510(k) · Cleared
ClearedCalgaeseal Model: Cas
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bz Medical, Inc. · QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Cleared on Sep 22, 2010 as substantially equivalent to K914779 (Adri/Technam, 1991) and 2 other predicates after a 155-day review. Its family tree reaches back 4 generations to 1998.
- Decided
- Sep 22, 2010
- Review
- 155 days
- Class
- Class U
- Product code
- QSY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K984177 (1998). 7 ancestors in all, the oldest K914779 (1991). No later device cites it as a predicate yet.
- Root · 4 generations backK984177 Modification to SkvekpatchMarine Polymer Technologies, Inc. · 1998
- 3 generations backK021062 Chito-SealAbbott Vascular, Inc. · 2002
- 2 generations backK040208 Neptune Pad, Neptune Disc, Neptune Comfort-Band, Comfort-BandTz Medical, Inc. · 2004 · Recalled
- 1 generation backK091194 Algiseal PadEvolution Medical Technologies, LLC · 2009
- This deviceK101097 Calgaeseal Model: CasBz Medical, Inc. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K984177 | Modification to Skvekpatch | Marine Polymer Technologies, Inc. | 1998 | — |
| −3 | K021062 | Chito-Seal | Abbott Vascular, Inc. | 2002 | — |
| −2 | K040208 | Neptune Pad, Neptune Disc, Neptune Comfort-Band, Comfort-Band | Tz Medical, Inc. | 2004 | 1 |
| −1 | K091194 | Algiseal Pad | Evolution Medical Technologies, LLC | 2009 | — |
| 0 (this device) | 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 |
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? (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 |
|---|---|---|---|
| * | K914779 | Alginate FiberSummary page 5…tasis Pad Classification Name: Dressing, Wound, Drug 3 Predicate Devices: a. DeRoyal Industries Kalginate K9 14779 b. TZ Medical Neptune K040208 c. Evolution Medical Tech. Algisea… | 1991 |
| * | K040208 | Neptune Pad, Neptune Disc, Neptune Comfort-Band, Comfort-BandSummary page 5…Drug 3 Predicate Devices: a. DeRoyal Industries Kalginate K9 14779 b. TZ Medical Neptune K040208 c. Evolution Medical Tech. Algiseal Pad K091 194 4 Device Description: CalgaeSeal is calc… | 2004 |
| * | K091194 | Algiseal PadSummary page 5…Kalginate K9 14779 b. TZ Medical Neptune K040208 c. Evolution Medical Tech. Algiseal Pad K091 194 4 Device Description: CalgaeSeal is calcium alginate packaged in a Tyvek and Mylar pouch and sterilized… | 2009 |
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 12 years and passes through 5 companies; a new generation was cleared every 3.7 years on median.
- 1 of the 7 ancestors has a recall of any class.
- 1 other device also cites its predicate K914779.
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. 2010, 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?
CalgaeSeal is used to promote the rapid control of bleeding and provide hemostasis for lacerations, abrasions, vascular access sites and following surgical incisions. It can be used to achieve hemostasis at the skin surface for arterial/venous catheterization/tubes, needle puncture, hemodialysis 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/K101097 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101097: Calgaeseal Model: Cas.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101097
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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