510(k) · Cleared
ClearedHemaderm
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 Dec 17, 2003 as substantially equivalent to K021678 (Medafor, Inc., 2002) and 10 other predicates after a 26-day review. Its family tree reaches back 3 generations to 1982. 29 later devices descend from it.
- Decided
- Dec 17, 2003
- Review
- 26 days
- Class
- Class U
- Product code
- QSY
- Recalls
- None
- Predicates
- 11
Its longest line of descent runs back 3 generations to K821150 (1982). 20 ancestors in all. 29 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK821150 NU-Gauze SpongeJohnson & Johnson Professionals, Inc. · 1982
- 2 generations backK984069 Entaxis Nasal PackingLes Laboratorires Brothier, S.A. · 1999
- 1 generation backK993362 HylasineBiomatrix, Inc. · 2000
- This deviceK033666 HemadermMedafor, Inc. · 2003
- Descendant · cites it directly · 28 of its ownK070211 Traumarrest and Bleedarrest Hemostatic Particles and FoamHemostasis, LLC · 2007
- Descendant · 2 generations on · 19 of its ownK072900 Excelarrest FoamHemostasis, LLC · 2007
- Descendant · cites it directly · 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
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 29 · See all- K070211Traumarrest and Bleedarrest Hemostatic Particles and FoamHemostasis, LLC · 2007 · cites it directly28descendants
- K072900Excelarrest FoamHemostasis, LLC · 2007 · 2 generations on19descendants
- K080818Hemcon Bandage, Hemcon Bandage Otc, Hemcon Chitoflex-Surgical DressingHem Con Medical Technologies, Inc. · 2008 · cites it directly11descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K821150 | NU-Gauze Sponge | Johnson & Johnson Professionals, Inc. | 1982 | — |
| −2 | K984069 | Entaxis Nasal Packing | Les Laboratorires Brothier, S.A. | 1999 | — |
| −1 | K993362 | Hylasine | Biomatrix, Inc. | 2000 | — |
| 0 (this device) | K033666 | Hemaderm | Medafor, Inc. | 2003 | — |
| +1 | K070211 | Traumarrest and Bleedarrest Hemostatic Particles and Foam | Hemostasis, LLC | 2007 | — |
| +2 | K072900 | Excelarrest Foam | Hemostasis, LLC | 2007 | — |
| +1 | 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 | — |
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 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 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 15.1 · 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? (13)
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 |
|---|---|---|---|
| * | K021678 | Hemaderm Cotaining Hemadex Clotting BeadsSummary page 6…ascular access sites and percutaneous catheters. 6. Substantial Equivalence The primary predicate for this submission is the original 510(k) notification for HemaDerm (K021678, cleared July 12, 2002). The product which is the subject of this notification i; identical to that product in the following resp… | 2002 |
| * | K002972 | Merogel Control Gel Ent Surgical DressingSummary page 7…g from percutaneous needle access, vascular access sites and percutaneous catheters. Xomed K002972 HYAFF, an ester of MeroGel Control Gel ENT Surgical Dressing is a dressing and/or stent intended to MeroGel ENT… | 2000 |
| * | K012532 | Sepragel SinusSummary page 7…gnus, and/or throat surgery where separation of tissues or structures is desired. Genzyme Hylasine KG012532 Derivative hyaluronic HylaSine is indicated for use in patients undergoing nasal/sinus surgery as a space- (Sepragel Sinus… | 2001 |
| * | K984388 | HA Absorbent Wound DressingSummary page 7…on, or it may aspirated form the cavity earlier at the discretion of the physician. Convatec HA K984388 HYAFF I1p75, a HA Absorbent Wound Dressing.R is indicated for use inthe management of deep exuding Absorbent Wound… | 1999 |
| * | K030334 | T-Scientific T-PadSummary page 7…ng Absorbent Wound benzyl ester of wounds, sinuses, and fistulae DressingR hyaluronic acid T Scientific T-Pad K030334 poly-N-acetyl The T-Scientific T-Pad isintended for use in the local management of bleeding wounds… | 2003 |
| * | K984177 | Modification to SkvekpatchSummary page 7…lt and For nosebleeds (only in the anterior nasal cavity) and hard to treat areas QR Powder exempt hydrophilic polymers Marine Polymers K984177 Polysaccharide/poly- ProDein Patch is indicted for use in the local management of bleeding wounds such as ProDein Patch… | 1998 |
| * | K984069 | Entaxis Nasal PackingSummary page 7…local management of bleeding wounds such as ProDein Patch n-acetyl glucosamine lacerations, abrasions, and nosebleeds. Les Laboratoires K984069 calcium alginate ENTaxis Nasal Packings are intended for nasal epistaxis and as post operative nasal Brothier S.A.… | 1999 |
| * | K830264 | Floret Tonsil & Adenoid SpongesSummary page 7…esigned with an Raypaque element inside, this sponge is x-ray detectable. Sterile. RITMED, Inc. Floet K830264 Gauze covered super- Gauze covered super-absorbent non-woven cotton. Available sterile. Available double Tonsil and Aden… | 1983 |
| * | K000108 | Rapid Rhino-Anterior 90MM, Model RR-a 90, Rapid Rhino-Posterior 100MM, Model RR-P 100Summary page 7…", 1 '4 Sponges cotton "double strung and ':" x I", V2"x V/2", W 'stungon count card Applied K000108 PVC catheter with Rapid Rhno is designed to control epistaxis due to: Therapeutics, Inc. carboxy-… | 2000 |
| * | K972459 | Rhinocell Nasal PackingsSummary page 7…Controls minor bleeding via active platelet aggregation, when exposed to blood or fluids. Boston Medical K972459 Lint and fiber free For use as a nasal packing to treat epistaxis. Products Rhinocell polyvinyl alcoho… | 1997 |
| * | K993362 | HylasineSummary page 7…polyvinyl alcohol Superior liquid absorption and wicking characteristics Nasal Packings sponge material BIOMATRIX,Inc. K993362 Sterile, transparent, The intended use of Hylasone is for use in nasal/sinus cavity as a spac-occupying gel Hylasine… | 2000 |
| * | — | BioLife NoseBleed QR Powder Named without a submission number | |
| * | — | Single and Double Strung Tonsil Sponges and Double Strung Cylindrical Sponges Named without a submission number |
What descends from it? (29)
See all 294 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070211 | Traumarrest and Bleedarrest Hemostatic Particles and Foam | 2007 | 28 |
| K080818 | Hemcon Bandage, Hemcon Bandage Otc, Hemcon Chitoflex-Surgical Dressing | 2008 | 11 |
| K102459 | Nexstat (TM) Topical Hemostat Powder; Nexfoam (R) Topical Sponge | 2010 | 9 |
| K122886 | Nexstat Plus and Nexfoam Plus Topical Hemostat Dressing | 2012 | 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 21 years and passes through 4 companies; a new generation was cleared every 3.8 years on median.
- None of the 20 ancestors has a recall.
- Of its descendants, K070211 (Hemostasis, LLC, 2007) has gone furthest, with 28 descendants of its own.
- 4 other devices also cite its predicate K021678.
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?
HemaDermTM 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 and for the temporary treatment of mild bleeding from topical ENT surgical wounds and nosebleeds.
HemaDermTM 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/K033666 · printed Nov 3, 2026
Cite this page
510(k) Report. “K033666: Hemaderm.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033666
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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