510(k) · Cleared
ClearedMfuse (MS001)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Machina Medical, Inc. · QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Cleared on Dec 15, 2025 as substantially equivalent to K240713 (Cresilon, Inc., 2024) after a 314-day review. Its family tree reaches back 6 generations to 2000.
- Decided
- Dec 15, 2025
- Review
- 314 days
- Class
- Class U
- Product code
- QSY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K002550 (2000). 13 ancestors in all, the oldest K972914 (1997). No later device cites it as a predicate yet.
- Root · 6 generations backK002550 RDH BandageMarine Polymer Technologies, Inc. · 2000
- 5 generations backK013390 QuickclotOn Site Gas Systems, Inc. · 2002
- 4 generations backK061079 Medtrade Products Celox Topical Hemostatic Granules, Medtrade…Medtrade Products, Ltd. · 2006
- 3 generations backK080097 Medtrade Products Celox Hemostatic Granules on SheetMedtrade Products, Ltd. · 2008
- 2 generations backK113560 Celox Gauze ProMedtrade Products, Ltd. · 2012
- 1 generation backK240713 Traumagel®Cresilon, Inc. · 2024
- This deviceK250319 Mfuse (MS001)Machina Medical, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K002550 | RDH Bandage | Marine Polymer Technologies, Inc. | 2000 | — |
| −5 | K013390 | Quickclot | On Site Gas Systems, Inc. | 2002 | — |
| −4 | K061079 | Medtrade Products Celox Topical Hemostatic Granules, Medtrade Products Celox… | Medtrade Products, Ltd. | 2006 | — |
| −3 | K080097 | Medtrade Products Celox Hemostatic Granules on Sheet | Medtrade Products, Ltd. | 2008 | — |
| −2 | K113560 | Celox Gauze Pro | Medtrade Products, Ltd. | 2012 | — |
| −1 | K240713 | Traumagel® | Cresilon, Inc. | 2024 | — |
| 0 (this device) | K250319 | Mfuse (MS001) | Machina Medical, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2002 | 2 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 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? (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 |
|---|---|---|---|
| * | K240713 | Traumagel®Summary page 5…QSY Regulation Number: Not Applicable Predicate Devices: Primary TRAUMAGEL® (K240713) Device Description MFUSE™ is a sterile, single-use, disposable device designed to stop bleeding by creating an barrier over t… | 2024 |
| † | K061079 | Medtrade Products Celox Topical Hemostatic Granules, Medtrade Products Celox 762… | 2006 |
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 25 years and passes through 5 companies; a new generation was cleared every 4.0 years on median.
- None of the 13 ancestors has a recall.
- 1 other device also cites its predicate K240713.
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. 2025, 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?
MFUSE™ is indicated for temporary external use for controlling moderate to severe bleeding.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250319 · printed Nov 4, 2026
Cite this page
510(k) Report. “K250319: Mfuse (MS001).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K250319
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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