510(k) · Cleared
Recalled · Class II · 2015Suntouch Topical Hemostatic Dressing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Huizhou Foryou Medical Devices Co., Ltd. · QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Cleared on May 23, 2012 as substantially equivalent to K072681 (Lifescience Plus, Inc., 2007) and 1 other predicate after a 239-day review. Its family tree reaches back 4 generations to 1995. It has been recalled once.
- Decided
- May 23, 2012
- Review
- 239 days
- Class
- Class U
- Product code
- QSY
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 4 generations to K953781 (1995). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK953781 Innovative Technologies Calcium Alginate Wound DressingsInnovative Technologies, Ltd. · 1995
- 3 generations backK980989 3M Tegagen HI Alginate Dressing & 3M Tegagen HG Alginate DressingInnovative Technologies, Ltd. · 1998
- 2 generations backK010933 Seal-on Topical Hempstatic Powder SprayAlltracel Pharma, Ltd. · 2002
- 1 generation backK071578 Bloodstop and Bloodstop IX Hemostatic Gauze, Models…Lifescience Plus, Inc. · 2007
- This deviceK112800 Suntouch Topical Hemostatic DressingHuizhou Foryou Medical Devices Co., Ltd. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K953781 | Innovative Technologies Calcium Alginate Wound Dressings | Innovative Technologies, Ltd. | 1995 | — |
| −3 | K980989 | 3M Tegagen HI Alginate Dressing & 3M Tegagen HG Alginate Dressing | Innovative Technologies, Ltd. | 1998 | — |
| −2 | K010933 | Seal-on Topical Hempstatic Powder Spray | Alltracel Pharma, Ltd. | 2002 | — |
| −1 | K071578 | Bloodstop and Bloodstop IX Hemostatic Gauze, Models BS-10,BS-11,BS-12,B-13… | Lifescience Plus, Inc. | 2007 | — |
| 0 (this device) | K112800 | Suntouch Topical Hemostatic Dressing | Huizhou Foryou Medical Devices Co., Ltd. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2007 | 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 |
|---|---|---|---|
| * | K072681 | Bloodstop Hemostatic Gauze; IX Hemostatic GauzeSummary page 6…untouch Topical Hemostatic Dressing is compared with the following Predicate Devices in terms of intended use, design, material, specifications, and performance. (1) K07268 1, "Bloodstop Hemostatic Gauze; Ix Hemostatic Gauze", manufactured by "Lifescience Plus, Inc" located in Mystic, CT 06355… | 2007 |
| * | K071578 | Bloodstop and Bloodstop IX Hemostatic Gauze, Models BS-10,BS-11,BS-12,B-13, BS-IX27…Summary page 6…, and performance. (1) K07268 1, "Bloodstop Hemostatic Gauze; Ix Hemostatic Gauze", manufactured by "Lifescience Plus, Inc" located in Mystic, CT 06355 (2) K071578, " Bloodstop And Bloodstop IX Hemostatic Gauze", manufactured by "Lifescience Plus, Inc" located in Mystic, CT 06355 S… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 18, 2015 | Class II | Z-1697-2015 | Labeling False and Misleading | Coreva Health Science, LLC. is recalling ActCel Hemostatic Dressing due to customer literature and web sites promoting that it can help control bleeding from open wounds and in body cavities. ActCel is indicated as a prescription device… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 4 companies; a new generation was cleared every 4.7 years on median.
- None of the 7 ancestors has a recall.
- 4 other devices also cite its predicate K072681.
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. 2012, 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:
Suntouch Topical Hemostatic Dressing is indicated for the management of topical
wounds and to temporary control of external surface bleeding;
All gauze are sterilized and sold directly to users after sterilization by radiation using
conditions validated following ISO 11137-2: 2006.
Over the Counter:
Suntouch Topical Hemostatic Dressing is indicated for temporary external topical
bleeding of minor cuts, minor lacerations, and it is contraindicated for internal use.
All gauze are sterilized and sold directly to users after sterilization by radiation using
conditions validated following ISO 11137-2: 2006.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112800 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112800: Suntouch Topical Hemostatic Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112800
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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