510(k) · Cleared
ClearedHemcon Hemostatic Gel
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 Apr 12, 2012 as substantially equivalent to K072681 (Lifescience Plus, Inc., 2007) and 1 other predicate after a 254-day review. Its family tree reaches back 4 generations to 1995.
- Decided
- Apr 12, 2012
- Review
- 254 days
- Class
- Class U
- Product code
- QSY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K953781 (1995). 6 ancestors in all. No later device cites it as a predicate yet.
- 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 deviceK112215 Hemcon Hemostatic GelHemcon Medical Technologies Europe, Ltd. · 2012
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) | K112215 | Hemcon Hemostatic Gel | Hemcon Medical Technologies Europe, Ltd. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 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? (2)
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 |
|---|---|---|---|
| * | K072681 | Bloodstop Hemostatic Gauze; IX Hemostatic GauzeSummary page 5…n No: Unclassified Product Code: FRO Predicate Device(s): BloodSTOP Th (K072681) Sa-nTM Hemostatic Powder Spray… | 2007 |
| * | K010933 | Seal-on Topical Hempstatic Powder SpraySummary page 5…BloodSTOP Th (K072681) Sa-nTM Hemostatic Powder Spray (K01 0933) Company Name: HemCon Medical Technologies Europe Ltd. Company Address:… | 2002 |
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 17 years and passes through 4 companies; a new generation was cleared every 4.4 years on median.
- None of the 6 ancestors has a recall.
- 4 other devices also cite its predicate K072681.
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. 2012, 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 GuardaGel™ is intended for management of wounds and for emergency external use for the temporary control of minor bleeding from skin surface wounds.
HemCon GuardaGel™ First Aid is intended for management of wounds and for emergency external use for the temporary control of minor bleeding from minor topical cuts and lacerations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112215 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112215: Hemcon Hemostatic Gel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112215
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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