510(k) · Cleared
ClearedAx-Surgi Surgical Hemostat
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advamedica, Inc. · POD Temporary, Internal Use Hemostatic
Cleared on Jan 5, 2023 as substantially equivalent to K200167 (Z-Medica, LLC, 2020) after a 463-day review. Its family tree reaches back 2 generations to 2017.
- Decided
- Jan 5, 2023
- Review
- 463 days
- Class
- Class II
- Product code
- POD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN160012 (2017). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 |
|---|---|---|---|
| * | K200167 | QuikClot Control+Summary page 4…lation Number: 21 CFR 878.4454 Product Code: POD 4. PREDICATE DEVICES Primary Predicate- QuikClot Control+ Hemostatic Dressing – K200167 Reference Predicate – Axiostat Patch K202830 5. DEVICE DESCRIPTION Advamedica Inc., Traditional 510(k)… | 2020 |
| † | K202830 | Axiostat Patch | 2021 |
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 6 years and passes through 2 companies; a new generation was cleared every 2.8 years on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K200167.
How does its category compare?
All POD devicesPOD Temporary, Internal Use Hemostatic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?
The Ax-Surgi Surgical Hemostat 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/K213198 · printed Nov 4, 2026
Cite this page
510(k) Report. “K213198: Ax-Surgi Surgical Hemostat.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K213198
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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