510(k) · Cleared
ClearedNustat, Nustat XR
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beeken Biomedical · QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Cleared on Jan 9, 2015 as substantially equivalent to K072890 (Entegrion, Inc., 2007) and 1 other predicate after a 137-day review. Its family tree reaches back 9 generations to 1995. 4 later devices descend from it.
- Decided
- Jan 9, 2015
- Review
- 137 days
- Class
- Class U
- Product code
- QSY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K953781 (1995). 45 ancestors in all, the oldest K821150 (1982). 4 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK953781 Innovative Technologies Calcium Alginate Wound DressingsInnovative Technologies, Ltd. · 1995
- 5 generations between
- 3 generations backK053300 SyvekexcelMarine Polymer Technologies, Inc. · 2006
- 2 generations backK061219 D-Stat Dry Hemostatic BandageVascular Solutions, Inc. · 2006
- 1 generation backK072890 Stasilon FREntegrion, Inc. · 2007
- This deviceK142363 Nustat, Nustat XRBeeken Biomedical · 2015
- Descendant · cites it directly · 2 of its ownK222189 SiOxD Wound MatrixSioxmed, LLC · 2022
- Descendant · 2 generations on · 1 of its ownK232847 SiOxD Wound MatrixSioxmed, LLC · 2023
- Descendant · 2 generations on · 0 of its ownK241660 SiOxD® Wound MatrixSioxmed, LLC · 2024
- Descendant · cites it directly · 0 of its ownK160578 Nustat XRBeeken Biomedical, LLC · 2016
Show all 9 generations
- Root · 9 generations backK953781 Innovative Technologies Calcium Alginate Wound DressingsInnovative Technologies, Ltd. · 1995
- 8 generations backK980989 3M Tegagen HI Alginate Dressing & 3M Tegagen HG Alginate DressingInnovative Technologies, Ltd. · 1998
- 7 generations backK010933 Seal-on Topical Hempstatic Powder SprayAlltracel Pharma, Ltd. · 2002
- 6 generations backK024107 Femostop Femoral Compression SystemRadi Medical Systems AB · 2002
- 5 generations backK040730 Vascular Solutions D-Stat Clamp Hemostatic ClampVascular Solutions, Inc. · 2004
- 4 generations backK050146 Vascular Solutions D-Stat Clamp AccessoryVascular Solutions, Inc. · 2005
- 3 generations backK053300 SyvekexcelMarine Polymer Technologies, Inc. · 2006
- 2 generations backK061219 D-Stat Dry Hemostatic BandageVascular Solutions, Inc. · 2006
- 1 generation backK072890 Stasilon FREntegrion, Inc. · 2007
- This deviceK142363 Nustat, Nustat XRBeeken Biomedical · 2015
Most influential descendants
Showing 4 of 4 · See all- K222189SiOxD Wound MatrixSioxmed, LLC · 2022 · cites it directly2descendants
- K232847SiOxD Wound MatrixSioxmed, LLC · 2023 · 2 generations on1descendant
- K241660SiOxD® Wound MatrixSioxmed, LLC · 2024 · 2 generations on0descendants
- K160578Nustat XRBeeken Biomedical, LLC · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K953781 | Innovative Technologies Calcium Alginate Wound Dressings | Innovative Technologies, Ltd. | 1995 | — |
| −8 | K980989 | 3M Tegagen HI Alginate Dressing & 3M Tegagen HG Alginate Dressing | Innovative Technologies, Ltd. | 1998 | — |
| −7 | K010933 | Seal-on Topical Hempstatic Powder Spray | Alltracel Pharma, Ltd. | 2002 | — |
| −6 | K024107 | Femostop Femoral Compression System | Radi Medical Systems AB | 2002 | — |
| −5 | K040730 | Vascular Solutions D-Stat Clamp Hemostatic Clamp | Vascular Solutions, Inc. | 2004 | — |
| −4 | K050146 | Vascular Solutions D-Stat Clamp Accessory | Vascular Solutions, Inc. | 2005 | — |
| −3 | K053300 | Syvekexcel | Marine Polymer Technologies, Inc. | 2006 | — |
| −2 | K061219 | D-Stat Dry Hemostatic Bandage | Vascular Solutions, Inc. | 2006 | — |
| −1 | K072890 | Stasilon FR | Entegrion, Inc. | 2007 | — |
| 0 (this device) | K142363 | Nustat, Nustat XR | Beeken Biomedical | 2015 | — |
| +1 | K222189 | SiOxD Wound Matrix | Sioxmed, LLC | 2022 | — |
| +2 | K232847 | SiOxD Wound Matrix | Sioxmed, LLC | 2023 | — |
| +2 | K241660 | SiOxD® Wound Matrix | Sioxmed, LLC | 2024 | — |
| +1 | K160578 | Nustat XR | Beeken Biomedical, LLC | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 4 | 0 |
| 1998 | 5 | 0 |
| 1999 | 2 | 0 |
| 2000 | 3 | 0 |
| 2002 | 5 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 15.0 · 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 |
|---|---|---|---|
| * | K072890 | Stasilon FRSummary page 6…Unclassified Product Code: FRO Predicate Device(s): Primary Predicate K072890 Stasilon FRTM This device has not been subject to a… | 2007 |
| * | K102546 | ChitogauzeSummary page 6…design-related recall. Secondary Predicate K102546 ChitoGauzeTM XR This device has not been subject to a… | 2010 |
What descends from it? (4)
2 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 20 years and passes through 7 companies; a new generation was cleared every 1.2 years on median.
- 3 of the 45 ancestors have a recall of any class.
- Of its descendants, K222189 (Sioxmed, LLC, 2022) has gone furthest, with 2 descendants of its own.
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. 2015, 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?
NuStat is indicated to temporarily control bleeding in minor cuts, lacerations, punctures, abrasions and incisions.
NuStat XR is a single-use hemostatic wound dressing applied externally with mechanical compression to temporarily control bleeding in lacerations, punctures, abrasions and incisions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142363 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142363: Nustat, Nustat XR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142363
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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