510(k) · Cleared
ClearedS.E.A.L. Hemostatic Wound Spray
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bc3 Technologies, Inc. · QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Cleared on Feb 2, 2023 as substantially equivalent to K061079 (Medtrade Products, Ltd., 2006) and 1 other predicate after a 692-day review. Its family tree reaches back 3 generations to 1995.
- Decided
- Feb 2, 2023
- Review
- 692 days
- Class
- Class U
- Product code
- QSY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K953781 (1995). 10 ancestors in all. No later device cites it as a predicate yet.
- 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 deviceK210751 S.E.A.L. Hemostatic Wound SprayBc3 Technologies, Inc. · 2023
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) | K210751 | S.E.A.L. Hemostatic Wound Spray | Bc3 Technologies, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 2 | 0 |
| 2006 | 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 |
|---|---|---|---|
| * | K061079 | Medtrade Products Celox Topical Hemostatic Granules, Medtrade Products Celox 762…Summary page 4…sification Name: Unclassified – Device, Dressing Regulatory Class: NA Product Code: FRO III. PREDICATE DEVICE Primary Predicate: CELOX Topical Hemostatic Granules (K061079) Manufactured by MedTrade Products Supporting Predicate: Seal-On™ Hemostatic Powder Spray (K010933) The predicate devices have… | 2006 |
| * | K010933 | Seal-on Topical Hempstatic Powder SpraySummary page 4…EDICATE DEVICE Primary Predicate: CELOX Topical Hemostatic Granules (K061079) Manufactured by MedTrade Products Supporting Predicate: Seal-On™ Hemostatic Powder Spray (K010933) The predicate devices have not been subject to a design-related recall. IV. DESCRIPTION S.E.A.L. Hemostatic Wound S… | 2002 |
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 28 years and passes through 3 companies; a new generation was cleared every 3.6 years on median.
- None of the 10 ancestors has a recall.
- 6 other devices also cite its predicate K061079.
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. 2023, 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?
S.E.A.L. Hemostatic Wound Spray is intended to be used to achieve hemostasis in emergency situations for the temporary control of severe topical bleeding.
S.E.A.L. Hemostatic Wound Spray is indicated for the local management of minor bleeding such as minor lacerations, minor cuts and minor abrasions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210751 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210751: S.E.A.L. Hemostatic Wound Spray.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210751
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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