510(k) · Cleared
ClearedBiopad
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Euroresearch Srl · QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Cleared on Jul 22, 2005 as substantially equivalent to K990086 (Integra Lifesciences Corp., 1999) and 1 other predicate after a 532-day review. Its family tree reaches back 2 generations to 1988. 28 later devices descend from it.
- Decided
- Jul 22, 2005
- Review
- 532 days
- Class
- Class U
- Product code
- QSY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K881854 (1988). 5 ancestors in all. 28 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK881854 Sorbsan Topical Wound DressingE.G. Dick & Assoc. · 1988
- 1 generation backK982597 Fibrcol Plus Collagen Wound Dressing with AlginateJohnson & Johnson Medical, Inc. · 1998
- This deviceK040283 BiopadEuroresearch Srl · 2005
- Descendant · cites it directly · 26 of its ownK061494 Dermadapt Wound DressingPegasus Biologics, Inc. · 2006
- Descendant · 2 generations on · 25 of its ownK071425 Unite BiomatrixPegasus Biologics, Inc. · 2007
- Descendant · 3 generations on · 19 of its ownK092096 Endoform Dermal TemplateMesynthes, Ltd. · 2010 · Recalled
- Descendant · 3 generations on · 7 of its ownK082103 LTM Wound DressingLifecell Corp. · 2008
- Descendant · 4 generations on · 5 of its ownK132343 Marigen Wound DressingKerecis Limited · 2013
Showing 5 of 28 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 28 · See all- K061494Dermadapt Wound DressingPegasus Biologics, Inc. · 2006 · cites it directly26descendants
- K071425Unite BiomatrixPegasus Biologics, Inc. · 2007 · 2 generations on25descendants
- K092096Endoform Dermal TemplateMesynthes, Ltd. · 2010 · 3 generations on19descendants
- K082103LTM Wound DressingLifecell Corp. · 2008 · 3 generations on7descendants
- K132343Marigen Wound DressingKerecis Limited · 2013 · 4 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K881854 | Sorbsan Topical Wound Dressing | E.G. Dick & Assoc. | 1988 | — |
| −1 | K982597 | Fibrcol Plus Collagen Wound Dressing with Alginate | Johnson & Johnson Medical, Inc. | 1998 | — |
| 0 (this device) | K040283 | Biopad | Euroresearch Srl | 2005 | — |
| +1 | K061494 | Dermadapt Wound Dressing | Pegasus Biologics, Inc. | 2006 | — |
| +2 | K071425 | Unite Biomatrix | Pegasus Biologics, Inc. | 2007 | — |
| +3 | K092096 | Endoform Dermal Template | Mesynthes, Ltd. | 2010 | 3 |
| +3 | K082103 | LTM Wound Dressing | Lifecell Corp. | 2008 | — |
| +4 | K132343 | Marigen Wound Dressing | Kerecis Limited | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 3 | 0 |
| 2026 | 4 | 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K990086 | Heliderm Collagen Wound Dressings 0.5 Gram and 1.0 GramSummary page 5…nt of bleedings and wounds, i.e.: PREDICATE DEVICE 510(K) MANUFACTURER HeliDerm collagen wound dressing K990086 Integra LifeScience Corporation Fibracol Plus colla… | 1999 |
| * | K982597 | Fibrcol Plus Collagen Wound Dressing with AlginateSummary page 5…K990086 Integra LifeScience Corporation Fibracol Plus collagen wound dressing with K982597 Johnson & Johnson Medical alginate SIS Wound Dressing H K993490 Cook Biotech In… | 1998 |
| Kept off the family tree | K993490 | FDA’s K993490 is Quickstrip One Step Opiates Test Our reading of the summary gave K993490, FDA’s number for Quickstrip One Step Opiates Test (Syntron Bioresearch, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “SIS Wound Dressing H”. Kept off the family tree. Summary page 5…Corporation Fibracol Plus collagen wound dressing with K982597 Johnson & Johnson Medical alginate SIS Wound Dressing H K993490 Cook Biotech Inc. EURORESEARCHEL BIOPAD® TRADITIONAL 510(K) PREMARKET NOTIFICATION-SUMMARY DEVICE DESC… | 1999 |
What descends from it? (28)
See all 282 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 17 years and passes through 3 companies; a new generation was cleared every 10.1 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K061494 (Pegasus Biologics, Inc., 2006) has gone furthest, with 26 descendants of its own.
- 7 other devices also cite its predicate K990086.
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?
BIOPAD® is a collagen wound dressing intended for the control of minor bleeding, and for the local management of moderately to heavy exuding wounds including:
pressure ulcers,
venous stasis ulcers,
diabetic ulcers,
partial and full thickness wounds,
surgical and traumatic wounds,
donor sites and other bleeding surface wounds
dehisced surgical incisions
draining wounds
lacerations
podiatric
post-laser surgery
The product is supplied sterile and for one-time-use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040283 · printed Nov 3, 2026
Cite this page
510(k) Report. “K040283: Biopad.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K040283
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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