510(k) · Cleared
ClearedSeal-on Topical Hempstatic Powder Spray
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alltracel Pharma, Ltd. · QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Cleared on Jan 8, 2002 as substantially equivalent to K980989 (Innovative Technologies, Ltd., 1998) and 2 other predicates after a 286-day review. Its family tree reaches back 2 generations to 1995. 35 later devices descend from it.
- Decided
- Jan 8, 2002
- Review
- 286 days
- Class
- Class U
- Product code
- QSY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K953781 (1995). 4 ancestors in all. 35 later devices descend from it, 6 citing it directly.
- Root · 2 generations backK953781 Innovative Technologies Calcium Alginate Wound DressingsInnovative Technologies, Ltd. · 1995
- 1 generation backK980989 3M Tegagen HI Alginate Dressing & 3M Tegagen HG Alginate DressingInnovative Technologies, Ltd. · 1998
- This deviceK010933 Seal-on Topical Hempstatic Powder SprayAlltracel Pharma, Ltd. · 2002
- Descendant · cites it directly · 23 of its ownK024107 Femostop Femoral Compression SystemRadi Medical Systems AB · 2002
- Descendant · 2 generations on · 17 of its ownK040730 Vascular Solutions D-Stat Clamp Hemostatic ClampVascular Solutions, Inc. · 2004
- Descendant · 3 generations on · 16 of its ownK050146 Vascular Solutions D-Stat Clamp AccessoryVascular Solutions, Inc. · 2005
- Descendant · 2 generations on · 14 of its ownK053300 SyvekexcelMarine Polymer Technologies, Inc. · 2006
- Descendant · 3 generations on · 13 of its ownK061219 D-Stat Dry Hemostatic BandageVascular Solutions, Inc. · 2006
Showing 5 of 35 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 35 · See all- K024107Femostop Femoral Compression SystemRadi Medical Systems AB · 2002 · cites it directly23descendants
- K040730Vascular Solutions D-Stat Clamp Hemostatic ClampVascular Solutions, Inc. · 2004 · 2 generations on17descendants
- K050146Vascular Solutions D-Stat Clamp AccessoryVascular Solutions, Inc. · 2005 · 3 generations on16descendants
- K053300SyvekexcelMarine Polymer Technologies, Inc. · 2006 · 2 generations on14descendants
- K061219D-Stat Dry Hemostatic BandageVascular Solutions, Inc. · 2006 · 3 generations on13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K953781 | Innovative Technologies Calcium Alginate Wound Dressings | Innovative Technologies, Ltd. | 1995 | — |
| −1 | K980989 | 3M Tegagen HI Alginate Dressing & 3M Tegagen HG Alginate Dressing | Innovative Technologies, Ltd. | 1998 | — |
| 0 (this device) | K010933 | Seal-on Topical Hempstatic Powder Spray | Alltracel Pharma, Ltd. | 2002 | — |
| +1 | K024107 | Femostop Femoral Compression System | Radi Medical Systems AB | 2002 | — |
| +2 | K040730 | Vascular Solutions D-Stat Clamp Hemostatic Clamp | Vascular Solutions, Inc. | 2004 | — |
| +3 | K050146 | Vascular Solutions D-Stat Clamp Accessory | Vascular Solutions, Inc. | 2005 | — |
| +2 | K053300 | Syvekexcel | Marine Polymer Technologies, Inc. | 2006 | — |
| +3 | K061219 | D-Stat Dry Hemostatic Bandage | Vascular Solutions, Inc. | 2006 | — |
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 |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 4 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 4 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K980989 | 3M Tegagen HI Alginate Dressing & 3M Tegagen HG Alginate DressingSummary page 5…20504 410154 3. Device Name: Seal-On™ Hemostatic Powder Spray 4. Classification Name: Liquid Bandage (21 CFR 880.5090) 5. Predicate Devices: Tegagen Alginate Dressing (K980989) Dermaphylyx Calcium Alginate Wound Dressing (K991608) Medtrade Products Alginate Island Dressing (K000487) 6. Device Descripti… | 1998 |
| * | K991608 | Dermaphylyx Calcium Alginate Wound DressingSummary page 5…er Spray 4. Classification Name: Liquid Bandage (21 CFR 880.5090) 5. Predicate Devices: Tegagen Alginate Dressing (K980989) Dermaphylyx Calcium Alginate Wound Dressing (K991608) Medtrade Products Alginate Island Dressing (K000487) 6. Device Description and Intended Use: Seal-On™ is a hemostatic powder… | 1999 |
| * | K000487 | Medtrade Products Alginate IslandSummary page 5…R 880.5090) 5. Predicate Devices: Tegagen Alginate Dressing (K980989) Dermaphylyx Calcium Alginate Wound Dressing (K991608) Medtrade Products Alginate Island Dressing (K000487) 6. Device Description and Intended Use: Seal-On™ is a hemostatic powder spray containing Microdispersed Oxidized Cellulose in… | 2000 |
What descends from it? (35)
See all 356 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K024107 | Femostop Femoral Compression System | 2002 | 23 |
| K072681 | Bloodstop Hemostatic Gauze; IX Hemostatic Gauze | 2007 | 6 |
| K071578 | Bloodstop and Bloodstop IX Hemostatic Gauze, Models BS-10,BS-11,BS-12,B-13, BS-IX27… | 2007 | 3 |
| K093729 | Guardiva Antimicrobial Haemostatic IV Dressing, 1 in/ 4MM, Sterile, Guard Iva… | 2010 | 1 |
| K210751 | S.E.A.L. Hemostatic Wound Spray | 2023 | 0 |
| K112215 | Hemcon Hemostatic Gel | 2012 | 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 7 years and passes through 2 companies; a new generation was cleared every 3.6 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K024107 (Radi Medical Systems AB, 2002) has gone furthest, with 23 descendants of its own.
- 1 other device also cites its predicate K980989.
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.
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?
Seal-On™ Topical Hemostatic Spray is intended to be used for topical control of bleeding from minor cuts and abrasions of the skin surface.
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/K010933 · printed Nov 6, 2026
Cite this page
510(k) Report. “K010933: Seal-on Topical Hempstatic Powder Spray.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010933
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026