510(k) · Cleared
ClearedCelox Gauze Pro
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 Aug 1, 2012 as substantially equivalent to K080097 (Medtrade Products, Ltd., 2008) and 1 other predicate after a 244-day review. Its family tree reaches back 4 generations to 2000. 11 later devices descend from it.
- Decided
- Aug 1, 2012
- Review
- 244 days
- Class
- Class U
- Product code
- QSY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K002550 (2000). 11 ancestors in all, the oldest K972914 (1997). 11 later devices descend from it, 5 citing it directly.
- Root · 4 generations backK002550 RDH BandageMarine Polymer Technologies, Inc. · 2000
- 3 generations backK013390 QuickclotOn Site Gas Systems, Inc. · 2002
- 2 generations backK061079 Medtrade Products Celox Topical Hemostatic Granules, Medtrade…Medtrade Products, Ltd. · 2006
- 1 generation backK080097 Medtrade Products Celox Hemostatic Granules on SheetMedtrade Products, Ltd. · 2008
- This deviceK113560 Celox Gauze ProMedtrade Products, Ltd. · 2012
- 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 · cites it directly · 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
- Descendant · 2 generations on · 0 of its ownK250319 Mfuse (MS001)Machina Medical, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK253609 TRAUMAGEL® 2.0 Hemostatic GelCresilon, Inc. · 2025
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- 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 · cites it directly2descendants
- K143462AnsCare ChitoClot Gauze (prescription use), AnsCare ChitoClot Gauze (over-the-counter use)Benq Materials Corporation · 2015 · cites it directly2descendants
- K250319Mfuse (MS001)Machina Medical, Inc. · 2025 · 2 generations on0descendants
- K253609TRAUMAGEL® 2.0 Hemostatic GelCresilon, Inc. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K002550 | RDH Bandage | Marine Polymer Technologies, Inc. | 2000 | — |
| −3 | K013390 | Quickclot | On Site Gas Systems, Inc. | 2002 | — |
| −2 | K061079 | Medtrade Products Celox Topical Hemostatic Granules, Medtrade Products Celox… | Medtrade Products, Ltd. | 2006 | — |
| −1 | K080097 | Medtrade Products Celox Hemostatic Granules on Sheet | Medtrade Products, Ltd. | 2008 | — |
| 0 (this device) | K113560 | Celox Gauze Pro | Medtrade Products, Ltd. | 2012 | — |
| +1 | K133121 | Chito-Sam 100,4IN X4IN,Chito-Sam, 3IN X6FT, Chito-Sam 100,3IN X10FT, Chito-Sam… | Sam Medical Products | 2014 | — |
| +1 | K240713 | Traumagel® | Cresilon, Inc. | 2024 | — |
| +1 | K143462 | AnsCare ChitoClot Gauze (prescription use), AnsCare ChitoClot Gauze… | Benq Materials Corporation | 2015 | — |
| +2 | K250319 | Mfuse (MS001) | Machina Medical, Inc. | 2025 | — |
| +2 | K253609 | TRAUMAGEL® 2.0 Hemostatic Gel | Cresilon, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2002 | 2 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2018 | 2 | 0 |
| 2023 | 1 | 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? (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 |
|---|---|---|---|
| * | K080097 | Medtrade Products Celox Hemostatic Granules on SheetSummary page 6…ound, Drug Classification:- Unclassified Legally marketed device(s) for substantial equivalence comparison:- CELOX Hemostatic Granules on Sheet, 510(k) # K080097 and CELOX PRO 510(k) # K093593, manufactured by Medtrade Products Ltd. Device Description:- CELOX Gauze PRO is identical to CEL… | 2008 |
| * | K093593 | Celox Pro, Celox Pro Otc, Celox Hemostatic Granules, Celox Pro Hemostatic Granules, Omni…Summary page 6…Unclassified Legally marketed device(s) for substantial equivalence comparison:- CELOX Hemostatic Granules on Sheet, 510(k) # K080097 and CELOX PRO 510(k) # K093593, manufactured by Medtrade Products Ltd. Device Description:- CELOX Gauze PRO is identical to CELOX Hemostatic Granules on Sheet… | 2010 |
What descends from it? (11)
See all 115 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133121 | Chito-Sam 100,4IN X4IN,Chito-Sam, 3IN X6FT, Chito-Sam 100,3IN X10FT, Chito-Sam Active… | 2014 | 5 |
| K240713 | Traumagel® | 2024 | 2 |
| K143462 | AnsCare ChitoClot Gauze (prescription use), AnsCare ChitoClot Gauze (over-the-counter use) | 2015 | 2 |
| K151204 | HEMO-Bandage | 2015 | 0 |
| K132333 | Bondiloxs Topical Hemostatic Dressing | 2014 | 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 12 years and passes through 3 companies; a new generation was cleared every 4.0 years on median.
- None of the 11 ancestors has a recall.
- Of its descendants, K133121 (Sam Medical Products, 2014) has gone furthest, with 5 descendants of its own.
- 5 other devices also cite its predicate K080097.
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. 2012, 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?
Under the supervision of a healthcare professional CELOX Gauze PRO / CELOX PRO Hemostatic Gauze / OMNI-STAT Gauze / OMNI-STAT Hemostatic Gauze for minor external bleeding from wounds and procedures (Rx) is indicated for use as a temporary topical dressing for bleeding control associated with minor wounds, including control of minor external bleeding and exudate from sutures and/or surgical procedures. Under the supervision of a healthcare professional…
Read the full statement (125 words)
Under the supervision of a healthcare professional CELOX Gauze PRO / CELOX PRO Hemostatic Gauze / OMNI-STAT Gauze / OMNI-STAT Hemostatic Gauze for minor external bleeding from wounds and procedures (Rx) is indicated for use as a temporary topical dressing for bleeding control associated with minor wounds, including control of minor external bleeding and exudate from sutures and/or surgical procedures.
Under the supervision of a healthcare professional CELOX Gauze PRO / CELOX PRO Hemostatic Gauze / OMNI-STAT Gauze / OMNI-STAT Hemostatic Gauze for moderate to severe external bleeding wounds (Rx) is indicated for temporary external treatment for controlling moderate to severe bleeding.
CELOX Gauze PRO (OTC) is indicated for use as a temporary topical dressing for minor cuts, minor abrasions, minor lacerations and minor burns.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113560 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113560: Celox Gauze Pro.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113560
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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