510(k) · Cleared
ClearedGuardiva Antimicrobial Haemostatic IV Dressing, 1 in/ 4MM, Sterile, Guard Iva Antimicrobial Haemostatic IV Dressing, 1 I
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hemcon Medical Technologies Europe, Ltd. · QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Cleared on Jun 8, 2010 as substantially equivalent to K003229 (Integra Lifesciences Corp., 2001) and 2 other predicates after a 187-day review. Its family tree reaches back 4 generations to 1995. 1 later device descends from it.
- Decided
- Jun 8, 2010
- Review
- 187 days
- Class
- Class U
- Product code
- QSY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K953781 (1995). 8 ancestors in all, the oldest K895920 (1991). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK953781 Innovative Technologies Calcium Alginate Wound DressingsInnovative Technologies, Ltd. · 1995
- 3 generations backK980989 3M Tegagen HI Alginate Dressing & 3M Tegagen HG Alginate DressingInnovative Technologies, Ltd. · 1998
- 2 generations backK010933 Seal-on Topical Hempstatic Powder SprayAlltracel Pharma, Ltd. · 2002
- 1 generation backK072681 Bloodstop Hemostatic Gauze; IX Hemostatic GauzeLifescience Plus, Inc. · 2007
- This deviceK093729 Guardiva Antimicrobial Haemostatic IV Dressing, 1 in/ 4MM, Sterile…Hemcon Medical Technologies Europe, Ltd. · 2010
- Descendant · cites it directly · 0 of its ownK121485 Guardiva Antimicrobial Haemstatic IV DressingHemcon Medical Technologies Europe, Ltd. · 2012
Most influential descendants
Showing 1 of 1 · See all- K121485Guardiva Antimicrobial Haemstatic IV DressingHemcon Medical Technologies Europe, Ltd. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K953781 | Innovative Technologies Calcium Alginate Wound Dressings | Innovative Technologies, Ltd. | 1995 | — |
| −3 | K980989 | 3M Tegagen HI Alginate Dressing & 3M Tegagen HG Alginate Dressing | Innovative Technologies, Ltd. | 1998 | — |
| −2 | K010933 | Seal-on Topical Hempstatic Powder Spray | Alltracel Pharma, Ltd. | 2002 | — |
| −1 | K072681 | Bloodstop Hemostatic Gauze; IX Hemostatic Gauze | Lifescience Plus, Inc. | 2007 | — |
| 0 (this device) | K093729 | Guardiva Antimicrobial Haemostatic IV Dressing, 1 in/ 4MM, Sterile, Guard Iva… | Hemcon Medical Technologies Europe, Ltd. | 2010 | — |
| +1 | K121485 | Guardiva Antimicrobial Haemstatic IV Dressing | Hemcon Medical Technologies Europe, Ltd. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 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? (3)
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 |
|---|---|---|---|
| * | K003229 | Biopatch Antimicrobial DressingSummary page 5…act Fax: Contact Person (US): Contact Phone: Contact Fax: Date of Preparation: 510(k) Summary EMAIL: GuardlVa™ Dressing, Wounds, Drug Unclassified FRO BioPatch® (K003229) BloodSTOP™ (K072681) Seal-On™ Hemostatic Powder Spray (K010933) JUN =8 2010 HemCon Medical Technologies Europe Ltd. Alltrace… | 2001 |
| * | K072681 | Bloodstop Hemostatic Gauze; IX Hemostatic GauzeSummary page 5…n (US): Contact Phone: Contact Fax: Date of Preparation: 510(k) Summary EMAIL: GuardlVa™ Dressing, Wounds, Drug Unclassified FRO BioPatch® (K003229) BloodSTOP™ (K072681) Seal-On™ Hemostatic Powder Spray (K010933) JUN =8 2010 HemCon Medical Technologies Europe Ltd. Alltracel House, Church Place,… | 2007 |
| * | K010933 | Seal-on Topical Hempstatic Powder SpraySummary page 5…f Preparation: 510(k) Summary EMAIL: GuardlVa™ Dressing, Wounds, Drug Unclassified FRO BioPatch® (K003229) BloodSTOP™ (K072681) Seal-On™ Hemostatic Powder Spray (K010933) JUN =8 2010 HemCon Medical Technologies Europe Ltd. Alltracel House, Church Place, Sallynoggin Dublin, Ireland Keith Real Ex… | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121485 | Guardiva Antimicrobial Haemstatic IV Dressing | 2012 | 0 |
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 15 years and passes through 4 companies; a new generation was cleared every 3.6 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K121485 (Hemcon Medical Technologies Europe, Ltd., 2012) has gone furthest, with 0 descendants of its own.
- 7 other devices also cite its predicate K003229.
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. 2010, 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?
The HemCon GuardlVa Antimicrobial Hemostatic IV Dressing is intended for use as a hydrophilic wound dressing to absorb exudate, cover and protect catheter sites. Common applications include IV catheters, other intravenous catheters and percutaneous devices. It is also indicated for control of surface bleeding from percutaneous catheters and vascular access sites.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K093729 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093729: Guardiva Antimicrobial Haemostatic IV Dressing, 1 in/ 4MM, Sterile, Guard Iva Antimicrobial Haemostatic IV Dressing, 1 I.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093729
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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