510(k) · Cleared
ClearedAlgiseal Pad
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Evolution Medical Technologies, LLC · QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Cleared on May 18, 2009 as substantially equivalent to K941176 (Adri/Technam, 1994) and 2 other predicates after a 25-day review. Its family tree reaches back 3 generations to 1998. 1 later device descends from it.
- Decided
- May 18, 2009
- Review
- 25 days
- Class
- Class U
- Product code
- QSY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K984177 (1998). 6 ancestors in all, the oldest K914779 (1991). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK984177 Modification to SkvekpatchMarine Polymer Technologies, Inc. · 1998
- 2 generations backK021062 Chito-SealAbbott Vascular, Inc. · 2002
- 1 generation backK040208 Neptune Pad, Neptune Disc, Neptune Comfort-Band, Comfort-BandTz Medical, Inc. · 2004 · Recalled
- This deviceK091194 Algiseal PadEvolution Medical Technologies, LLC · 2009
- Descendant · cites it directly · 0 of its ownK101097 Calgaeseal Model: CasBz Medical, Inc. · 2010
Most influential descendants
Showing 1 of 1 · See all- K101097Calgaeseal Model: CasBz Medical, Inc. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K984177 | Modification to Skvekpatch | Marine Polymer Technologies, Inc. | 1998 | — |
| −2 | K021062 | Chito-Seal | Abbott Vascular, Inc. | 2002 | — |
| −1 | K040208 | Neptune Pad, Neptune Disc, Neptune Comfort-Band, Comfort-Band | Tz Medical, Inc. | 2004 | 1 |
| 0 (this device) | K091194 | Algiseal Pad | Evolution Medical Technologies, LLC | 2009 | — |
| +1 | K101097 | Calgaeseal Model: Cas | Bz Medical, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K941176 | Alginate FiberSummary page 5…E INFORMATION SUMMARY C A. Predicate Device Kaiginate by DeRoyal (K941 176) (K914779) Neptune Pad by TZ Medi… | 1994 |
| * | K914779 | Alginate FiberSummary page 5…Kaiginate by DeRoyal (K941 176) (K914779) Neptune Pad by TZ Medical (K040208) B. Device Intended Use Al… | 1991 |
| * | K040208 | Neptune Pad, Neptune Disc, Neptune Comfort-Band, Comfort-BandSummary page 5…(K914779) Neptune Pad by TZ Medical (K040208) B. Device Intended Use Algiseal products are used to promote the rapid control of bleeding and hemostasis for… | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101097 | Calgaeseal Model: Cas | 2010 | 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 11 years and passes through 4 companies; a new generation was cleared every 3.7 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K101097 (Bz Medical, Inc., 2010) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K941176.
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. 2009, 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?
Algiseal Pad (calcium alginate pad alone and pad with permeable adhesive backing): Algiseal Pad is used to promote the rapid control of bleeding and provide hemostasis for lacerations, abrasions, vascular access sites and following sirgical incision. It can be used to achieve hemostasis at the skin surface for arterial/venous catheterization/tubes, needle puncture, hemodialysis patients and in patients on anticoagulation therapy. May be used in conjunction with a facility approved, post-hemostasis site dressing.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091194 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091194: Algiseal Pad.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091194
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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