510(k) · Cleared
ClearedHemCon Bandage PRO, HemCon Patch PRO, HemCon Strip PRO, HemCon Strip First Aid PRO, ChitoFlex PRO
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 Nov 10, 2015 as substantially equivalent to K080818 (Hem Con Medical Technologies, Inc., 2008) and 8 other predicates after a 218-day review. Its family tree reaches back 7 generations to 1990. 3 later devices descend from it.
- Decided
- Nov 10, 2015
- Review
- 218 days
- Class
- Class U
- Product code
- QSY
- Recalls
- None
- Predicates
- 9
Its longest line of descent runs back 7 generations to K896068 (1990). 46 ancestors in all, the oldest K821150 (1982). 3 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK896068 Tipstop (TM)Gambro-Hospal, Inc. · 1990
- 6 generations backK982818 Hospal TipstopGambro Healthcare · 1998
- 5 generations backK012293 Vascular Solutions Duett Flowable HemostatVascular Solutions, Inc. · 2002
- 4 generations backK030836 D-Stat-Dry Hemostatic Bandage; D-Stat Radial Hemostatic BandageVascular Solutions, Inc. · 2003 · Recalled
- 3 generations backK050511 Thrombigel Thrombin/Gelatin Foam HemostatVascular Solutions, Inc. · 2005
- 2 generations backK072900 Excelarrest FoamHemostasis, LLC · 2007
- 1 generation backK080818 Hemcon Bandage, Hemcon Bandage Otc, Hemcon Chitoflex-Surgical DressingHem Con Medical Technologies, Inc. · 2008
- This deviceK150916 HemCon Bandage PRO, HemCon Patch PRO, HemCon Strip PRO, HemCon Strip…Hem Con Medical Technologies, Inc. · 2015
- Descendant · cites it directly · 1 of its ownK182811 gel-e Flex+Gel-E, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK202830 Axiostat PatchAdvamedica, Inc. · 2021
- Descendant · 2 generations on · 0 of its ownK192667 gel-e Flex+ gel OTCGel-E, Inc. · 2019
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K896068 | Tipstop (TM) | Gambro-Hospal, Inc. | 1990 | — |
| −6 | K982818 | Hospal Tipstop | Gambro Healthcare | 1998 | — |
| −5 | K012293 | Vascular Solutions Duett Flowable Hemostat | Vascular Solutions, Inc. | 2002 | — |
| −4 | K030836 | D-Stat-Dry Hemostatic Bandage; D-Stat Radial Hemostatic Bandage | Vascular Solutions, Inc. | 2003 | 3 |
| −3 | K050511 | Thrombigel Thrombin/Gelatin Foam Hemostat | Vascular Solutions, Inc. | 2005 | — |
| −2 | K072900 | Excelarrest Foam | Hemostasis, LLC | 2007 | — |
| −1 | K080818 | Hemcon Bandage, Hemcon Bandage Otc, Hemcon Chitoflex-Surgical Dressing | Hem Con Medical Technologies, Inc. | 2008 | — |
| 0 (this device) | K150916 | HemCon Bandage PRO, HemCon Patch PRO, HemCon Strip PRO, HemCon Strip First Aid… | Hem Con Medical Technologies, Inc. | 2015 | — |
| +1 | K182811 | gel-e Flex+ | Gel-E, Inc. | 2019 | — |
| +1 | K202830 | Axiostat Patch | Advamedica, Inc. | 2021 | — |
| +2 | K192667 | gel-e Flex+ gel OTC | Gel-E, Inc. | 2019 | — |
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 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 2 | 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? (9)
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 |
|---|---|---|---|
| * | K080818 | Hemcon Bandage, Hemcon Bandage Otc, Hemcon Chitoflex-Surgical DressingSummary page 10…: FRO Regulatory Class: Unclassified III. Predicate Device(s): Predicate Devices: HemCon Bandage (K080818, K072486, K071519, K043050, K030946, K023298) Cl… | 2008 |
| * | K072486 | Modification to Hemcon Bandage and Hemcon Bandage OtcSummary page 10…FRO Regulatory Class: Unclassified III. Predicate Device(s): Predicate Devices: HemCon Bandage (K080818, K072486, K071519, K043050, K030946, K023298) Clo-Sur Pad… | 2008 |
| * | K071519 | Hemcon Chitoflex-Surgical DressingSummary page 10…Unclassified III. Predicate Device(s): Predicate Devices: HemCon Bandage (K080818, K072486, K071519, K043050, K030946, K023298) Clo-Sur Pad (Plus) P.A.D. Scion Cardio-… | 2007 |
| * | K043050 | Hemcon Bandage and Hemcon Bandage OtcSummary page 10…Unclassified III. Predicate Device(s): Predicate Devices: HemCon Bandage (K080818, K072486, K071519, K043050, K030946, K023298) Clo-Sur Pad (Plus) P.A.D. Scion Cardio-… | 2005 |
| * | K030946 | Hemcon Bandage Otc; Hemcon Cath/AidSummary page 10…assified III. Predicate Device(s): Predicate Devices: HemCon Bandage (K080818, K072486, K071519, K043050, K030946, K023298) Clo-Sur Pad (Plus) P.A.D. Scion Cardio-… | 2003 |
| * | K023298 | Hemcon BandageSummary page 10…III. Predicate Device(s): Predicate Devices: HemCon Bandage (K080818, K072486, K071519, K043050, K030946, K023298) Clo-Sur Pad (Plus) P.A.D. Scion Cardio- Vascula… | 2002 |
| * | K112961 | Clo-Surplus P.a.D.Summary page 10…71519, K043050, K030946, K023298) Clo-Sur Pad (Plus) P.A.D. Scion Cardio- Vascular, Inc (K112961, K092552, K032986) The predicate devices have not been subject to a design related recall. HemCon Medical Technologies Inc.… | 2011 |
