510(k) · Cleared
Cleared3M Tegagen HI Alginate Dressing & 3 M Tegagen HG Alginate Dressing, Model #'S 90110,90112,90114,90120, 90210,90212,90214
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innovative Technologies, Ltd. · QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Cleared on Aug 21, 1998 as substantially equivalent to K953781 (Innovative Technologies, Ltd., 1995) and 1 other predicate after a 23-day review. Its family tree reaches back 2 generations to 1995.
- Decided
- Aug 21, 1998
- Review
- 23 days
- Class
- Class U
- Product code
- QSY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K953781 (1995). No later device cites it as a predicate yet.
- Root · 2 generations backK953781 Innovative Technologies Calcium Alginate Wound DressingsInnovative Technologies, Ltd. · 1995
- 1 generation backK980989 3M Tegagen HI Alginate Dressing & 3M Tegagen HG Alginate DressingInnovative Technologies, Ltd. · 1998
- This deviceK982638 3M Tegagen HI Alginate Dressing & 3 M Tegagen HG Alginate Dressing…Innovative Technologies, Ltd. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K953781 | Innovative Technologies Calcium Alginate Wound Dressings | Innovative Technologies, Ltd. | 1995 | — |
| −1 | K980989 | 3M Tegagen HI Alginate Dressing & 3M Tegagen HG Alginate Dressing | Innovative Technologies, Ltd. | 1998 | — |
| 0 (this device) | K982638 | 3M Tegagen HI Alginate Dressing & 3 M Tegagen HG Alginate Dressing, Model #'S… | Innovative Technologies, Ltd. | 1998 | — |
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 |
|---|---|---|---|
| * | K953781 | Innovative Technologies Calcium Alginate Wound DressingsSummary page 6…intended for use except as indicated. Substantial equivalence was provided in 510{k) K253781 and K980989. Biocompatibility test results are as those presented in both K953781 and K880989 and therefore are not re submitted. | 1995 |
| * | K980989 | 3M Tegagen HI Alginate Dressing & 3M Tegagen HG Alginate DressingSummary page 6…to help control minor bleeding. This product is not designed, sold, or intended for use except as indicated. Substantial equivalence was provided in 510{k) K253781 and K980989. Biocompatibility test results are as those presented in both K953781 and K880989 and therefore are not re submitted. | 1998 |
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 3 years and passes through 1 company; a new generation was cleared every 2.7 years on median.
- None of the 2 ancestors has a recall.
- 2 other devices also cite its predicate K953781.
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?
Tegagen HI & HG alginate dressings are intended for use on partial and full thickness wounds with moderate to heavy exudate, eg:
Pressure ulcers
Arterial Ulcers
Venous ulcers
Diabetic ulcers
Superficial wounds; such as cuts and abrasions
Donor wounds o
Post-operative wounds
Trauma wounds
Dermal lesions
Tegagen HI & HG alginate dressings are also intended to help control minor bleeding.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K982638 · printed Nov 4, 2026
Cite this page
510(k) Report. “K982638: 3M Tegagen HI Alginate Dressing & 3 M Tegagen HG Alginate Dressing, Model #'S 90110,90112,90114,90120, 90210,90212,90214.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982638
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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