510(k) · Cleared
ClearedNexstat (TM) Topical Hemostat Powder; Nexfoam (R) Topical Sponge
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hemostasis, LLC · QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Cleared on Dec 3, 2010 as substantially equivalent to K070211 (Hemostasis, LLC, 2007) and 1 other predicate after a 98-day review. Its family tree reaches back 5 generations to 1982. 9 later devices descend from it.
- Decided
- Dec 3, 2010
- Review
- 98 days
- Class
- Class U
- Product code
- QSY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K821150 (1982). 23 ancestors in all. 9 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK821150 NU-Gauze SpongeJohnson & Johnson Professionals, Inc. · 1982
- 4 generations backK984069 Entaxis Nasal PackingLes Laboratorires Brothier, S.A. · 1999
- 3 generations backK993362 HylasineBiomatrix, Inc. · 2000
- 2 generations backK033666 HemadermMedafor, Inc. · 2003
- 1 generation backK070211 Traumarrest and Bleedarrest Hemostatic Particles and FoamHemostasis, LLC · 2007
- This deviceK102459 Nexstat (TM) Topical Hemostat Powder; Nexfoam (R) Topical SpongeHemostasis, LLC · 2010
- Descendant · cites it directly · 6 of its ownK120958 Posisep and Posisep X Hemostat DressingsHemostasis, LLC · 2012
- Descendant · 2 generations on · 2 of its ownK141704 Novashield Injectable Nasal Packing and StentMedtronic, Inc. · 2014
- Descendant · 2 generations on · 2 of its ownK122494 Posisep and Posisep X Hemostat Dressing/Intranasal SplintHemostasis, LLC · 2013
- Descendant · 3 generations on · 1 of its ownK172179 Chitogel Endoscopic Sinus Surgery KitChitogel, Ltd. · 2017
- Descendant · 4 generations on · 0 of its ownK230142 Epi-Stop Nasal Gel/epistaxis packBiomed Ent, Inc. · 2023
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K120958Posisep and Posisep X Hemostat DressingsHemostasis, LLC · 2012 · cites it directly6descendants
- K141704Novashield Injectable Nasal Packing and StentMedtronic, Inc. · 2014 · 2 generations on2descendants
- K122494Posisep and Posisep X Hemostat Dressing/Intranasal SplintHemostasis, LLC · 2013 · 2 generations on2descendants
- K172179Chitogel Endoscopic Sinus Surgery KitChitogel, Ltd. · 2017 · 3 generations on1descendant
- K230142Epi-Stop Nasal Gel/epistaxis packBiomed Ent, Inc. · 2023 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K821150 | NU-Gauze Sponge | Johnson & Johnson Professionals, Inc. | 1982 | — |
| −4 | K984069 | Entaxis Nasal Packing | Les Laboratorires Brothier, S.A. | 1999 | — |
| −3 | K993362 | Hylasine | Biomatrix, Inc. | 2000 | — |
| −2 | K033666 | Hemaderm | Medafor, Inc. | 2003 | — |
| −1 | K070211 | Traumarrest and Bleedarrest Hemostatic Particles and Foam | Hemostasis, LLC | 2007 | — |
| 0 (this device) | K102459 | Nexstat (TM) Topical Hemostat Powder; Nexfoam (R) Topical Sponge | Hemostasis, LLC | 2010 | — |
| +1 | K120958 | Posisep and Posisep X Hemostat Dressings | Hemostasis, LLC | 2012 | — |
| +2 | K141704 | Novashield Injectable Nasal Packing and Stent | Medtronic, Inc. | 2014 | — |
| +2 | K122494 | Posisep and Posisep X Hemostat Dressing/Intranasal Splint | Hemostasis, LLC | 2013 | — |
| +3 | K172179 | Chitogel Endoscopic Sinus Surgery Kit | Chitogel, Ltd. | 2017 | — |
| +4 | K230142 | Epi-Stop Nasal Gel/epistaxis pack | Biomed Ent, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1997 | 4 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K070211 | Traumarrest and Bleedarrest Hemostatic Particles and FoamSummary page 6…following predicate devices: Manufacturer IBrand Name I 510(k) Number Hemostasis, LLC TrautnArrest®/BleedArrest® K0702 11 Medafor HemaDermTmIMPHm K033666 NexStat Topical Hemostat Powder and NexFoamo Topical Hemostat… | 2007 |
| * | K033666 | HemadermSummary page 6…Name I 510(k) Number Hemostasis, LLC TrautnArrest®/BleedArrest® K0702 11 Medafor HemaDermTmIMPHm K033666 NexStat Topical Hemostat Powder and NexFoamo Topical Hemostat Sponge are technically identical hemostats as the predicates and h… | 2003 |
What descends from it? (9)
3 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 28 years and passes through 5 companies; a new generation was cleared every 3.7 years on median.
- None of the 23 ancestors has a recall.
- Of its descendants, K120958 (Hemostasis, LLC, 2012) has gone furthest, with 6 descendants of its own.
- 4 other devices also cite its predicate K070211.
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. 2010, 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?
NexStat® Topical Hemostat Powder and NexFoam® Topical Hemostat Sponge are intended for use under the care of a health care professional as a topical dressing for the temporary treatment of moderate to severely bleeding wounds such as surgical wounds (post-operative, donor sites, dermatological), cuts and lacerations and for the treatment of mild bleeding from topical ENT surgical wounds and nosebleeds. It is also indicated for control of bleeding from the skin at percutaneous needle access, vascular access and percutaneous catheter access sites.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102459 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102459: Nexstat (TM) Topical Hemostat Powder; Nexfoam (R) Topical Sponge.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102459
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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