510(k) · Cleared
ClearedBloxx Rapid Clotting Agent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Crosslink-D, Inc. · QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Cleared on Aug 2, 2006 as substantially equivalent to K013225 (Medafor, Inc., 2001) after a 44-day review. Its family tree reaches back 1 generation to 2001. 4 later devices descend from it.
- Decided
- Aug 2, 2006
- Review
- 44 days
- Class
- Class U
- Product code
- QSY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K013225 (2001). 4 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK013225 Instaclot for Otc Use, Traumasstat for Prescription UseMedafor, Inc. · 2001
- This deviceK061722 Bloxx Rapid Clotting AgentCrosslink-D, Inc. · 2006
- Descendant · cites it directly · 3 of its ownK082703 MRDH BandageMarine Polymer Technologies, Inc. · 2008
- Descendant · 2 generations on · 2 of its ownK103641 GuardacareHem Con Medical Technologies, Inc. · 2011
- Descendant · 3 generations on · 1 of its ownK140757 D2 Hemostantic DressingZ-Medica, LLC · 2014
- Descendant · 4 generations on · 0 of its ownK243553 QuikClot Control+ Hemostatic DeviceTeleflex Medical · 2025
Most influential descendants
Showing 4 of 4 · See all- K082703MRDH BandageMarine Polymer Technologies, Inc. · 2008 · cites it directly3descendants
- K103641GuardacareHem Con Medical Technologies, Inc. · 2011 · 2 generations on2descendants
- K140757D2 Hemostantic DressingZ-Medica, LLC · 2014 · 3 generations on1descendant
- K243553QuikClot Control+ Hemostatic DeviceTeleflex Medical · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K013225 | Instaclot for Otc Use, Traumasstat for Prescription Use | Medafor, Inc. | 2001 | — |
| 0 (this device) | K061722 | Bloxx Rapid Clotting Agent | Crosslink-D, Inc. | 2006 | — |
| +1 | K082703 | MRDH Bandage | Marine Polymer Technologies, Inc. | 2008 | — |
| +2 | K103641 | Guardacare | Hem Con Medical Technologies, Inc. | 2011 | — |
| +3 | K140757 | D2 Hemostantic Dressing | Z-Medica, LLC | 2014 | — |
| +4 | K243553 | QuikClot Control+ Hemostatic Device | Teleflex Medical | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2025 | 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 15.1 · 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 |
|---|---|---|---|
| * | K013225 | Instaclot for Otc Use, Traumasstat for Prescription UseSummary page 5…DEVICE TraumadeXTm/B3leed-XTM containing HemadeXTM Clotting Beads Medlafor, Inc. (Minneapolis, MN) K013225 (Dec. 26, 2001) DEVICE DESCRIPTION BloXXTm Rapid Clonting Agent is a hemostatic gauze pad treated wi… | 2001 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082703 | MRDH Bandage | 2008 | 3 |
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?
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.
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?
BloxxTM Rapid Clotting Agent is a hemostatic gauze pad intended for use as a topical dressing for local management of bleeding wounds such as cuts, lacerations and abrasions.
It may also be used for the temporary treatment of severely bleeding wounds such as surgical wounds (operative, post operative, donor sites, dermatological, etc.), and traumatic injuries.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061722 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061722: Bloxx Rapid Clotting Agent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061722
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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