation · 2015
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K113560Celox Gauze ProMedtrade Products, Ltd. · 2012 · cites it directly11descendants
- 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 · cites it directly5descendants
- K240713Traumagel®Cresilon, Inc. · 2024 · 2 generations on2descendants
- K143462AnsCare ChitoClot Gauze (prescription use), AnsCare ChitoClot Gauze (over-the-counter use)Benq Materials Corporation · 2015 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K002550 | RDH Bandage | Marine Polymer Technologies, Inc. | 2000 | — |
| −2 | K013390 | Quickclot | On Site Gas Systems, Inc. | 2002 | — |
| −1 | K061079 | Medtrade Products Celox Topical Hemostatic Granules, Medtrade Products Celox… | Medtrade Products, Ltd. | 2006 | — |
| 0 (this device) | K080097 | Medtrade Products Celox Hemostatic Granules on Sheet | Medtrade Products, Ltd. | 2008 | — |
| +1 | K113560 | Celox Gauze Pro | Medtrade Products, Ltd. | 2012 | — |
| +1 | 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 | — |
| +2 | K240713 | Traumagel® | Cresilon, Inc. | 2024 | — |
| +1 | K143462 | AnsCare ChitoClot Gauze (prescription use), AnsCare ChitoClot Gauze… | Benq Materials Corporation | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K061079 | Medtrade Products Celox Topical Hemostatic Granules, Medtrade Products Celox 762…Summary page 6…General Description The MeldTrade ProCu¢Ls CLL©X Hemostatic Granules on Sheet is nearly identical to the legally marketed Mea f'rade Products CELOX Hemostatic Granules (K061079, cleared April 20, 2006) m product design composition and processing in that the same CELOX Hemostatic Granules are mechanically… | 2006 |
| † | K071519 | Hemcon Chitoflex-Surgical Dressing | 2007 |
| † | K032986 | Clo-Surplusp.a.D. | 2004 |
What descends from it? (18)
See all 186 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K113560 | Celox Gauze Pro | 2012 | 11 |
| K091795 | Medtrade Products Celox Trauma Gauze | 2009 | 7 |
| K133121 | Chito-Sam 100,4IN X4IN,Chito-Sam, 3IN X6FT, Chito-Sam 100,3IN X10FT, Chito-Sam Active… | 2014 | 5 |
| K143462 | AnsCare ChitoClot Gauze (prescription use), AnsCare ChitoClot Gauze (over-the-counter use) | 2015 | 2 |
| K093519 | Medtrade Products Celox Vascular Topical Hemostatic Granules on Sheet | 2010 | 2 |
| K110386 | Celox Rapid Gauze | 2011 | 1 |
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 8 years and passes through 3 companies; a new generation was cleared every 2.1 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K113560 (Medtrade Products, Ltd., 2012) has gone furthest, with 11 descendants of its own.
- 6 other devices also cite its predicate K061079.
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. 2008, 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?
MedTrade Products CELOX Hemostatic Granules on Sheet is indicated for temporary external use to control moderate to severe bleeding
MedTrade Products CELOX Hemostatic Granules on Sheet is indicated for temporary external use to control bleeding of lacerations, minor cuts, and abrasions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080097 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080097: Medtrade Products Celox Hemostatic Granules on Sheet.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080097
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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