510(k) · Cleared
ClearedPrometheus ChitoGauze XR PRO
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hem Con Medical Technologies, Inc. · QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Cleared on May 25, 2016 as substantially equivalent to K090026 (Hem Con Medical Technologies, Inc., 2009) and 2 other predicates after a 162-day review. Its family tree reaches back 9 generations to 2000. 2 later devices descend from it.
- Decided
- May 25, 2016
- Review
- 162 days
- Class
- Class U
- Product code
- QSY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K002550 (2000). 18 ancestors in all, the oldest K821150 (1982). 2 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK002550 RDH BandageMarine Polymer Technologies, Inc. · 2000
- 5 generations between
- 3 generations backK090026 Chitogauze, Models 130, 131, 263, 264, 265, 266Hem Con Medical Technologies, Inc. · 2009
- 2 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
- 1 generation backK102546 ChitogauzeHem Con Medical Technologies, Inc. · 2010
- This deviceK153582 Prometheus ChitoGauze XR PROHem Con Medical Technologies, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK230589 Celox Rapid X-Ray GauzeMedtrade Products, Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK192671 Hemostatic Xerogel SpongeSolaplus Biotech Co., Ltd. · 2020
Show all 9 generations
- Root · 9 generations backK002550 RDH BandageMarine Polymer Technologies, Inc. · 2000
- 8 generations backK013390 QuickclotOn Site Gas Systems, Inc. · 2002
- 7 generations backK051955 Quickclot Acs - Accelerated Clotting SpongeZ-Medica Corporation · 2005
- 6 generations backK061767 Quikclot 1ST Response & Quikclot Acs+Z-Medica Corporation · 2006
- 5 generations backK070010 Quikclot Sport and Quikclot Sport SilverZ-Medica Corporation · 2007
- 4 generations backK072474 Quikclot EXZ-Medica Corporation · 2007 · Recalled
- 3 generations backK090026 Chitogauze, Models 130, 131, 263, 264, 265, 266Hem Con Medical Technologies, Inc. · 2009
- 2 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
- 1 generation backK102546 ChitogauzeHem Con Medical Technologies, Inc. · 2010
- This deviceK153582 Prometheus ChitoGauze XR PROHem Con Medical Technologies, Inc. · 2016
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K002550 | RDH Bandage | Marine Polymer Technologies, Inc. | 2000 | — |
| −8 | K013390 | Quickclot | On Site Gas Systems, Inc. | 2002 | — |
| −7 | K051955 | Quickclot Acs - Accelerated Clotting Sponge | Z-Medica Corporation | 2005 | — |
| −6 | K061767 | Quikclot 1ST Response & Quikclot Acs+ | Z-Medica Corporation | 2006 | — |
| −5 | K070010 | Quikclot Sport and Quikclot Sport Silver | Z-Medica Corporation | 2007 | — |
| −4 | K072474 | Quikclot EX | Z-Medica Corporation | 2007 | 1 |
| −3 | K090026 | Chitogauze, Models 130, 131, 263, 264, 265, 266 | Hem Con Medical Technologies, Inc. | 2009 | — |
| −2 | 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 | — |
| −1 | K102546 | Chitogauze | Hem Con Medical Technologies, Inc. | 2010 | — |
| 0 (this device) | K153582 | Prometheus ChitoGauze XR PRO | Hem Con Medical Technologies, Inc. | 2016 | — |
| +1 | K230589 | Celox Rapid X-Ray Gauze | Medtrade Products, Ltd. | 2023 | — |
| +1 | K192671 | Hemostatic Xerogel Sponge | Solaplus Biotech Co., Ltd. | 2020 | — |
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 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 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? (3)
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 |
|---|---|---|---|
| * | K090026 | Chitogauze, Models 130, 131, 263, 264, 265, 266Summary page 5…ed Classification Panel: 878 – General and Plastic Surgery III. Predicate Device(s): Predicate Device: HemCon® ChitoGauze® (K090026, K092357) / ChitoGauze® XR (K102546) Reference Device: HemCon G… | 2009 |
| * | 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 in, 8PLY…Summary page 5…fication Panel: 878 – General and Plastic Surgery III. Predicate Device(s): Predicate Device: HemCon® ChitoGauze® (K090026, K092357) / ChitoGauze® XR (K102546) Reference Device: HemCon GuardaCare… | 2009 |
| * | K102546 | ChitogauzeSummary page 5…III. Predicate Device(s): Predicate Device: HemCon® ChitoGauze® (K090026, K092357) / ChitoGauze® XR (K102546) Reference Device: HemCon GuardaCareTMXR (K103641) The predicate device has not been subject to a design… | 2010 |
| † | K103641 | Guardacare | 2011 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 16 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 2 of the 18 ancestors have a recall of any class.
- Of its descendants, K230589 (Medtrade Products, Ltd., 2023) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K090026.
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. 2016, 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?
Prometheus ChitoGauze® XR PRO is a hemostatic dressing for the external, temporary control of severely bleeding wounds
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153582 · printed Nov 5, 2026
Cite this page
510(k) Report. “K153582: Prometheus ChitoGauze XR PRO.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K153582
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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