510(k) · Cleared
ClearedHemaderm Cotaining Hemadex Clotting Beads
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medafor, Inc. · QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Cleared on Jul 12, 2002 after a 52-day review. The FDA summary names its predicate without a number. 46 later devices descend from it.
- Decided
- Jul 12, 2002
- Review
- 52 days
- Class
- Class U
- Product code
- QSY
- Recalls
- None
- Predicates
- 0
46 later devices descend from it, 5 citing it directly.
- This deviceK021678 Hemaderm Cotaining Hemadex Clotting BeadsMedafor, Inc. · 2002
- Descendant · cites it directly · 29 of its ownK033666 HemadermMedafor, Inc. · 2003
- Descendant · 2 generations on · 28 of its ownK070211 Traumarrest and Bleedarrest Hemostatic Particles and FoamHemostasis, LLC · 2007
- Descendant · 3 generations on · 19 of its ownK072900 Excelarrest FoamHemostasis, LLC · 2007
- Descendant · cites it directly · 16 of its ownK080210 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
Showing 5 of 46 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 46 · See all- K033666HemadermMedafor, Inc. · 2003 · cites it directly29descendants
- K070211Traumarrest and Bleedarrest Hemostatic Particles and FoamHemostasis, LLC · 2007 · 2 generations on28descendants
- K072900Excelarrest FoamHemostasis, LLC · 2007 · 3 generations on19descendants
- 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 · cites it directly13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K021678 | Hemaderm Cotaining Hemadex Clotting Beads | Medafor, Inc. | 2002 | — |
| +1 | K033666 | Hemaderm | Medafor, Inc. | 2003 | — |
| +2 | K070211 | Traumarrest and Bleedarrest Hemostatic Particles and Foam | Hemostasis, LLC | 2007 | — |
| +3 | K072900 | Excelarrest Foam | Hemostasis, LLC | 2007 | — |
| +1 | 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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 3 | 0 |
| 2014 | 6 | 0 |
| 2015 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 4 | 0 |
| 2019 | 4 | 0 |
| 2021 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 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? (9)
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 |
|---|---|---|---|
| * | — | Calgon Vestal Labs, Kaltostat Wound Dressing Named without a submission number | |
| * | — | Hemostace, Sorbastace Named without a submission number | |
| * | — | Kendall Hydrophylic Powder Wound Dressing Named without a submission number | |
| * | — | Marine Polymer Technology Healtec and Syvek Patch Named without a submission number | |
| * | — | Dennaphylyx Calcium Alginate Wound Dressing Named without a submission number | |
| * | — | Closure Medical, Liquiderm Liquid Bandage Named without a submission number | |
| * | — | Marine Polymer Technology RDH Bandage Named without a submission number | |
| * | — | Vascular Solutions, Duett Flowable Hemostat Named without a submission number | |
| * | — | Hospal Tipstop Compression Dressing Named without a submission number |
What descends from it? (46)
See all 465 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?
- Of its descendants, K033666 (Medafor, Inc., 2003) has gone furthest, with 29 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.
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?
HemaDerm™ is intended for use under the care of a health care professional as a topical dressing for the temporary treatment of severely bleeding wounds such as surgical wounds (post-operative, donor sites, dermatological), minor cuts and lacerations.
HemaDerm™ is intended for use under the care of a health care professional for the local management and control of bleeding from percutaneous needle access, vascular access sites and percutaneous catheters.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021678 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021678: Hemaderm Cotaining Hemadex Clotting Beads.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021678
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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