510(k) · Cleared
ClearedCelox Rapid X-Ray 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 Nov 17, 2023 as substantially equivalent to K110386 (Medtrade Products, Ltd., 2011) and 1 other predicate after a 260-day review. Its family tree reaches back 10 generations to 2000.
- Decided
- Nov 17, 2023
- Review
- 260 days
- Class
- Class U
- Product code
- QSY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K002550 (2000). 22 ancestors in all, the oldest K821150 (1982). No later device cites it as a predicate yet.
- Root · 10 generations backK002550 RDH BandageMarine Polymer Technologies, Inc. · 2000
- 6 generations between
- 3 generations backK092357 Chitogauze,2 in X 2 in,8 Ply, 4 in X 4 in 8 Ply, 4 in X 8 in, 8PLY…Hem Con Medical Technologies, Inc. · 2009
- 2 generations backK102546 ChitogauzeHem Con Medical Technologies, Inc. · 2010
- 1 generation backK153582 Prometheus ChitoGauze XR PROHem Con Medical Technologies, Inc. · 2016
- This deviceK230589 Celox Rapid X-Ray GauzeMedtrade Products, Ltd. · 2023
Show all 10 generations
- Root · 10 generations backK002550 RDH BandageMarine Polymer Technologies, Inc. · 2000
- 9 generations backK013390 QuickclotOn Site Gas Systems, Inc. · 2002
- 8 generations backK051955 Quickclot Acs - Accelerated Clotting SpongeZ-Medica Corporation · 2005
- 7 generations backK061767 Quikclot 1ST Response & Quikclot Acs+Z-Medica Corporation · 2006
- 6 generations backK070010 Quikclot Sport and Quikclot Sport SilverZ-Medica Corporation · 2007
- 5 generations backK072474 Quikclot EXZ-Medica Corporation · 2007 · Recalled
- 4 generations backK090026 Chitogauze, Models 130, 131, 263, 264, 265, 266Hem Con Medical Technologies, Inc. · 2009
- 3 generations backK092357 Chitogauze,2 in X 2 in,8 Ply, 4 in X 4 in 8 Ply, 4 in X 8 in, 8PLY…Hem Con Medical Technologies, Inc. · 2009
- 2 generations backK102546 ChitogauzeHem Con Medical Technologies, Inc. · 2010
- 1 generation backK153582 Prometheus ChitoGauze XR PROHem Con Medical Technologies, Inc. · 2016
- This deviceK230589 Celox Rapid X-Ray GauzeMedtrade Products, Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K002550 | RDH Bandage | Marine Polymer Technologies, Inc. | 2000 | — |
| −9 | K013390 | Quickclot | On Site Gas Systems, Inc. | 2002 | — |
| −8 | K051955 | Quickclot Acs - Accelerated Clotting Sponge | Z-Medica Corporation | 2005 | — |
| −7 | K061767 | Quikclot 1ST Response & Quikclot Acs+ | Z-Medica Corporation | 2006 | — |
| −6 | K070010 | Quikclot Sport and Quikclot Sport Silver | Z-Medica Corporation | 2007 | — |
| −5 | K072474 | Quikclot EX | Z-Medica Corporation | 2007 | 1 |
| −4 | K090026 | Chitogauze, Models 130, 131, 263, 264, 265, 266 | Hem Con Medical Technologies, Inc. | 2009 | — |
| −3 | K092357 | Chitogauze,2 in X 2 in,8 Ply, 4 in X 4 in 8 Ply, 4 in X 8 in, 8PLY, 1 in X 4… | Hem Con Medical Technologies, Inc. | 2009 | — |
| −2 | K102546 | Chitogauze | Hem Con Medical Technologies, Inc. | 2010 | — |
| −1 | K153582 | Prometheus ChitoGauze XR PRO | Hem Con Medical Technologies, Inc. | 2016 | — |
| 0 (this device) | K230589 | Celox Rapid X-Ray Gauze | Medtrade Products, Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
| 2011 | 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 |
|---|---|---|---|
| * | K110386 | Celox Rapid GauzeSummary page 5…/ Reference Device/s: Predicate 1 Device Primary Predicate Device Name: CELOX Rapid Gauze Company: Medtrade Products Ltd 510(k) Number: K110386 Product Code: QSY Predicate 2 Device Secondary Predicate Device Name: Prometheus ChitoGauze XR Pro Company:… | 2011 |
| * | K153582 | Prometheus ChitoGauze XR PROSummary page 5…SY Predicate 2 Device Secondary Predicate Device Name: Prometheus ChitoGauze XR Pro Company: HemCon Medical Technologies 510(k) Number: K153582 Product Code: QSY Reference 1 Device Reference Device Device Name: Celox Hemostatic Granules on Sheet Compa… | 2016 |
| † | K080097 | Medtrade Products Celox Hemostatic Granules on Sheet | 2008 |
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 23 years and passes through 5 companies; a new generation was cleared every 1.4 years on median.
- 2 of the 22 ancestors have a recall of any class.
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. 2023, 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 X-Ray detectable Z-fold hemostatic Gauze is indicated for temporary external use to control moderate to severe bleeding. May also be indicate 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/K230589 · printed Nov 4, 2026
Cite this page
510(k) Report. “K230589: Celox Rapid X-Ray Gauze.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K230589
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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