510(k) · Cleared
ClearedExcelarrest Foam
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hemostasis, LLC · QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Cleared on Oct 26, 2007 as substantially equivalent to K070211 (Hemostasis, LLC, 2007) and 1 other predicate after a 15-day review. Its family tree reaches back 5 generations to 1990. 19 later devices descend from it.
- Decided
- Oct 26, 2007
- Review
- 15 days
- Class
- Class U
- Product code
- QSY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K896068 (1990). 28 ancestors in all, the oldest K821150 (1982). 19 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK896068 Tipstop (TM)Gambro-Hospal, Inc. · 1990
- 4 generations backK982818 Hospal TipstopGambro Healthcare · 1998
- 3 generations backK012293 Vascular Solutions Duett Flowable HemostatVascular Solutions, Inc. · 2002
- 2 generations backK030836 D-Stat-Dry Hemostatic Bandage; D-Stat Radial Hemostatic BandageVascular Solutions, Inc. · 2003 · Recalled
- 1 generation backK050511 Thrombigel Thrombin/Gelatin Foam HemostatVascular Solutions, Inc. · 2005
- This deviceK072900 Excelarrest FoamHemostasis, LLC · 2007
- Descendant · cites it directly · 11 of its ownK080818 Hemcon Bandage, Hemcon Bandage Otc, Hemcon Chitoflex-Surgical DressingHem Con Medical Technologies, Inc. · 2008
- Descendant · cites it directly · 6 of its ownK120958 Posisep and Posisep X Hemostat DressingsHemostasis, LLC · 2012
- Descendant · 2 generations on · 5 of its ownK090620 Quikclot Inteventional, Model P/N 182Z-Medica Corporation · 2009
- Descendant · 2 generations on · 3 of its ownK150916 HemCon Bandage PRO, HemCon Patch PRO, HemCon Strip PRO, HemCon Strip…Hem Con Medical Technologies, Inc. · 2015
- Descendant · 2 generations on · 2 of its ownK141704 Novashield Injectable Nasal Packing and StentMedtronic, Inc. · 2014
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K080818Hemcon Bandage, Hemcon Bandage Otc, Hemcon Chitoflex-Surgical DressingHem Con Medical Technologies, Inc. · 2008 · cites it directly11descendants
- K120958Posisep and Posisep X Hemostat DressingsHemostasis, LLC · 2012 · cites it directly6descendants
- K090620Quikclot Inteventional, Model P/N 182Z-Medica Corporation · 2009 · 2 generations on5descendants
- K150916HemCon Bandage PRO, HemCon Patch PRO, HemCon Strip PRO, HemCon Strip First Aid PRO…Hem Con Medical Technologies, Inc. · 2015 · 2 generations on3descendants
- K141704Novashield Injectable Nasal Packing and StentMedtronic, Inc. · 2014 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K896068 | Tipstop (TM) | Gambro-Hospal, Inc. | 1990 | — |
| −4 | K982818 | Hospal Tipstop | Gambro Healthcare | 1998 | — |
| −3 | K012293 | Vascular Solutions Duett Flowable Hemostat | Vascular Solutions, Inc. | 2002 | — |
| −2 | K030836 | D-Stat-Dry Hemostatic Bandage; D-Stat Radial Hemostatic Bandage | Vascular Solutions, Inc. | 2003 | 3 |
| −1 | K050511 | Thrombigel Thrombin/Gelatin Foam Hemostat | Vascular Solutions, Inc. | 2005 | — |
| 0 (this device) | K072900 | Excelarrest Foam | Hemostasis, LLC | 2007 | — |
| +1 | K080818 | Hemcon Bandage, Hemcon Bandage Otc, Hemcon Chitoflex-Surgical Dressing | Hem Con Medical Technologies, Inc. | 2008 | — |
| +1 | K120958 | Posisep and Posisep X Hemostat Dressings | Hemostasis, LLC | 2012 | — |
| +2 | K090620 | Quikclot Inteventional, Model P/N 182 | Z-Medica Corporation | 2009 | — |
| +2 | K150916 | HemCon Bandage PRO, HemCon Patch PRO, HemCon Strip PRO, HemCon Strip First Aid… | Hem Con Medical Technologies, Inc. | 2015 | — |
| +2 | K141704 | Novashield Injectable Nasal Packing and Stent | Medtronic, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1983 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1997 | 4 | 0 |
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2000 | 3 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 3 | 0 |
| 2021 | 1 | 0 |
| 2023 | 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? (3)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K070211 | Traumarrest and Bleedarrest Hemostatic Particles and FoamSummary page 5…Equivalence: The Hemostasis, LLC ExcelArrestTM foam hemostat is Substantially Equivalent to the Hemostasis, LLC products that were the subject of premarket notification K070211, the Hemcon bandage which was subject of premarket notification K0303946 and the Vascular Solutions bandage which was subject of… | 2007 |
| Kept off the family tree | K030394 | FDA’s K030394 is Fluid Sample Retrieval System Our reading of the summary gave K030394, FDA’s number for Fluid Sample Retrieval System (Biomed Personal Metabolic and Nutritional Testing). Its FDA name has none of the distinctive words the summary uses for the device it names, “Hemcon bandage”. Kept off the family tree. Summary page 5…tially Equivalent to the Hemostasis, LLC products that were the subject of premarket notification K070211, the Hemcon bandage which was subject of premarket notification K0303946 and the Vascular Solutions bandage which was subject of premarket notification K05051 1. DESCRIPTION As described above, the He… | 2003 |
| * | K050511 | Thrombigel Thrombin/Gelatin Foam HemostatSummary page 5…ification K070211, the Hemcon bandage which was subject of premarket notification K0303946 and the Vascular Solutions bandage which was subject of premarket notification K05051 1. DESCRIPTION As described above, the Hemostasis, LLC hemostats are comprised of modified chitin particles and polysaccharide bin… | 2005 |
What descends from it? (19)
See all 192 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 17 years and passes through 4 companies; a new generation was cleared every 2.5 years on median.
- 1 of the 28 ancestors has a recall of any class.
- Of its descendants, K080818 (Hem Con Medical Technologies, Inc., 2008) has gone furthest, with 11 descendants of its own.
- 4 other devices also cite its predicate K070211.
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. 2007, 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 Hemostasis, LLC wound dressings are intended for use as topical dressings for the management of bleeding wounds.
Prescription: ExcelArrestM is indicated for use as a topical dressing for the temporary treatment of moderate to severely bleeding wounds such as surgical wounds (post-operative, donor sites, dermatological), cuts and lacerations and is also indicated for control of bleeding from the skin at percutaneous needle access, vascular access and percutaneous catheter access sites.
OTC: ExcelArrestTM is indicated for use as a topical dressing on minor bleeding wounds such as cuts, lacerations and abrasions and for minor nose bleeds.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072900 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072900: Excelarrest Foam.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072900
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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