510(k) · Cleared
ClearedHemcon Bandage, Hemcon Bandage Otc, Hemcon Chitoflex-Surgical Dressing
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 May 15, 2008 as substantially equivalent to K043050 (Hemcon, Inc., 2005) and 5 other predicates after a 52-day review. Its family tree reaches back 6 generations to 1990. 11 later devices descend from it.
- Decided
- May 15, 2008
- Review
- 52 days
- Class
- Class U
- Product code
- QSY
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 6 generations to K896068 (1990). 42 ancestors in all, the oldest K821150 (1982). 11 later devices descend from it, 4 citing it directly.
- Root · 6 generations backK896068 Tipstop (TM)Gambro-Hospal, Inc. · 1990
- 5 generations backK982818 Hospal TipstopGambro Healthcare · 1998
- 4 generations backK012293 Vascular Solutions Duett Flowable HemostatVascular Solutions, Inc. · 2002
- 3 generations backK030836 D-Stat-Dry Hemostatic Bandage; D-Stat Radial Hemostatic BandageVascular Solutions, Inc. · 2003 · Recalled
- 2 generations backK050511 Thrombigel Thrombin/Gelatin Foam HemostatVascular Solutions, Inc. · 2005
- 1 generation backK072900 Excelarrest FoamHemostasis, LLC · 2007
- This deviceK080818 Hemcon Bandage, Hemcon Bandage Otc, Hemcon Chitoflex-Surgical DressingHem Con Medical Technologies, Inc. · 2008
- Descendant · cites it directly · 5 of its ownK090620 Quikclot Inteventional, Model P/N 182Z-Medica Corporation · 2009
- Descendant · cites it directly · 3 of its ownK150916 HemCon Bandage PRO, HemCon Patch PRO, HemCon Strip PRO, HemCon Strip…Hem Con Medical Technologies, Inc. · 2015
- Descendant · cites it directly · 2 of its ownK093519 Medtrade Products Celox Vascular Topical Hemostatic Granules on SheetMedtrade Products, Ltd. · 2010
- Descendant · 2 generations on · 1 of its ownK182811 gel-e Flex+Gel-E, Inc. · 2019
- Descendant · 2 generations on · 1 of its ownK120782 Interventional Hemostatic BandageZ-Medica Corporation · 2013
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K090620Quikclot Inteventional, Model P/N 182Z-Medica Corporation · 2009 · cites it directly5descendants
- K150916HemCon Bandage PRO, HemCon Patch PRO, HemCon Strip PRO, HemCon Strip First Aid PRO…Hem Con Medical Technologies, Inc. · 2015 · cites it directly3descendants
- K093519Medtrade Products Celox Vascular Topical Hemostatic Granules on SheetMedtrade Products, Ltd. · 2010 · cites it directly2descendants
- K182811gel-e Flex+Gel-E, Inc. · 2019 · 2 generations on1descendant
- K120782Interventional Hemostatic BandageZ-Medica Corporation · 2013 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K896068 | Tipstop (TM) | Gambro-Hospal, Inc. | 1990 | — |
| −5 | K982818 | Hospal Tipstop | Gambro Healthcare | 1998 | — |
| −4 | K012293 | Vascular Solutions Duett Flowable Hemostat | Vascular Solutions, Inc. | 2002 | — |
| −3 | K030836 | D-Stat-Dry Hemostatic Bandage; D-Stat Radial Hemostatic Bandage | Vascular Solutions, Inc. | 2003 | 3 |
| −2 | K050511 | Thrombigel Thrombin/Gelatin Foam Hemostat | Vascular Solutions, Inc. | 2005 | — |
| −1 | K072900 | Excelarrest Foam | Hemostasis, LLC | 2007 | — |
| 0 (this device) | K080818 | Hemcon Bandage, Hemcon Bandage Otc, Hemcon Chitoflex-Surgical Dressing | Hem Con Medical Technologies, Inc. | 2008 | — |
| +1 | K090620 | Quikclot Inteventional, Model P/N 182 | Z-Medica Corporation | 2009 | — |
| +1 | K150916 | HemCon Bandage PRO, HemCon Patch PRO, HemCon Strip PRO, HemCon Strip First Aid… | Hem Con Medical Technologies, Inc. | 2015 | — |
| +1 | K093519 | Medtrade Products Celox Vascular Topical Hemostatic Granules on Sheet | Medtrade Products, Ltd. | 2010 | — |
| +2 | K182811 | gel-e Flex+ | Gel-E, Inc. | 2019 | — |
| +2 | K120782 | Interventional Hemostatic Bandage | Z-Medica Corporation | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1983 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1997 | 4 | 0 |
| 1998 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 5 | 0 |
| 2001 | 4 | 0 |
| 2002 | 3 | 0 |
| 2003 | 4 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 3 | 0 |
| 2021 | 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? (6)
