510(k) · Cleared
Recalled · 2012Modification to Hemcon Bandage and Hemcon Bandage Otc
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 Aug 6, 2008 as substantially equivalent to K043050 (Hemcon, Inc., 2005) after a 337-day review. Its family tree reaches back 4 generations to 1997. 35 later devices descend from it. It has been recalled 6 times.
- Decided
- Aug 6, 2008
- Review
- 337 days
- Class
- Class U
- Product code
- QSY
- Recalls
- 6
- Predicates
- 1
Its longest line of descent runs back 4 generations to K972914 (1997). 6 ancestors in all. 35 later devices descend from it, 4 citing it directly.
- Root · 4 generations backK972914 Syvek PatchMarine Polymer Technologies, Inc. · 1997
- 3 generations backK023298 Hemcon BandageHemcon, Inc. · 2002
- 2 generations backK030946 Hemcon Bandage Otc; Hemcon Cath/AidHemcon, Inc. · 2003
- 1 generation backK043050 Hemcon Bandage and Hemcon Bandage OtcHemcon, Inc. · 2005
- This deviceK072486 Modification to Hemcon Bandage and Hemcon Bandage OtcHem Con Medical Technologies, Inc. · 2008
- Descendant · cites it directly · 20 of its ownK090026 Chitogauze, Models 130, 131, 263, 264, 265, 266Hem Con Medical Technologies, Inc. · 2009
- Descendant · 2 generations on · 10 of its ownK092357 Chitogauze,2 in X 2 in,8 Ply, 4 in X 4 in 8 Ply, 4 in X 8 in, 8PLY…Hem Con Medical Technologies, Inc. · 2009
- Descendant · 2 generations on · 9 of its ownK102546 ChitogauzeHem Con Medical Technologies, Inc. · 2010
- Descendant · 2 generations on · 7 of its ownK091795 Medtrade Products Celox Trauma GauzeMedtrade Products, Ltd. · 2009
- Descendant · cites it directly · 6 of its ownK120958 Posisep and Posisep X Hemostat DressingsHemostasis, LLC · 2012
Showing 5 of 35 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 35 · See all- K090026Chitogauze, Models 130, 131, 263, 264, 265, 266Hem Con Medical Technologies, Inc. · 2009 · cites it directly20descendants
- K092357Chitogauze,2 in X 2 in,8 Ply, 4 in X 4 in 8 Ply, 4 in X 8 in, 8PLY, 1 in X 4 in, 8PLY…Hem Con Medical Technologies, Inc. · 2009 · 2 generations on10descendants
- K102546ChitogauzeHem Con Medical Technologies, Inc. · 2010 · 2 generations on9descendants
- K091795Medtrade Products Celox Trauma GauzeMedtrade Products, Ltd. · 2009 · 2 generations on7descendants
- K120958Posisep and Posisep X Hemostat DressingsHemostasis, LLC · 2012 · cites it directly6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K972914 | Syvek Patch | Marine Polymer Technologies, Inc. | 1997 | — |
| −3 | K023298 | Hemcon Bandage | Hemcon, Inc. | 2002 | — |
| −2 | K030946 | Hemcon Bandage Otc; Hemcon Cath/Aid | Hemcon, Inc. | 2003 | — |
| −1 | K043050 | Hemcon Bandage and Hemcon Bandage Otc | Hemcon, Inc. | 2005 | — |
| 0 (this device) | K072486 | Modification to Hemcon Bandage and Hemcon Bandage Otc | Hem Con Medical Technologies, Inc. | 2008 | — |
| +1 | K090026 | Chitogauze, Models 130, 131, 263, 264, 265, 266 | Hem Con Medical Technologies, Inc. | 2009 | — |
| +2 | K092357 | Chitogauze,2 in X 2 in,8 Ply, 4 in X 4 in 8 Ply, 4 in X 8 in, 8PLY, 1 in X 4… | Hem Con Medical Technologies, Inc. | 2009 | — |
| +2 | K102546 | Chitogauze | Hem Con Medical Technologies, Inc. | 2010 | — |
| +2 | K091795 | Medtrade Products Celox Trauma Gauze | Medtrade Products, Ltd. | 2009 | — |
| +1 | K120958 | Posisep and Posisep X Hemostat Dressings | Hemostasis, LLC | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 4 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 6 | 0 |
| 2024 | 2 | 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 |
|---|---|---|---|
| * | K043050 | Hemcon Bandage and Hemcon Bandage OtcSummary page 6…TC is indicated for the local management of bleeding such as laceration and minor bleeding. The original HemCon® Bandage and HemCon® Bandage OTC were cleared via 510(k) K043050 on 03 June 2005 to include the description that the bandage provides an antibacterial barrier as demonstrated by AATCC Test Metho… | 2005 |
| † | K990810 | Arglaes-AB Antimicrobial Barrier Film Dressing & Island Dressing | 1999 |
What descends from it? (35)
See all 354 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 3, 2012 | Not classified | Z-1493-2012 | Labeling design | Siemens became aware of a potential safety risk related to the behavior of the 160 MLC when using the "Motion Stop" button followed by "Reset" several times during the treatment of one beam or one segment (issue 1). Additionally, there… |
| May 25, 2011 | Not classified | Z-2789-2011 | Software design | Potential safety issue of possible data loss for the transfer of the same patients treatment data between the LANTIS OIS and the RTT v2.x software and the RT Therapist version 4.1 system |
| Apr 15, 2011 | Not classified | Z-2404-2011 | Other | Siemens became aware of a potential safety risk related to the behavior of the 160 MLC when using the "Motion Stop" button followed by "Reset" several times during the treatment of one beam or one segment. |
| Mar 31, 2011 | Not classified | Z-2216-2011 | Software design | Siemens has become aware of a potential safety issue that may result in mistreatment when customers are configured with the ARTISTE Linac RT Therapist v4.2 in combination with RT Oncologist v.4.2 and use the remote "Online 2D Image Review. |
| Mar 31, 2011 | Not classified | Z-2243-2011 | Software design | Siemens found a potential safety issue related to patient treatment with table offsets on syngo RT Therapist (RTT) 4.1 and 4.2 which could result in dose being delivered to wrong location. |
| Mar 24, 2011 | Not classified | Z-2190-2011 | Pending | When using the ARTISTE Linac and RT Therapist v4.1 along with an imported cropped reference image, the image maybe processed incorrectly, thus resulting in a mistreatment. |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 3.2 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K090026 (Hem Con Medical Technologies, Inc., 2009) has gone furthest, with 20 descendants of its own.
- 5 other devices also cite its predicate K043050.
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. 2008, 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® 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.
The HemCon® Bandage OTC is indicated for the local management of bleeding such as laceration and minor bleeding.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072486 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072486: Modification to Hemcon Bandage and Hemcon Bandage Otc.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072486
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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