| * | K092552 | Clo-Surplus P.a.D.Summary page 10…43050, K030946, K023298) Clo-Sur Pad (Plus) P.A.D. Scion Cardio- Vascular, Inc (K112961, K092552, K032986) The predicate devices have not been subject to a design related recall. HemCon Medical Technologies Inc.… | 2009 |
| * | K032986 | Clo-Surplusp.a.D.Summary page 10…30946, K023298) Clo-Sur Pad (Plus) P.A.D. Scion Cardio- Vascular, Inc (K112961, K092552, K032986) The predicate devices have not been subject to a design related recall. HemCon Medical Technologies Inc.… | 2004 |
What descends from it? (3)
2 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 25 years and passes through 5 companies; a new generation was cleared every 2.5 years on median.
- 3 of the 46 ancestors have a recall of any class.
- Of its descendants, K182811 (Gel-E, Inc., 2019) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K080818.
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. 2015, 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® Bandage PRO is intended for local management of bleeding wounds and to provide a barrier to bacterial penetration of the dressing in all patients and for the promotion of rapid control (hemostasis) of bleeding in patients following hemodialysis and for those on anticoagulation therapy. The dressing is indicated for the following wounds: lacerations, abrasions, nose-bleeds, surgical debridement sites, skin surface puncture sites, vascular…
Read the full statement (397 words)
The HemCon® Bandage PRO is intended for local management of bleeding wounds and to provide a barrier to bacterial penetration of the dressing in all patients and for the promotion of rapid control (hemostasis) of bleeding in patients following hemodialysis and for those on anticoagulation therapy. The dressing is indicated for the following wounds: lacerations, abrasions, nose-bleeds, surgical debridement sites, skin surface puncture sites, vascular procedure sites and sites involving percutaneous catheters, tubes and pins
The HemCon® Patch PRO is intended for local management of bleeding wounds and to provide a barrier to bacterial penetration of the dressing in all patients and for the promotion of rapid control (hemostasis) of bleeding in patients following hemodialysis and for those on anticoagulation therapy. The dressing is indicated for the following wounds: lacerations, abrasions, nose-bleeds, surgical debridement sites, skin surface puncture sites, vascular procedure sites and sites involving percutaneous catheters, tubes and pins
The HemCon® Strip PRO is intended for local management of bleeding wounds and to provide a barrier to bacterial penetration of the dressing in all patients and for the promotion of rapid control (hemostasis) of bleeding in patients following hemodialysis and for those on anticoagulation therapy. The dressing is indicated for the following wounds: lacerations, abrasions, nose-bleeds, surgical debridement sites, skin surface puncture sites, vascular procedure sites and sites involving percutaneous catheters, tubes and pins
HemCon® ChitoFlex® PRO is intended for local management of bleeding wounds and to provide a barrier to bacterial penetration of the dressing in all patients and for the promotion of rapid control (hemostasis) of bleeding in patients following hemodialysis and for those on anticoagulation therapy. The dressing is indicated for the following wounds: lacerations, abrasions, nose-bleeds, surgical debridement sites, skin surface puncture sites, vascular procedure sites and sites involving percutaneous catheters, tubes and pins
The HemCon® Bandage OTC is indicated for the local management of bleeding wounds such as minor cuts, minor lacerations and minor abrasions and in patients on anticoagulation therapy. The HemCon Bandage OTC also provides an antibacterial barrier against a wide range of gram positive and gram negative organisms
The HemCon® Strip First Aid PRO is indicated for the local management of bleeding wounds such as minor cuts, minor lacerations and minor abrasions and in patients on anticoagulation therapy. The HemCon Bandage OTC also provides an antibacterial barrier against a wide range of gram positive and gram negative organisms.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150916 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150916: HemCon Bandage PRO, HemCon Patch PRO, HemCon Strip PRO, HemCon Strip First Aid PRO, ChitoFlex PRO.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150916
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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