510(k) · Cleared
ClearedTraumarrest and Bleedarrest Hemostatic Particles and 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 Apr 5, 2007 as substantially equivalent to K033666 (Medafor, Inc., 2003) and 1 other predicate after a 73-day review. Its family tree reaches back 4 generations to 1982. 28 later devices descend from it.
- Decided
- Apr 5, 2007
- Review
- 73 days
- Class
- Class U
- Product code
- QSY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K821150 (1982). 22 ancestors in all. 28 later devices descend from it, 5 citing it directly.
- Root · 4 generations backK821150 NU-Gauze SpongeJohnson & Johnson Professionals, Inc. · 1982
- 3 generations backK984069 Entaxis Nasal PackingLes Laboratorires Brothier, S.A. · 1999
- 2 generations backK993362 HylasineBiomatrix, Inc. · 2000
- 1 generation backK033666 HemadermMedafor, Inc. · 2003
- This deviceK070211 Traumarrest and Bleedarrest Hemostatic Particles and FoamHemostasis, LLC · 2007
- Descendant · cites it directly · 19 of its ownK072900 Excelarrest FoamHemostasis, LLC · 2007
- Descendant · 2 generations on · 11 of its ownK080818 Hemcon Bandage, Hemcon Bandage Otc, Hemcon Chitoflex-Surgical DressingHem Con Medical Technologies, Inc. · 2008
- Descendant · cites it directly · 9 of its ownK102459 Nexstat (TM) Topical Hemostat Powder; Nexfoam (R) Topical SpongeHemostasis, LLC · 2010
- Descendant · 2 generations on · 6 of its ownK120958 Posisep and Posisep X Hemostat DressingsHemostasis, LLC · 2012
- Descendant · 3 generations on · 5 of its ownK090620 Quikclot Inteventional, Model P/N 182Z-Medica Corporation · 2009
Showing 5 of 28 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 28 · See all- K072900Excelarrest FoamHemostasis, LLC · 2007 · cites it directly19descendants
- K080818Hemcon Bandage, Hemcon Bandage Otc, Hemcon Chitoflex-Surgical DressingHem Con Medical Technologies, Inc. · 2008 · 2 generations on11descendants
- K102459Nexstat (TM) Topical Hemostat Powder; Nexfoam (R) Topical SpongeHemostasis, LLC · 2010 · cites it directly9descendants
- K120958Posisep and Posisep X Hemostat DressingsHemostasis, LLC · 2012 · 2 generations on6descendants
- K090620Quikclot Inteventional, Model P/N 182Z-Medica Corporation · 2009 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K821150 | NU-Gauze Sponge | Johnson & Johnson Professionals, Inc. | 1982 | — |
| −3 | K984069 | Entaxis Nasal Packing | Les Laboratorires Brothier, S.A. | 1999 | — |
| −2 | K993362 | Hylasine | Biomatrix, Inc. | 2000 | — |
| −1 | K033666 | Hemaderm | Medafor, Inc. | 2003 | — |
| 0 (this device) | K070211 | Traumarrest and Bleedarrest Hemostatic Particles and Foam | Hemostasis, LLC | 2007 | — |
| +1 | K072900 | Excelarrest Foam | Hemostasis, LLC | 2007 | — |
| +2 | K080818 | Hemcon Bandage, Hemcon Bandage Otc, Hemcon Chitoflex-Surgical Dressing | Hem Con Medical Technologies, Inc. | 2008 | — |
| +1 | K102459 | Nexstat (TM) Topical Hemostat Powder; Nexfoam (R) Topical Sponge | Hemostasis, LLC | 2010 | — |
| +2 | K120958 | Posisep and Posisep X Hemostat Dressings | Hemostasis, LLC | 2012 | — |
| +3 | K090620 | Quikclot Inteventional, Model P/N 182 | Z-Medica Corporation | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1997 | 4 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 4 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K033666 | HemadermSummary page 5…tTM and BleedArrest particles and foam are substantially equivalent to the Medafor HemaDerm and Bleed-X products which were the subject of premarket notification numbers K033666 and K013225. Hemostasis, LLC believes we have demonstrated that our hemostat devices have performed as well as the above predicat… | 2003 |
| * | K013225 | Instaclot for Otc Use, Traumasstat for Prescription UseSummary page 5…dArrest particles and foam are substantially equivalent to the Medafor HemaDerm and Bleed-X products which were the subject of premarket notification numbers K033666 and K013225. Hemostasis, LLC believes we have demonstrated that our hemostat devices have performed as well as the above predicate devices. A… | 2001 |
What descends from it? (28)
See all 285 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 3.8 years on median.
- None of the 22 ancestors has a recall.
- Of its descendants, K072900 (Hemostasis, LLC, 2007) has gone furthest, with 19 descendants of its own.
- 3 other devices also cite its predicate K033666.
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: TraumArrest MT 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: BleedArrestTM particles and foam are 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/K070211 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070211: Traumarrest and Bleedarrest Hemostatic Particles and Foam.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070211
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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