510(k) · Cleared
ClearedClo-Surplusp.a.D.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Scion Cardio-Vascular, Inc. · QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Cleared on Mar 1, 2004 as substantially equivalent to K024298 (Advanced Medical Solutions, Ltd., 2003) and 3 other predicates after a 159-day review. Its family tree reaches back 4 generations to 1991. 25 later devices descend from it.
- Decided
- Mar 1, 2004
- Review
- 159 days
- Class
- Class U
- Product code
- QSY
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K914575 (1991). 10 ancestors in all. 25 later devices descend from it, 7 citing it directly.
- Root · 4 generations backK914575 Sorbsan Topical Wound Dressing (Modified)Dow B. Hickam, Inc. · 1991
- 3 generations backK983210 Algisite MSmith & Nephew, Inc. · 1998
- 2 generations backK002896 Acticoat Foam Dressing, Algisite M Calcium Alginate DressingThe Westaim Corp. · 2001
- 1 generation backK024298 Antimicrobial Alginate DressingAdvanced Medical Solutions, Ltd. · 2003
- This deviceK032986 Clo-Surplusp.a.D.Scion Cardio-Vascular, Inc. · 2004
- 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 · 6 of its ownK070175 Aquanova Super-Absorbent Gelling Dressing, OtcMedtrade Products, Ltd. · 2007
- Descendant · 2 generations on · 5 of its ownK090620 Quikclot Inteventional, Model P/N 182Z-Medica Corporation · 2009
- Descendant · cites it directly · 3 of its ownK150916 HemCon Bandage PRO, HemCon Patch PRO, HemCon Strip PRO, HemCon Strip…Hem Con Medical Technologies, Inc. · 2015
- Descendant · 2 generations on · 2 of its ownK143124 KA01 Chitosan Wound DressingFoshan United Medical Technologies, Ltd. · 2015
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K080818Hemcon Bandage, Hemcon Bandage Otc, Hemcon Chitoflex-Surgical DressingHem Con Medical Technologies, Inc. · 2008 · cites it directly11descendants
- K070175Aquanova Super-Absorbent Gelling Dressing, OtcMedtrade Products, Ltd. · 2007 · cites it directly6descendants
- K090620Quikclot Inteventional, Model P/N 182Z-Medica Corporation · 2009 · 2 generations on5descendants
- K150916HemCon Bandage PRO, HemCon Patch PRO, HemCon Strip PRO, HemCon Strip First Aid PRO…Hem Con Medical Technologies, Inc. · 2015 · cites it directly3descendants
- K143124KA01 Chitosan Wound DressingFoshan United Medical Technologies, Ltd. · 2015 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K914575 | Sorbsan Topical Wound Dressing (Modified) | Dow B. Hickam, Inc. | 1991 | — |
| −3 | K983210 | Algisite M | Smith & Nephew, Inc. | 1998 | — |
| −2 | K002896 | Acticoat Foam Dressing, Algisite M Calcium Alginate Dressing | The Westaim Corp. | 2001 | — |
| −1 | K024298 | Antimicrobial Alginate Dressing | Advanced Medical Solutions, Ltd. | 2003 | — |
| 0 (this device) | K032986 | Clo-Surplusp.a.D. | Scion Cardio-Vascular, Inc. | 2004 | — |
| +1 | K080818 | Hemcon Bandage, Hemcon Bandage Otc, Hemcon Chitoflex-Surgical Dressing | Hem Con Medical Technologies, Inc. | 2008 | — |
| +1 | K070175 | Aquanova Super-Absorbent Gelling Dressing, Otc | Medtrade Products, Ltd. | 2007 | — |
| +2 | K090620 | Quikclot Inteventional, Model P/N 182 | Z-Medica Corporation | 2009 | — |
| +1 | K150916 | HemCon Bandage PRO, HemCon Patch PRO, HemCon Strip PRO, HemCon Strip First Aid… | Hem Con Medical Technologies, Inc. | 2015 | — |
| +2 | K143124 | KA01 Chitosan Wound Dressing | Foshan United Medical Technologies, Ltd. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 4 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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? (4)
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 |
|---|---|---|---|
| * | K024298 | Antimicrobial Alginate DressingSummary page 5…Name: Classification: Unclassified Classification Topical Wound Dressing Pad Name: Predicate * Advanced Medical Solutions, LTD. - K024298 - Device: Antimicrobial Dressing * Perclose, Inc. - K021062 - ChitoSeal… | 2003 |
| * | K021062 | Chito-SealSummary page 5…Predicate * Advanced Medical Solutions, LTD. - K024298 - Device: Antimicrobial Dressing * Perclose, Inc. - K021062 - ChitoSeal · T-Scientific, Inc. - K030334 - T-PAD · Marine Polymer Technol… | 2002 |
| * | K030334 | T-Scientific T-PadSummary page 5…- Device: Antimicrobial Dressing * Perclose, Inc. - K021062 - ChitoSeal · T-Scientific, Inc. - K030334 - T-PAD · Marine Polymer Technologies - K984177 - SyvekPatch Device… | 2003 |
| * | K984177 | Modification to SkvekpatchSummary page 5…* Perclose, Inc. - K021062 - ChitoSeal · T-Scientific, Inc. - K030334 - T-PAD · Marine Polymer Technologies - K984177 - SyvekPatch Device The Scion Cardio-Vascular CIo-Sur.PL US P.A.D. is a soft,… | 1998 |
What descends from it? (25)
See all 257 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K080818 | Hemcon Bandage, Hemcon Bandage Otc, Hemcon Chitoflex-Surgical Dressing | 2008 | 11 |
| K070175 | Aquanova Super-Absorbent Gelling Dressing, Otc | 2007 | 6 |
| K150916 | HemCon Bandage PRO, HemCon Patch PRO, HemCon Strip PRO, HemCon Strip First Aid PRO… | 2015 | 3 |
| K102944 | Coreleader Hemo-Pad Model Cpii 02030 | 2011 | 2 |
| K090100 | Softseal-STF | 2009 | 2 |
| K161013 | InnoSEAL Hemostatic Pad | 2016 | 0 |
| K150963 | AnsCare ChitoClot Pad | 2015 | 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 13 years and passes through 5 companies; a new generation was cleared every 2.4 years on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K080818 (Hem Con Medical Technologies, Inc., 2008) has gone furthest, with 11 descendants of its own.
- 3 other devices also cite its predicate K024298.
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?
The Scion Cardio-Vascular CIo-Surf Lus P.A.D., is intended for the local management of bleeding wounds and to provide a barrier to bacterial penetration of the dressing in all patients and for the promotion of rapid control (hemostasis) of bleeding in patients following hemodialysis and for those on anticoagulation therapy. The dressing is indicated for the following wounds: lacerations, abrasions, nose bleeds, and the skin surface puncture sites for vascular procedures, percutaneous catheters or tubes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032986 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032986: Clo-Surplusp.a.D..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032986
Report an extraction error
Are you the manufacturer?
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