510(k) · Cleared
ClearedAlginate Fiber
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Adri/Technam · NAC Dressing, Wound, Hydrophilic
Cleared on Dec 4, 1991 after a 42-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 later devices descend from it.
- Decided
- Dec 4, 1991
- Review
- 42 days
- Class
- Class I
- Product code
- NAC
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K914779 | Alginate Fiber | Adri/Technam | 1991 | — |
| +1 | K091194 | Algiseal Pad | Evolution Medical Technologies, LLC | 2009 | — |
| +1 | K101097 | Calgaeseal Model: Cas | Bz Medical, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NAC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K091194 (Evolution Medical Technologies, LLC, 2009) has gone furthest, with 1 descendant of its own.
How does its category compare?
All NAC devicesNAC Dressing, Wound, Hydrophilic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NAC
1in 2008
2026 to Oct 25, outlined.
Median 510(k) review, days · NAC
Too few NAC 510(k)s in any year since 2007 to give a median.
Recalls per year · NAC
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NAC
83in 2025
MAUDE reports naming product code NAC, 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 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 2 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 20 |
| 2014 | 0 | — | 0 | 97 |
| 2015 | 0 | — | 0 | 243 |
| 2016 | 0 | — | 1 | 59 |
| 2017 | 0 | — | 0 | 26 |
| 2018 | 0 | — | 0 | 221 |
| 2019 | 0 | — | 0 | 67 |
| 2020 | 0 | — | 0 | 137 |
| 2021 | 0 | — | 0 | 57 |
| 2022 | 0 | — | 0 | 71 |
| 2023 | 0 | — | 0 | 115 |
| 2024 | 0 | — | 3 | 35 |
| 2025 | 0 | — | 0 | 83 |
| 2026 | 0 | — | 1 | — |
https://510kreport.com/device/K914779 · printed Nov 6, 2026
Cite this page
510(k) Report. “K914779: Alginate Fiber.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K914779
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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