510(k) · Cleared
ClearedStopsbleeding Topical Hemostat Powder and Foam
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Coag Medical, LLC · QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Cleared on Jul 28, 2014 as substantially equivalent to K070211 (Hemostasis, LLC, 2007) and 1 other predicate after a 168-day review. Its family tree reaches back 5 generations to 1982. 1 later device descends from it.
- Decided
- Jul 28, 2014
- Review
- 168 days
- Class
- Class U
- Product code
- QSY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K821150 (1982). 23 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK821150 NU-Gauze SpongeJohnson & Johnson Professionals, Inc. · 1982
- 4 generations backK984069 Entaxis Nasal PackingLes Laboratorires Brothier, S.A. · 1999
- 3 generations backK993362 HylasineBiomatrix, Inc. · 2000
- 2 generations backK033666 HemadermMedafor, Inc. · 2003
- 1 generation backK070211 Traumarrest and Bleedarrest Hemostatic Particles and FoamHemostasis, LLC · 2007
- This deviceK140313 Stopsbleeding Topical Hemostat Powder and FoamCoag Medical, LLC · 2014
- Descendant · cites it directly · 0 of its ownK240097 Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5)Ushare Medical, Inc. · 2024
Most influential descendants
Showing 1 of 1 · See all- K240097Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5)Ushare Medical, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K821150 | NU-Gauze Sponge | Johnson & Johnson Professionals, Inc. | 1982 | — |
| −4 | K984069 | Entaxis Nasal Packing | Les Laboratorires Brothier, S.A. | 1999 | — |
| −3 | K993362 | Hylasine | Biomatrix, Inc. | 2000 | — |
| −2 | K033666 | Hemaderm | Medafor, Inc. | 2003 | — |
| −1 | K070211 | Traumarrest and Bleedarrest Hemostatic Particles and Foam | Hemostasis, LLC | 2007 | — |
| 0 (this device) | K140313 | Stopsbleeding Topical Hemostat Powder and Foam | Coag Medical, LLC | 2014 | — |
| +1 | K240097 | Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5) | Ushare Medical, Inc. | 2024 | — |
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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K070211 | Traumarrest and Bleedarrest Hemostatic Particles and FoamSummary page 6…icate devices: Manufacturer Brand Name 510(k) Number Hemostasis, LLC TraumArrest®/BleedArrest® K070211 Medafor Bleed-X™/Traumadex™ K013225 StopsBleeding™ Topical Hemostat Powder and Foam ar… | 2007 |
| * | K013225 | Instaclot for Otc Use, Traumasstat for Prescription UseSummary page 6…510(k) Number Hemostasis, LLC TraumArrest®/BleedArrest® K070211 Medafor Bleed-X™/Traumadex™ K013225 StopsBleeding™ Topical Hemostat Powder and Foam are technically identical hemostats as the predicates and have the same intended… | 2001 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K240097 | Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5) | 2024 | 0 |
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 32 years and passes through 6 companies; a new generation was cleared every 3.8 years on median.
- None of the 23 ancestors has a recall.
- Of its descendants, K240097 (Ushare Medical, Inc., 2024) has gone furthest, with 0 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. 2014, 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 CoAg Medical, LLC StopsBleeding™ Topical Hemostat Powder and Foam are intended for use as a topical dressing for the management of bleeding wounds and are available for prescription use and over-the-counter use. Prescription: StopsBleeding™ Rx Topical Hemostat Powder and Foam are 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…
Read the full statement (137 words)
The CoAg Medical, LLC StopsBleeding™ Topical Hemostat Powder and Foam are
intended for use as a topical dressing for the management of bleeding wounds and are
available for prescription use and over-the-counter use.
Prescription: StopsBleeding™ Rx Topical Hemostat Powder and Foam are 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 are also indicated for control of bleeding from the skin at percutaneous
needle access, vascular access and percutaneous catheter access sites. StopsBleeding™
Rx is intended for use under the care of a health care professional.
OTC: StopsBleeding™ OTC Topical Hemostat Powder 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/K140313 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140313: Stopsbleeding Topical Hemostat Powder 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/K140313
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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