510(k) · Cleared
ClearedMedtrade Products Celox Topical Hemostatic Granules, Medtrade Products Celox 762 Hemostatic Granules
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 Jun 2, 2006 as substantially equivalent to K023298 (Hemcon, Inc., 2002) and 1 other predicate after a 46-day review. Its family tree reaches back 2 generations to 2000. 27 later devices descend from it.
- Decided
- Jun 2, 2006
- Review
- 46 days
- Class
- Class U
- Product code
- QSY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K002550 (2000). 4 ancestors in all, the oldest K972914 (1997). 27 later devices descend from it, 7 citing it directly.
- Root · 2 generations backK002550 RDH BandageMarine Polymer Technologies, Inc. · 2000
- 1 generation backK013390 QuickclotOn Site Gas Systems, Inc. · 2002
- This deviceK061079 Medtrade Products Celox Topical Hemostatic Granules, Medtrade…Medtrade Products, Ltd. · 2006
- Descendant · cites it directly · 18 of its ownK080097 Medtrade Products Celox Hemostatic Granules on SheetMedtrade Products, Ltd. · 2008
- Descendant · cites it directly · 13 of its ownK093593 Celox Pro, Celox Pro Otc, Celox Hemostatic Granules, Celox Pro…Medtrade Products Limited · 2010
- Descendant · 2 generations on · 11 of its ownK113560 Celox Gauze ProMedtrade Products, Ltd. · 2012
- Descendant · 2 generations on · 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
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 27 · See all- K080097Medtrade Products Celox Hemostatic Granules on SheetMedtrade Products, Ltd. · 2008 · cites it directly18descendants
- K093593Celox Pro, Celox Pro Otc, Celox Hemostatic Granules, Celox Pro Hemostatic Granules, Omni…Medtrade Products Limited · 2010 · cites it directly13descendants
- K113560Celox Gauze ProMedtrade Products, Ltd. · 2012 · 2 generations on11descendants
- K091795Medtrade Products Celox Trauma GauzeMedtrade Products, Ltd. · 2009 · 2 generations on7descendants
- K133121Chito-Sam 100,4IN X4IN,Chito-Sam, 3IN X6FT, Chito-Sam 100,3IN X10FT, Chito-Sam Active…Sam Medical Products · 2014 · 2 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K002550 | RDH Bandage | Marine Polymer Technologies, Inc. | 2000 | — |
| −1 | K013390 | Quickclot | On Site Gas Systems, Inc. | 2002 | — |
| 0 (this device) | 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 | — |
| +1 | K093593 | Celox Pro, Celox Pro Otc, Celox Hemostatic Granules, Celox Pro Hemostatic… | Medtrade Products Limited | 2010 | — |
| +2 | K113560 | Celox Gauze Pro | Medtrade Products, Ltd. | 2012 | — |
| +2 | 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 | — |
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 |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2023 | 4 | 0 |
| 2024 | 3 | 0 |
| 2025 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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 |
|---|---|---|---|
| * | K023298 | Hemcon BandageSummary page 7…SgKys to 3SkGys. Med[Trade CELOX Topical Hemostatic Granules is substantially equivalent in chemistry and technology HemCon Incorporated, HemrCon Bandage K023298 and in physical state and application to: On Site to:… | 2002 |
| * | K013390 | QuickclotSummary page 7…tion to: On Site to: Gas Systems / Z-Medica's, QuickClot K01 3390 COMPARATIVE PEA TURES Caracteristics MedTrade… | 2002 |
What descends from it? (27)
See all 277 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K080097 | Medtrade Products Celox Hemostatic Granules on Sheet | 2008 | 18 |
| K093593 | Celox Pro, Celox Pro Otc, Celox Hemostatic Granules, Celox Pro Hemostatic Granules, Omni… | 2010 | 13 |
| K220525 | RESPONDER Polysaccharide Hemostat | 2023 | 1 |
| K210751 | S.E.A.L. Hemostatic Wound Spray | 2023 | 0 |
| K090780 | Medtrade Products Celox Topical Hemostatic Paste | 2009 | 0 |
| K082601 | UltraClot, UltraClot OTC | 2008 | 0 |
| K072328 | Medtrade Products Celox Solbag, Anti - Coagulant | 2007 | 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 6 years and passes through 3 companies; a new generation was cleared every 4.0 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K080097 (Medtrade Products, Ltd., 2008) has gone furthest, with 18 descendants of its own.
- 4 other devices also cite its predicate K023298.
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.
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 Topical Hemostatic Granules are intended to be used
to achieve hemostasis in emergency situations for the temporary control of severe
topical bleeding.
MedTrade Products CELOX Topical Hemostatic Granules OTC are indicated for the
local management of bleeding such as lacerations, minor cuts and abrasions.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K061079 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061079: Medtrade Products Celox Topical Hemostatic Granules, Medtrade Products Celox 762 Hemostatic Granules.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061079
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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