510(k) · Cleared
ClearedPro QR Advanced Formula Powder
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 Feb 10, 2009 as substantially equivalent to K070520 (Biolife, LLC, 2007) and 2 other predicates after a 379-day review. Its family tree reaches back 2 generations to 2000. 16 later devices descend from it.
- Decided
- Feb 10, 2009
- Review
- 379 days
- Class
- Class U
- Product code
- QSY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K002550 (2000). 5 ancestors in all, the oldest K965034 (1998). 16 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK002550 RDH BandageMarine Polymer Technologies, Inc. · 2000
- 1 generation backK013390 QuickclotOn Site Gas Systems, Inc. · 2002
- This deviceK080210 Pro QR Advanced Formula PowderBiolife, LLC · 2009
- Descendant · cites it directly · 13 of its ownK093593 Celox Pro, Celox Pro Otc, Celox Hemostatic Granules, Celox Pro…Medtrade Products Limited · 2010
- Descendant · 2 generations on · 11 of its ownK113560 Celox Gauze ProMedtrade Products, Ltd. · 2012
- Descendant · 3 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 · 2 generations on · 2 of its ownK240713 Traumagel®Cresilon, Inc. · 2024
- Descendant · 3 generations on · 2 of its ownK143462 AnsCare ChitoClot Gauze (prescription use), AnsCare ChitoClot Gauze…Benq Materials Corporation · 2015
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K093593Celox Pro, Celox Pro Otc, Celox Hemostatic Granules, Celox Pro Hemostatic Granules, Omni…Medtrade Products Limited · 2010 · cites it directly13descendants
- K113560Celox Gauze ProMedtrade Products, Ltd. · 2012 · 2 generations on11descendants
- K133121Chito-Sam 100,4IN X4IN,Chito-Sam, 3IN X6FT, Chito-Sam 100,3IN X10FT, Chito-Sam Active…Sam Medical Products · 2014 · 3 generations on5descendants
- K240713Traumagel®Cresilon, Inc. · 2024 · 2 generations on2descendants
- K143462AnsCare ChitoClot Gauze (prescription use), AnsCare ChitoClot Gauze (over-the-counter use)Benq Materials Corporation · 2015 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K002550 | RDH Bandage | Marine Polymer Technologies, Inc. | 2000 | — |
| −1 | K013390 | Quickclot | On Site Gas Systems, Inc. | 2002 | — |
| 0 (this device) | K080210 | Pro QR Advanced Formula Powder | Biolife, LLC | 2009 | — |
| +1 | K093593 | Celox Pro, Celox Pro Otc, Celox Hemostatic Granules, Celox Pro Hemostatic… | Medtrade Products Limited | 2010 | — |
| +2 | K113560 | Celox Gauze Pro | Medtrade Products, Ltd. | 2012 | — |
| +3 | K133121 | Chito-Sam 100,4IN X4IN,Chito-Sam, 3IN X6FT, Chito-Sam 100,3IN X10FT, Chito-Sam… | Sam Medical Products | 2014 | — |
| +2 | K240713 | Traumagel® | Cresilon, Inc. | 2024 | — |
| +3 | K143462 | AnsCare ChitoClot Gauze (prescription use), AnsCare ChitoClot Gauze… | Benq Materials Corporation | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K070520 | Pro QR (Quick Relief) Powder (for Minor External Bleeding From Wounds & Procedures)Summary page 5…Dressing Classification Name: Dressing, Unclassified 5.4 Predicate Device Biolife, L. L.C.; PRO OR (Quick Relief)®0 Powder (K070520) Medafor, Inc.; HemaDerm (K021678) On Site Gas Systems, Inc.; QuikClot (K013390) Biolife, L.L.C. 1235 Ta… | 2007 |
| * | K021678 | Hemaderm Cotaining Hemadex Clotting BeadsSummary page 5…Dressing, Unclassified 5.4 Predicate Device Biolife, L. L.C.; PRO OR (Quick Relief)®0 Powder (K070520) Medafor, Inc.; HemaDerm (K021678) On Site Gas Systems, Inc.; QuikClot (K013390) Biolife, L.L.C. 1235 Tallevast Road, Sarasota, FL 34243… | 2002 |
| * | K013390 | QuickclotSummary page 5…e Device Biolife, L. L.C.; PRO OR (Quick Relief)®0 Powder (K070520) Medafor, Inc.; HemaDerm (K021678) On Site Gas Systems, Inc.; QuikClot (K013390) Biolife, L.L.C. 1235 Tallevast Road, Sarasota, FL 34243 5-2… | 2002 |
What descends from it? (16)
See all 162 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 9 years and passes through 3 companies; a new generation was cleared every 6.7 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K093593 (Medtrade Products Limited, 2010) has gone furthest, with 13 descendants of its own.
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. 2009, 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 for minor external bleeding from wounds and procedures is intended for use as a topical dressing for bleeding control associated with minor wounds, including control of minor external bleeding and exudate from sutures and/or surgical procedures.
PRO QR Powder for moderate to severe external bleeding wounds is intended for emergency use of temporary external treatment for controlling moderate to severe bleeding.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080210 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080210: Pro QR Advanced Formula Powder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080210
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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