510(k) · Cleared
ClearedHemcon Bandage
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hemcon, Inc. · QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Cleared on Nov 4, 2002 as substantially equivalent to K002550 (Marine Polymer Technologies, Inc., 2000) and 1 other predicate after a 32-day review. Its family tree reaches back 1 generation to 1997. 74 later devices descend from it.
- Decided
- Nov 4, 2002
- Review
- 32 days
- Class
- Class U
- Product code
- QSY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K972914 (1997). 2 ancestors in all. 74 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK972914 Syvek PatchMarine Polymer Technologies, Inc. · 1997
- This deviceK023298 Hemcon BandageHemcon, Inc. · 2002
- Descendant · cites it directly · 56 of its ownK030946 Hemcon Bandage Otc; Hemcon Cath/AidHemcon, Inc. · 2003
- Descendant · cites it directly · 55 of its ownK043050 Hemcon Bandage and Hemcon Bandage OtcHemcon, Inc. · 2005
- Descendant · 2 generations on · 35 of its ownK072486 Modification to Hemcon Bandage and Hemcon Bandage OtcHem Con Medical Technologies, Inc. · 2008 · Recalled
- Descendant · cites it directly · 27 of its ownK061079 Medtrade Products Celox Topical Hemostatic Granules, Medtrade…Medtrade Products, Ltd. · 2006
- Descendant · 2 generations on · 22 of its ownK071519 Hemcon Chitoflex-Surgical DressingHemcon, Inc. · 2007
Showing 5 of 74 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 74 · See all- K030946Hemcon Bandage Otc; Hemcon Cath/AidHemcon, Inc. · 2003 · cites it directly56descendants
- K043050Hemcon Bandage and Hemcon Bandage OtcHemcon, Inc. · 2005 · cites it directly55descendants
- K072486Modification to Hemcon Bandage and Hemcon Bandage OtcHem Con Medical Technologies, Inc. · 2008 · 2 generations on35descendants
- K061079Medtrade Products Celox Topical Hemostatic Granules, Medtrade Products Celox 762…Medtrade Products, Ltd. · 2006 · cites it directly27descendants
- K071519Hemcon Chitoflex-Surgical DressingHemcon, Inc. · 2007 · 2 generations on22descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K972914 | Syvek Patch | Marine Polymer Technologies, Inc. | 1997 | — |
| 0 (this device) | K023298 | Hemcon Bandage | Hemcon, Inc. | 2002 | — |
| +1 | K030946 | Hemcon Bandage Otc; Hemcon Cath/Aid | Hemcon, Inc. | 2003 | — |
| +1 | K043050 | Hemcon Bandage and Hemcon Bandage Otc | Hemcon, Inc. | 2005 | — |
| +2 | K072486 | Modification to Hemcon Bandage and Hemcon Bandage Otc | Hem Con Medical Technologies, Inc. | 2008 | 6 |
| +1 | K061079 | Medtrade Products Celox Topical Hemostatic Granules, Medtrade Products Celox… | Medtrade Products, Ltd. | 2006 | — |
| +2 | K071519 | Hemcon Chitoflex-Surgical Dressing | Hemcon, Inc. | 2007 | — |
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 |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 5 | 0 |
| 2009 | 5 | 0 |
| 2010 | 4 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 4 | 0 |
| 2014 | 4 | 0 |
| 2015 | 4 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 5 | 0 |
| 2019 | 4 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 8 | 0 |
| 2024 | 5 | 0 |
| 2025 | 3 | 0 |
| 2026 | 2 | 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.
What descends from it? (74)
See all 745 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K030946 | Hemcon Bandage Otc; Hemcon Cath/Aid | 2003 | 56 |
| K043050 | Hemcon Bandage and Hemcon Bandage Otc | 2005 | 55 |
| K061079 | Medtrade Products Celox Topical Hemostatic Granules, Medtrade Products Celox 762… | 2006 | 27 |
| K150916 | HemCon Bandage PRO, HemCon Patch PRO, HemCon Strip PRO, HemCon Strip First Aid PRO… | 2015 | 3 |
| K060363 | Hemcon Dental Dressing, 1 Dressing, 4 Dressing, 1 Dressing, Box of 12, 4 Dressing, Box… | 2006 | 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?
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?
HemCon™ Bandage is a hemostatic dressing for the external temporary control of severely bleeding wounds intended for emergency use. In addition, the HemCon™ Bandage also controls bleeding in patients following hemodialysis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023298 · printed Nov 4, 2026
Cite this page
510(k) Report. “K023298: Hemcon Bandage.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K023298
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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