510(k) · Cleared
ClearedGuardacare
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hem Con Medical Technologies, Inc. · QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Cleared on Jun 16, 2011 as substantially equivalent to K082703 (Marine Polymer Technologies, Inc., 2008) after a 185-day review. Its family tree reaches back 3 generations to 2001. 2 later devices descend from it.
- Decided
- Jun 16, 2011
- Review
- 185 days
- Class
- Class U
- Product code
- QSY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K013225 (2001). 4 ancestors in all, the oldest K002550 (2000). 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK013225 Instaclot for Otc Use, Traumasstat for Prescription UseMedafor, Inc. · 2001
- 2 generations backK061722 Bloxx Rapid Clotting AgentCrosslink-D, Inc. · 2006
- 1 generation backK082703 MRDH BandageMarine Polymer Technologies, Inc. · 2008
- This deviceK103641 GuardacareHem Con Medical Technologies, Inc. · 2011
- Descendant · cites it directly · 1 of its ownK140757 D2 Hemostantic DressingZ-Medica, LLC · 2014
- Descendant · 2 generations on · 0 of its ownK243553 QuikClot Control+ Hemostatic DeviceTeleflex Medical · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K013225 | Instaclot for Otc Use, Traumasstat for Prescription Use | Medafor, Inc. | 2001 | — |
| −2 | K061722 | Bloxx Rapid Clotting Agent | Crosslink-D, Inc. | 2006 | — |
| −1 | K082703 | MRDH Bandage | Marine Polymer Technologies, Inc. | 2008 | — |
| 0 (this device) | K103641 | Guardacare | Hem Con Medical Technologies, Inc. | 2011 | — |
| +1 | K140757 | D2 Hemostantic Dressing | Z-Medica, LLC | 2014 | — |
| +2 | K243553 | QuikClot Control+ Hemostatic Device | Teleflex Medical | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 15.0 · 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 |
|---|---|---|---|
| * | K082703 | MRDH BandageSummary page 5…Wound Dressing Classification Name: Dressing Product Code: FRO/KMF Predicate Device(s): mRDH Bandage - K082703 Company Name: HemCon Medical Technologies, Inc. Company Address: 10575 SW Cascade… | 2008 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140757 | D2 Hemostantic Dressing | 2014 | 1 |
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 10 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K140757 (Z-Medica, LLC, 2014) has gone furthest, with 1 descendant of its own.
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. 2011, 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?
HemCon GuardaCareT'XR is a hemostatic dressing intended for the temporary 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/K103641 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103641: Guardacare.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103641
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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