510(k) · Cleared
ClearedZeolite Hemostatic Gauze
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hangzhou Zeo-Innov Life Technology Co., Ltd. · QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Cleared on Feb 10, 2022 as substantially equivalent to K072474 (Z-Medica Corporation, 2007) after a 265-day review. Its family tree reaches back 6 generations to 2000. 1 later device descends from it.
- Decided
- Feb 10, 2022
- Review
- 265 days
- Class
- Class U
- Product code
- QSY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K002550 (2000). 9 ancestors in all, the oldest K821150 (1982). 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK002550 RDH BandageMarine Polymer Technologies, Inc. · 2000
- 5 generations backK013390 QuickclotOn Site Gas Systems, Inc. · 2002
- 4 generations backK051955 Quickclot Acs - Accelerated Clotting SpongeZ-Medica Corporation · 2005
- 3 generations backK061767 Quikclot 1ST Response & Quikclot Acs+Z-Medica Corporation · 2006
- 2 generations backK070010 Quikclot Sport and Quikclot Sport SilverZ-Medica Corporation · 2007
- 1 generation backK072474 Quikclot EXZ-Medica Corporation · 2007 · Recalled
- This deviceK211570 Zeolite Hemostatic GauzeHangzhou Zeo-Innov Life Technology Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK223495 Zeolite Hemostatic CottonHangzhou Zeo-Innov Life Technology Co., Ltd. · 2023
Most influential descendants
Showing 1 of 1 · See all- K223495Zeolite Hemostatic CottonHangzhou Zeo-Innov Life Technology Co., Ltd. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K002550 | RDH Bandage | Marine Polymer Technologies, Inc. | 2000 | — |
| −5 | K013390 | Quickclot | On Site Gas Systems, Inc. | 2002 | — |
| −4 | K051955 | Quickclot Acs - Accelerated Clotting Sponge | Z-Medica Corporation | 2005 | — |
| −3 | K061767 | Quikclot 1ST Response & Quikclot Acs+ | Z-Medica Corporation | 2006 | — |
| −2 | K070010 | Quikclot Sport and Quikclot Sport Silver | Z-Medica Corporation | 2007 | — |
| −1 | K072474 | Quikclot EX | Z-Medica Corporation | 2007 | 1 |
| 0 (this device) | K211570 | Zeolite Hemostatic Gauze | Hangzhou Zeo-Innov Life Technology Co., Ltd. | 2022 | — |
| +1 | K223495 | Zeolite Hemostatic Cotton | Hangzhou Zeo-Innov Life Technology Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1998 | 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 |
|---|---|---|---|
| * | K072474 | Quikclot EXSummary page 6…Each type is available in a range of different sizes. 5. Identification of Predicate Device and Reference Device Predicate device: 510(k) number: K072474 Product Name: QuikClot® eXTM Reference device: 510(k) number: K013390 Product Name: QuikClot 6.… | 2007 |
| † | K013390 | Quickclot | 2002 |
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 |
|---|---|---|---|
| K223495 | Zeolite Hemostatic Cotton | 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 22 years and passes through 4 companies; a new generation was cleared every 1.4 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K223495 (Hangzhou Zeo-Innov Life Technology Co., Ltd., 2023) has gone furthest, with 0 descendants of its own.
- 7 other devices also cite its predicate K072474.
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. 2022, 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?
Prescription Use: Zeolite Hemostatic Gauze is intended for temporary external use to control traumatic bleeding.
Over-The-Counter Use: Zeolite Hemostatic Gauze is intended for temporary external use to stop bleeding of superficial wounds, minor cuts, and abrasions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211570 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211570: Zeolite Hemostatic Gauze.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211570
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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