510(k) · Cleared
ClearedStatseal Disc
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biolife, LLC · QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Cleared on Jul 9, 2013 as substantially equivalent to K080210 (Biolife, LLC, 2009) and 1 other predicate after a 151-day review. Its family tree reaches back 3 generations to 2000. 1 later device descends from it.
- Decided
- Jul 9, 2013
- Review
- 151 days
- Class
- Class U
- Product code
- QSY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K002550 (2000). 6 ancestors in all, the oldest K965034 (1998). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK002550 RDH BandageMarine Polymer Technologies, Inc. · 2000
- 2 generations backK013390 QuickclotOn Site Gas Systems, Inc. · 2002
- 1 generation backK080210 Pro QR Advanced Formula PowderBiolife, LLC · 2009
- This deviceK130324 Statseal DiscBiolife, LLC · 2013
- Descendant · cites it directly · 0 of its ownK254073 StatSeal DiscMerit Medical Systems, Inc. · 2026
Most influential descendants
Showing 1 of 1 · See all- K254073StatSeal DiscMerit Medical Systems, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K002550 | RDH Bandage | Marine Polymer Technologies, Inc. | 2000 | — |
| −2 | K013390 | Quickclot | On Site Gas Systems, Inc. | 2002 | — |
| −1 | K080210 | Pro QR Advanced Formula Powder | Biolife, LLC | 2009 | — |
| 0 (this device) | K130324 | Statseal Disc | Biolife, LLC | 2013 | — |
| +1 | K254073 | StatSeal Disc | Merit Medical Systems, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 |
|---|---|---|---|
| * | K080210 | Pro QR Advanced Formula PowderSummary page 6…ressing Classification Name: Dressing, Unclassified 4. Predicate Device Biolife, L.L.C. PRO QR (Quick RelieD®o Powder (K080210) Hemaderm (K021678) Biolife, L.L.C. 8163 2 5"~ Court East, Sarasota, FL 34243 2… | 2009 |
| * | K021678 | Hemaderm Cotaining Hemadex Clotting BeadsSummary page 6…ion Name: Dressing, Unclassified 4. Predicate Device Biolife, L.L.C. PRO QR (Quick RelieD®o Powder (K080210) Hemaderm (K021678) Biolife, L.L.C. 8163 2 5"~ Court East, Sarasota, FL 34243 2… | 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 |
|---|---|---|---|
| K254073 | StatSeal Disc | 2026 | 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 13 years and passes through 3 companies; a new generation was cleared every 4.4 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K254073 (Merit Medical Systems, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K080210.
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. 2013, 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?
Stat'Seal Disc is intended for OTC use as a topical dressing for bleeding control associated with minor wounds, for temporary external control of minor bleeding from minor wounds, minor cuts, minor lacerations and minor burns.
StalSeal Disc is intended under the care of a health care professional for external temporary control of bleeding from percutaneous needle access, vascular access sites and percutaneous catheters.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130324 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130324: Statseal Disc.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130324
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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