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…Product Code: FRO Establishment Registration Number: 9053189 General Description: The HemCon Bandage and HemCon Bandage OTC were cleared in K043050 on June 3, 2005. Additionally, the Hemcon ChitoFlex-Surgical dressing was cleared in K071519 on August 6, 2007 for temporary surg… | 2005 |
| * | K071519 | Hemcon Chitoflex-Surgical DressingSummary page 6…eral Description: The HemCon Bandage and HemCon Bandage OTC were cleared in K043050 on June 3, 2005. Additionally, the Hemcon ChitoFlex-Surgical dressing was cleared in K071519 on August 6, 2007 for temporary surgical use. With this 510(k), the bandage remains unchanged; this application solely expands th… | 2007 |
| * | K072900 | Excelarrest FoamSummary page 6…evices include: HemnCon Bandage (K043050, cleared June 3, 2005), HemCon ChitoFlex-Surgical (KO71 519, cleared August 6, 2007) Hemnostasis, LLC Corporation's ExcelArrest (K072900, cleared Oct. 26, 2007), Perclose/Abbott Labs' Chito-Seal (K021062, cleared Aug 23, 2002), Scion Cardio-Vascular, Inc's (Medtroni… | 2007 |
| * | K021062 | Chito-SealSummary page 6…mCon ChitoFlex-Surgical (KO71 519, cleared August 6, 2007) Hemnostasis, LLC Corporation's ExcelArrest (K072900, cleared Oct. 26, 2007), Perclose/Abbott Labs' Chito-Seal (K021062, cleared Aug 23, 2002), Scion Cardio-Vascular, Inc's (Medtronic) Clo-Sur (plus) P.A.D. (K032986, cleared Mar 1, 2004) and Medafor… | 2002 |
| * | K032986 | Clo-Surplusp.a.D.Summary page 6…rrest (K072900, cleared Oct. 26, 2007), Perclose/Abbott Labs' Chito-Seal (K021062, cleared Aug 23, 2002), Scion Cardio-Vascular, Inc's (Medtronic) Clo-Sur (plus) P.A.D. (K032986, cleared Mar 1, 2004) and Medafor, Inc.'s Hemaderm containging MPH (Microporous Polysaccharide Hemospheres) (K033666, cleared Dec… | 2004 |
| * | K033666 | HemadermSummary page 6…o-Vascular, Inc's (Medtronic) Clo-Sur (plus) P.A.D. (K032986, cleared Mar 1, 2004) and Medafor, Inc.'s Hemaderm containging MPH (Microporous Polysaccharide Hemospheres) (K033666, cleared Dec. 17, 2003). Page 6 of 9 HemCon, Inc., Bandage Add… | 2003 |
What descends from it? (11)
See all 114 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)
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 18 years and passes through 5 companies; a new generation was cleared every 2.5 years on median.
- 2 of the 42 ancestors have a recall of any class.
- Of its descendants, K090620 (Z-Medica Corporation, 2009) has gone furthest, with 5 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 ChitoFlex TM-Surgical is intended for use as a dressing for local management of bleeding wounds such as cuts, lacerations and abrasions. It may also be used for temporary treatment of severely bleeding wounds such as surgical wounds (operative, postoperative, dermatalogical, etc.) and traumatic injuries. The dressing is also indicated for the control of bleeding from the skin at percutaneous needle access, vascular access and percutaneous catheter…
Read the full statement (125 words)
HemCon ChitoFlex TM-Surgical is intended for use as a dressing for local management of bleeding wounds such as cuts, lacerations and abrasions.
It may also be used for temporary treatment of severely bleeding wounds such as surgical wounds (operative, postoperative, dermatalogical, etc.) and traumatic injuries.
The dressing is also indicated for the control of bleeding from the skin at percutaneous needle access, vascular access and percutaneous catheter access sites.
The 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 dressing is also indicated for the control of bleeding from the skin at percutaneous needle access, vascular access and percutaneous catheter access sites.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080818 · printed Nov 5, 2026
Cite this page
510(k) Report. “K080818: Hemcon Bandage, Hemcon Bandage Otc, Hemcon Chitoflex-Surgical Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K080818
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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