510(k) · Cleared
ClearedBloodstop Hemostatic Gauze; IX Hemostatic Gauze
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lifescience Plus, Inc. · QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Cleared on Nov 2, 2007 as substantially equivalent to K010933 (Alltracel Pharma, Ltd., 2002) after a 42-day review. Its family tree reaches back 3 generations to 1995. 6 later devices descend from it.
- Decided
- Nov 2, 2007
- Review
- 42 days
- Class
- Class U
- Product code
- QSY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K953781 (1995). 5 ancestors in all. 6 later devices descend from it, 5 citing it directly.
- Root · 3 generations backK953781 Innovative Technologies Calcium Alginate Wound DressingsInnovative Technologies, Ltd. · 1995
- 2 generations backK980989 3M Tegagen HI Alginate Dressing & 3M Tegagen HG Alginate DressingInnovative Technologies, Ltd. · 1998
- 1 generation backK010933 Seal-on Topical Hempstatic Powder SprayAlltracel Pharma, Ltd. · 2002
- This deviceK072681 Bloodstop Hemostatic Gauze; IX Hemostatic GauzeLifescience Plus, Inc. · 2007
- Descendant · cites it directly · 1 of its ownK093729 Guardiva Antimicrobial Haemostatic IV Dressing, 1 in/ 4MM, Sterile…Hemcon Medical Technologies Europe, Ltd. · 2010
- Descendant · cites it directly · 0 of its ownK160130 BloodSTOP iX Battle MatrixLifescience Plus, Inc. · 2016
- Descendant · 2 generations on · 0 of its ownK121485 Guardiva Antimicrobial Haemstatic IV DressingHemcon Medical Technologies Europe, Ltd. · 2012
- Descendant · cites it directly · 0 of its ownK112800 Suntouch Topical Hemostatic DressingHuizhou Foryou Medical Devices Co., Ltd. · 2012 · Recalled
- Descendant · cites it directly · 0 of its ownK112215 Hemcon Hemostatic GelHemcon Medical Technologies Europe, Ltd. · 2012
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K093729Guardiva Antimicrobial Haemostatic IV Dressing, 1 in/ 4MM, Sterile, Guard Iva…Hemcon Medical Technologies Europe, Ltd. · 2010 · cites it directly1descendant
- K160130BloodSTOP iX Battle MatrixLifescience Plus, Inc. · 2016 · cites it directly0descendants
- K121485Guardiva Antimicrobial Haemstatic IV DressingHemcon Medical Technologies Europe, Ltd. · 2012 · 2 generations on0descendants
- K112800Suntouch Topical Hemostatic DressingHuizhou Foryou Medical Devices Co., Ltd. · 2012 · cites it directly0descendants
- K112215Hemcon Hemostatic GelHemcon Medical Technologies Europe, Ltd. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K953781 | Innovative Technologies Calcium Alginate Wound Dressings | Innovative Technologies, Ltd. | 1995 | — |
| −2 | K980989 | 3M Tegagen HI Alginate Dressing & 3M Tegagen HG Alginate Dressing | Innovative Technologies, Ltd. | 1998 | — |
| −1 | K010933 | Seal-on Topical Hempstatic Powder Spray | Alltracel Pharma, Ltd. | 2002 | — |
| 0 (this device) | K072681 | Bloodstop Hemostatic Gauze; IX Hemostatic Gauze | Lifescience Plus, Inc. | 2007 | — |
| +1 | K093729 | Guardiva Antimicrobial Haemostatic IV Dressing, 1 in/ 4MM, Sterile, Guard Iva… | Hemcon Medical Technologies Europe, Ltd. | 2010 | — |
| +1 | K160130 | BloodSTOP iX Battle Matrix | Lifescience Plus, Inc. | 2016 | — |
| +2 | K121485 | Guardiva Antimicrobial Haemstatic IV Dressing | Hemcon Medical Technologies Europe, Ltd. | 2012 | — |
| +1 | K112800 | Suntouch Topical Hemostatic Dressing | Huizhou Foryou Medical Devices Co., Ltd. | 2012 | 1 |
| +1 | K112215 | Hemcon Hemostatic Gel | Hemcon Medical Technologies Europe, Ltd. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2016 | 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 |
|---|---|---|---|
| * | K010933 | Seal-on Topical Hempstatic Powder SpraySummary page 5…iX Hemostatic Gauze Common Name: Hemostatic wound dressing Product Code: FRO, unclassified 5. Predicate Device: Seal-On Hemostatic Powder Spray, K010933 6. Device Description and Intended Use: BloodSTOP and BloodSTOP iX Hemostatic Gauze are made from regenerated cotton c… | 2002 |
What descends from it? (6)
5 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 12 years and passes through 3 companies; a new generation was cleared every 3.6 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K093729 (Hemcon Medical Technologies Europe, Ltd., 2010) has gone furthest, with 1 descendant of its own.
- 5 other devices also cite its predicate K010933.
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. 2007, 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?
Non-absorbable hemostatic gauze for emergency and therapeutic use in the control of bleeding from the skin and other surface wounds where temporary control of bleeding is required.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072681 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072681: Bloodstop Hemostatic Gauze; IX 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/K072681
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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