510(k) · Cleared
ClearedStasilon FR
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Entegrion, Inc. · QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Cleared on Dec 10, 2007 as substantially equivalent to K043050 (Hemcon, Inc., 2005) and 3 other predicates after a 61-day review. Its family tree reaches back 8 generations to 1995. 5 later devices descend from it.
- Decided
- Dec 10, 2007
- Review
- 61 days
- Class
- Class U
- Product code
- QSY
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 8 generations to K953781 (1995). 34 ancestors in all, the oldest K896068 (1990). 5 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK953781 Innovative Technologies Calcium Alginate Wound DressingsInnovative Technologies, Ltd. · 1995
- 7 generations backK980989 3M Tegagen HI Alginate Dressing & 3M Tegagen HG Alginate DressingInnovative Technologies, Ltd. · 1998
- 6 generations backK010933 Seal-on Topical Hempstatic Powder SprayAlltracel Pharma, Ltd. · 2002
- 5 generations backK024107 Femostop Femoral Compression SystemRadi Medical Systems AB · 2002
- 4 generations backK040730 Vascular Solutions D-Stat Clamp Hemostatic ClampVascular Solutions, Inc. · 2004
- 3 generations backK050146 Vascular Solutions D-Stat Clamp AccessoryVascular Solutions, Inc. · 2005
- 2 generations backK053300 SyvekexcelMarine Polymer Technologies, Inc. · 2006
- 1 generation backK061219 D-Stat Dry Hemostatic BandageVascular Solutions, Inc. · 2006
- This deviceK072890 Stasilon FREntegrion, Inc. · 2007
- Descendant · cites it directly · 4 of its ownK142363 Nustat, Nustat XRBeeken Biomedical · 2015
- Descendant · 2 generations on · 2 of its ownK222189 SiOxD Wound MatrixSioxmed, LLC · 2022
- Descendant · 3 generations on · 1 of its ownK232847 SiOxD Wound MatrixSioxmed, LLC · 2023
- Descendant · 3 generations on · 0 of its ownK241660 SiOxD® Wound MatrixSioxmed, LLC · 2024
- Descendant · 2 generations on · 0 of its ownK160578 Nustat XRBeeken Biomedical, LLC · 2016
Most influential descendants
Showing 5 of 5 · See all- K142363Nustat, Nustat XRBeeken Biomedical · 2015 · cites it directly4descendants
- K222189SiOxD Wound MatrixSioxmed, LLC · 2022 · 2 generations on2descendants
- K232847SiOxD Wound MatrixSioxmed, LLC · 2023 · 3 generations on1descendant
- K241660SiOxD® Wound MatrixSioxmed, LLC · 2024 · 3 generations on0descendants
- K160578Nustat XRBeeken Biomedical, LLC · 2016 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K953781 | Innovative Technologies Calcium Alginate Wound Dressings | Innovative Technologies, Ltd. | 1995 | — |
| −7 | K980989 | 3M Tegagen HI Alginate Dressing & 3M Tegagen HG Alginate Dressing | Innovative Technologies, Ltd. | 1998 | — |
| −6 | K010933 | Seal-on Topical Hempstatic Powder Spray | Alltracel Pharma, Ltd. | 2002 | — |
| −5 | K024107 | Femostop Femoral Compression System | Radi Medical Systems AB | 2002 | — |
| −4 | 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 | — |
| −1 | K061219 | D-Stat Dry Hemostatic Bandage | Vascular Solutions, Inc. | 2006 | — |
| 0 (this device) | K072890 | Stasilon FR | Entegrion, Inc. | 2007 | — |
| +1 | K142363 | Nustat, Nustat XR | Beeken Biomedical | 2015 | — |
| +2 | K222189 | SiOxD Wound Matrix | Sioxmed, LLC | 2022 | — |
| +3 | K232847 | SiOxD Wound Matrix | Sioxmed, LLC | 2023 | — |
| +3 | K241660 | SiOxD® Wound Matrix | Sioxmed, LLC | 2024 | — |
| +2 | K160578 | Nustat XR | Beeken Biomedical, LLC | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 4 | 0 |
| 1998 | 4 | 0 |
| 1999 | 2 | 0 |
| 2000 | 3 | 0 |
| 2002 | 4 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 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 15.1 · 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? (4)
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 |
|---|---|---|---|
| * | K043050 | Hemcon Bandage and Hemcon Bandage OtcSummary page 6…t Code: FRO Device Class: Unclassified Predicate Device Trade Name (510(k) Number) Product Code HemCon Bandage and HemCon OTC (K043050) FRO QuikClot ACS (K051955) FRO D-Stat Dry Hemostatic Bandage (K061219… | 2005 |
| * | K051955 | Quickclot Acs - Accelerated Clotting SpongeSummary page 6…Unclassified Predicate Device Trade Name (510(k) Number) Product Code HemCon Bandage and HemCon OTC (K043050) FRO QuikClot ACS (K051955) FRO D-Stat Dry Hemostatic Bandage (K061219) FRO, DXC Syvekexcel (K053… | 2005 |
| * | K061219 | D-Stat Dry Hemostatic BandageSummary page 6…ct Code HemCon Bandage and HemCon OTC (K043050) FRO QuikClot ACS (K051955) FRO D-Stat Dry Hemostatic Bandage (K061219) FRO, DXC Syvekexcel (K053300) DXC Stasilon FRTM… | 2006 |
| * | K053300 | SyvekexcelSummary page 6…FRO QuikClot ACS (K051955) FRO D-Stat Dry Hemostatic Bandage (K061219) FRO, DXC Syvekexcel (K053300) DXC Stasilon FRTM page 5-1 === P… | 2006 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142363 | Nustat, Nustat XR | 2015 | 4 |
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 6 companies; a new generation was cleared every 1.2 years on median.
- 1 of the 34 ancestors has a recall of any class.
- Of its descendants, K142363 (Beeken Biomedical, 2015) has gone furthest, with 4 descendants of its own.
- 5 other devices also cite its predicate K043050.
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?
Stasilon FR is a single-use hemostatic wound dressing applied externally with mechanical compression to temporarily control bleeding in lacerations, punctures, abrasions and incisions.
Stasilon FR™ is indicated to temporarily control bleeding in minor cuts, lacerations, punctures, abrasions and incisions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072890 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072890: Stasilon FR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072890
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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