510(k) · Cleared
ClearedNexstat Plus and Nexfoam Plus Topical Hemostat Dressing
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 Nov 15, 2012 as substantially equivalent to K102459 (Hemostasis, LLC, 2010) and 1 other predicate after a 56-day review. Its family tree reaches back 6 generations to 1982.
- Decided
- Nov 15, 2012
- Review
- 56 days
- Class
- Class U
- Product code
- QSY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K821150 (1982). 24 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK821150 NU-Gauze SpongeJohnson & Johnson Professionals, Inc. · 1982
- 5 generations backK984069 Entaxis Nasal PackingLes Laboratorires Brothier, S.A. · 1999
- 4 generations backK993362 HylasineBiomatrix, Inc. · 2000
- 3 generations backK033666 HemadermMedafor, Inc. · 2003
- 2 generations backK070211 Traumarrest and Bleedarrest Hemostatic Particles and FoamHemostasis, LLC · 2007
- 1 generation backK102459 Nexstat (TM) Topical Hemostat Powder; Nexfoam (R) Topical SpongeHemostasis, LLC · 2010
- This deviceK122886 Nexstat Plus and Nexfoam Plus Topical Hemostat DressingHemostasis, LLC · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K821150 | NU-Gauze Sponge | Johnson & Johnson Professionals, Inc. | 1982 | — |
| −5 | K984069 | Entaxis Nasal Packing | Les Laboratorires Brothier, S.A. | 1999 | — |
| −4 | K993362 | Hylasine | Biomatrix, Inc. | 2000 | — |
| −3 | K033666 | Hemaderm | Medafor, Inc. | 2003 | — |
| −2 | K070211 | Traumarrest and Bleedarrest Hemostatic Particles and Foam | Hemostasis, LLC | 2007 | — |
| −1 | K102459 | Nexstat (TM) Topical Hemostat Powder; Nexfoam (R) Topical Sponge | Hemostasis, LLC | 2010 | — |
| 0 (this device) | K122886 | Nexstat Plus and Nexfoam Plus Topical Hemostat Dressing | Hemostasis, LLC | 2012 | — |
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 |
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 |
|---|---|---|---|
| * | K102459 | Nexstat (TM) Topical Hemostat Powder; Nexfoam (R) Topical SpongeSummary page 6…nge Special 5lO (k) Hemostasis LLC 10 Sept 19, 2012 cleared for market under 510(k) K102459, with the exception of the cross-linking manufacturing process. The cross-linking process for the manufacture of golysaccharide h… | 2010 |
| * | K033666 | HemadermSummary page 6…ed for the Nextat® Plus and Nexoam 'Plus devices. The new cross linking process utilizes the identical cross linker used in the predicate Medafor MPH® product subject of K033666. All other materials and processes remain the same as Nextat® and Nexoam®. The indications for use remain the same as Nextat® and… | 2003 |
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 30 years and passes through 5 companies; a new generation was cleared every 3.7 years on median.
- None of the 24 ancestors has a recall.
- 2 other devices also cite its predicate K102459.
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. 2012, 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?
Nextat® Plus Topical Hemostat Powder and Nexoam® Plus 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/K122886 · printed Nov 5, 2026
Cite this page
510(k) Report. “K122886: Nexstat Plus and Nexfoam Plus Topical Hemostat Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K122886
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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