510(k) · Cleared
ClearedCelox Rapid Gauze
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 May 10, 2011 as substantially equivalent to K080097 (Medtrade Products, Ltd., 2008) after an 89-day review. Its family tree reaches back 4 generations to 2000. 1 later device descends from it.
- Decided
- May 10, 2011
- Review
- 89 days
- Class
- Class U
- Product code
- QSY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K002550 (2000). 6 ancestors in all, the oldest K972914 (1997). 1 later device descends from it, 1 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 deviceK110386 Celox Rapid GauzeMedtrade Products, Ltd. · 2011
- Descendant · cites it directly · 0 of its ownK230589 Celox Rapid X-Ray GauzeMedtrade Products, Ltd. · 2023
Most influential descendants
Showing 1 of 1 · See all- K230589Celox Rapid X-Ray GauzeMedtrade Products, Ltd. · 2023 · cites it directly0descendants
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) | K110386 | Celox Rapid Gauze | Medtrade Products, Ltd. | 2011 | — |
| +1 | K230589 | Celox Rapid X-Ray Gauze | Medtrade Products, Ltd. | 2023 | — |
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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K080097 | Medtrade Products Celox Hemostatic Granules on SheetSummary page 6…Classification Name: Dressing, Unclassified 5.4 Predicate Device Medtrade Products Limited: CELOX Hemostatic Granules on Sheet (K080097) 5.5 Device Description Components - CELOX Rapid iscomposed of chitosan Mechan… | 2008 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K230589 | Celox Rapid X-Ray Gauze | 2023 | 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 11 years and passes through 3 companies; a new generation was cleared every 2.8 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K230589 (Medtrade Products, Ltd., 2023) has gone furthest, with 0 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. 2011, 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?
CELOX Rapid Gauze is indicated for temporary external use to control moderate to severe
bleeding.
CELOX Rapid Gauze 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/K110386 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110386: Celox Rapid Gauze.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110386
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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