510(k) · Cleared
ClearedInnoSEAL Hemostatic Pad
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innotherapy, Inc. · QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Cleared on Nov 29, 2016 as substantially equivalent to K032986 (Scion Cardio-Vascular, Inc., 2004) and 1 other predicate after a 232-day review. Its family tree reaches back 6 generations to 1991.
- Decided
- Nov 29, 2016
- Review
- 232 days
- Class
- Class U
- Product code
- QSY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K914575 (1991). 12 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK914575 Sorbsan Topical Wound Dressing (Modified)Dow B. Hickam, Inc. · 1991
- 5 generations backK983210 Algisite MSmith & Nephew, Inc. · 1998
- 4 generations backK002896 Acticoat Foam Dressing, Algisite M Calcium Alginate DressingThe Westaim Corp. · 2001
- 3 generations backK024298 Antimicrobial Alginate DressingAdvanced Medical Solutions, Ltd. · 2003
- 2 generations backK032986 Clo-Surplusp.a.D.Scion Cardio-Vascular, Inc. · 2004
- 1 generation backK102944 Coreleader Hemo-Pad Model Cpii 02030Coreleader Biotech Co., Ltd. · 2011
- This deviceK161013 InnoSEAL Hemostatic PadInnotherapy, Inc. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K914575 | Sorbsan Topical Wound Dressing (Modified) | Dow B. Hickam, Inc. | 1991 | — |
| −5 | K983210 | Algisite M | Smith & Nephew, Inc. | 1998 | — |
| −4 | K002896 | Acticoat Foam Dressing, Algisite M Calcium Alginate Dressing | The Westaim Corp. | 2001 | — |
| −3 | K024298 | Antimicrobial Alginate Dressing | Advanced Medical Solutions, Ltd. | 2003 | — |
| −2 | K032986 | Clo-Surplusp.a.D. | Scion Cardio-Vascular, Inc. | 2004 | — |
| −1 | K102944 | Coreleader Hemo-Pad Model Cpii 02030 | Coreleader Biotech Co., Ltd. | 2011 | — |
| 0 (this device) | K161013 | InnoSEAL Hemostatic Pad | Innotherapy, Inc. | 2016 | — |
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 |
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? (2)
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 |
|---|---|---|---|
| * | K032986 | Clo-Surplusp.a.D.Summary page 5…Device Class: Unclassified Product Code: FRO (3) PREDICATE DEVICE: Substantial equivalence is based on following legally marketed devices. - Clo-Sur Plus P.A.D (K032986 March 1, 2004) - Coreleader Hemo Pad (K102944 September 7, 2011) The predicates have not been subject to a design-relate… | 2004 |
| * | K102944 | Coreleader Hemo-Pad Model Cpii 02030Summary page 5…(3) PREDICATE DEVICE: Substantial equivalence is based on following legally marketed devices. - Clo-Sur Plus P.A.D (K032986 March 1, 2004) - Coreleader Hemo Pad (K102944 September 7, 2011) The predicates have not been subject to a design-related recall. No reference devices were used in th… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
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 25 years and passes through 7 companies; a new generation was cleared every 5.2 years on median.
- 1 of the 12 ancestors has a recall of any class.
- 6 other devices also cite its predicate K032986.
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. 2016, 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?
InnoSEAL Hemostatic Pad is intended for the local management of bleeding wounds and for the promotion of rapid control of bleeding. InnoSEAL Hemostatic Pad is intended for use under the care of a healthcare professional.
The dressing is indicated for following wounds; lacerations, abrasions and the skin surface puncture sites for vascular procedures, percutaneous catheters/tubes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161013 · printed Nov 5, 2026
Cite this page
510(k) Report. “K161013: InnoSEAL Hemostatic Pad.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K161013
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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