510(k) · Cleared
ClearedHemostatic Xerogel Sponge
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Solaplus Biotech Co., Ltd. · QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Cleared on Aug 28, 2020 as substantially equivalent to K153582 (Hem Con Medical Technologies, Inc., 2016) after a 337-day review. Its family tree reaches back 10 generations to 2000.
- Decided
- Aug 28, 2020
- Review
- 337 days
- Class
- Class U
- Product code
- QSY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K002550 (2000). 19 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 deviceK192671 Hemostatic Xerogel SpongeSolaplus Biotech Co., Ltd. · 2020
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 deviceK192671 Hemostatic Xerogel SpongeSolaplus Biotech Co., Ltd. · 2020
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) | 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 |
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 |
|---|---|---|---|
| * | K153582 | Prometheus ChitoGauze XR PROSummary page 6…enance package which could maintain the sterility of the device during the shelf life of 2 years. 5. Identification of Predicate Device Predicate Device 510(k) Number: K153582 Product Name: Prometheus ChitoGauze® XR PRO Manufacturer: HemCon Medical Technologies, Inc. 6. Non-Clinical Test Conclusion N… | 2016 |
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 20 years and passes through 5 companies; a new generation was cleared every 1.4 years on median.
- 2 of the 19 ancestors have a recall of any class.
- 1 other device also cites its predicate K153582.
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. 2020, 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?
The Hemostatic Xerogel Sponge is a hemostatic dressing for the external, temporary control of severely bleeding wounds.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K192671 · printed Nov 5, 2026
Cite this page
510(k) Report. “K192671: Hemostatic Xerogel Sponge.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K192671
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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