510(k) · Cleared
ClearedMedtrade Products Celox Solbag, Anti - Coagulant
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 Dec 21, 2007 as substantially equivalent to K061079 (Medtrade Products, Ltd., 2006) and 1 other predicate after a 123-day review. Its family tree reaches back 3 generations to 2000.
- Decided
- Dec 21, 2007
- Review
- 123 days
- Class
- Class U
- Product code
- QSY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K002550 (2000). 6 ancestors in all, the oldest K972914 (1997). No later device cites it as a predicate yet.
- Root · 3 generations backK002550 RDH BandageMarine Polymer Technologies, Inc. · 2000
- 2 generations backK013390 QuickclotOn Site Gas Systems, Inc. · 2002
- 1 generation backK051955 Quickclot Acs - Accelerated Clotting SpongeZ-Medica Corporation · 2005
- This deviceK072328 Medtrade Products Celox Solbag, Anti - CoagulantMedtrade Products, Ltd. · 2007
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 | K051955 | Quickclot Acs - Accelerated Clotting Sponge | Z-Medica Corporation | 2005 | — |
| 0 (this device) | K072328 | Medtrade Products Celox Solbag, Anti - Coagulant | Medtrade Products, Ltd. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2002 | 1 | 0 |
| 2006 | 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? (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 |
|---|---|---|---|
| * | K061079 | Medtrade Products Celox Topical Hemostatic Granules, Medtrade Products Celox 762…Summary page 6…s CELOX Topical Hemostatic Granules in Soluble Bag are essentially the same product. In that the CELOX Topical Hemostatic Granules are exactly as in our 510(k) K061079 and the Soluble Beg prevents any accidental spillage of the granules whilst opening the sachet and provides a controlled and… | 2006 |
| * | K051955 | Quickclot Acs - Accelerated Clotting SpongeSummary page 6…rade Products CELOX Topical Hemostatic Granules K061079 and substantially equivalent in physical state and application via bag to Z-Medica Corporation QuikCiot ACS K051955. A table of comparative features may be found below COMPARA TIVE FEATURES… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
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 7 years and passes through 4 companies; a new generation was cleared every 2.4 years on median.
- None of the 6 ancestors has a recall.
- 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. 2007, 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 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 are intended to be available Over The Counter for the following indication.
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 summary.
https://510kreport.com/device/K072328 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072328: Medtrade Products Celox Solbag, Anti - Coagulant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072328
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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