510(k) · Cleared
Recalled · Class II · 2021NuStat
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beeken Biomedical, LLC · POD Temporary, Internal Use Hemostatic
Cleared on Sep 25, 2019 as substantially equivalent to DEN160012 (Z-Medica, LLC, 2017) after a 310-day review. Its family tree reaches back 1 generation to 2017. It has been recalled once.
- Decided
- Sep 25, 2019
- Review
- 310 days
- Class
- Class II
- Product code
- POD
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN160012 (2017). No later device cites it as a predicate yet.
- Root · 1 generation backDEN160012 D2 DressingZ-Medica, LLC · 2017
- This deviceK183190 NuStatBeeken Biomedical, LLC · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN160012 | D2 Dressing | Z-Medica, LLC | 2017 | — |
| 0 (this device) | K183190 | NuStat | Beeken Biomedical, LLC | 2019 | — |
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 POD? 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 POD device
- #1 K243553 QuikClot Control+ Hemostatic Devicescore 10.2 · 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? (1)
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 |
|---|---|---|---|
| * | DEN160012 | D2 DressingSummary page 4…at the site of application. The radiopaque element allows for detection via x-ray. Predicate Device: Z-Medica, LLC’s D2 Dressing (DEN160012), decision date June 30, 2017. Beeken Biomedical 510k) Summary NuStat K183190… | 2017 |
| † | K160578 | Nustat XR | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 14, 2021 | Class II | Z-0309-2022 | Under Investigation by firm | Endotoxin levels exceeded allowable limits. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 1 other device also cites its predicate DEN160012.
How does its category compare?
All POD devicesPOD Temporary, Internal Use Hemostatic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · POD
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · POD
Too few POD 510(k)s in any year since 2007 to give a median.
Recalls per year · POD
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · POD
1in 2025
MAUDE reports naming product code POD, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 1 | 1 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 1 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
NuStat is indicated for temporary control of internal organ space bleeding for patients displaying class III or class IV bleeding. It may also be used for control of severely bleeding wounds such as surgical wounds and traumatic injuries.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183190 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183190: NuStat.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183190
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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