510(k) · Cleared
ClearedPro QR (Quick Relief) Powder (for Minor External Bleeding From Wounds & Procedures)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biolife, LLC · QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Cleared on Oct 23, 2007 as substantially equivalent to K965034 (Hemostace, LLC, 1998) after a 242-day review. Its family tree reaches back 1 generation to 1998. 17 later devices descend from it.
- Decided
- Oct 23, 2007
- Review
- 242 days
- Class
- Class U
- Product code
- QSY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K965034 (1998). 17 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK965034 SorbastaceHemostace, LLC · 1998
- This deviceK070520 Pro QR (Quick Relief) Powder (for Minor External Bleeding From…Biolife, LLC · 2007
- Descendant · cites it directly · 16 of its ownK080210 Pro QR Advanced Formula PowderBiolife, LLC · 2009
- Descendant · 2 generations on · 13 of its ownK093593 Celox Pro, Celox Pro Otc, Celox Hemostatic Granules, Celox Pro…Medtrade Products Limited · 2010
- Descendant · 3 generations on · 11 of its ownK113560 Celox Gauze ProMedtrade Products, Ltd. · 2012
- Descendant · 4 generations on · 5 of its ownK133121 Chito-Sam 100,4IN X4IN,Chito-Sam, 3IN X6FT, Chito-Sam 100,3IN X10FT…Sam Medical Products · 2014
- Descendant · 3 generations on · 2 of its ownK240713 Traumagel®Cresilon, Inc. · 2024
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K080210Pro QR Advanced Formula PowderBiolife, LLC · 2009 · cites it directly16descendants
- K093593Celox Pro, Celox Pro Otc, Celox Hemostatic Granules, Celox Pro Hemostatic Granules, Omni…Medtrade Products Limited · 2010 · 2 generations on13descendants
- K113560Celox Gauze ProMedtrade Products, Ltd. · 2012 · 3 generations on11descendants
- K133121Chito-Sam 100,4IN X4IN,Chito-Sam, 3IN X6FT, Chito-Sam 100,3IN X10FT, Chito-Sam Active…Sam Medical Products · 2014 · 4 generations on5descendants
- K240713Traumagel®Cresilon, Inc. · 2024 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K965034 | Sorbastace | Hemostace, LLC | 1998 | — |
| 0 (this device) | K070520 | Pro QR (Quick Relief) Powder (for Minor External Bleeding From Wounds &… | Biolife, LLC | 2007 | — |
| +1 | K080210 | Pro QR Advanced Formula Powder | Biolife, LLC | 2009 | — |
| +2 | K093593 | Celox Pro, Celox Pro Otc, Celox Hemostatic Granules, Celox Pro Hemostatic… | Medtrade Products Limited | 2010 | — |
| +3 | K113560 | Celox Gauze Pro | Medtrade Products, Ltd. | 2012 | — |
| +4 | K133121 | Chito-Sam 100,4IN X4IN,Chito-Sam, 3IN X6FT, Chito-Sam 100,3IN X10FT, Chito-Sam… | Sam Medical Products | 2014 | — |
| +3 | K240713 | Traumagel® | Cresilon, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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? (1)
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 |
|---|---|---|---|
| * | K965034 | SorbastaceSummary page 5…Powder Wound Dressing Classification Name: Dressing, Unclassified 5.4 Predicate Device Hemostace, LLC; Sorbastace (K965034) Biolife, L.L.C. 1235 Tallevast Road, Sarasota, FL 34243 5-2… | 1998 |
What descends from it? (17)
See all 171 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K080210 | Pro QR Advanced Formula Powder | 2009 | 16 |
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?
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?
PRO QR Powder is intended for use to stop minor bleeding and to absorb body fluid in traumatic superficial lacerations or wounds. Once exudation and bleeding have stopped, a protective dressing can be applied. It is intended to be distributed as a Professional Use (Non-Prescription) Device.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K070520 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070520: Pro QR (Quick Relief) Powder (for Minor External Bleeding From Wounds & Procedures).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070520
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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