510(k) · Cleared
ClearedHydrofera Bacteristatic Nasal Dressing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hydrofera, LLC · EMX Balloon, Epistaxis
Cleared on Sep 14, 1999 after a 362-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 5 later devices descend from it.
- Decided
- Sep 14, 1999
- Review
- 362 days
- Class
- Class I
- Product code
- EMX
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK983276 Hydrofera Bacteristatic Nasal DressingHydrofera, LLC · 1999
- Descendant · cites it directly · 3 of its ownK013462 Hydrofera Bacteriostatic Wound DressingHydrofera, LLC · 2002
- Descendant · 2 generations on · 2 of its ownK060832 Retro-Tech DressingRetro-Tech, LLC · 2007
- Descendant · 2 generations on · 1 of its ownK130670 Hydrofera Blue PU Bacteriostatic DressingHydrofera, LLC · 2014
- Descendant · cites it directly · 0 of its ownK220326 PosiSep X BAM Hemostat Dressing/Intranasal SplintHemostasis, LLC · 2022
- Descendant · 3 generations on · 0 of its ownK190268 Hydrofera Blue READY - BorderHydrofera, LLC · 2019
Most influential descendants
Showing 5 of 5 · See all- K013462Hydrofera Bacteriostatic Wound DressingHydrofera, LLC · 2002 · cites it directly3descendants
- K060832Retro-Tech DressingRetro-Tech, LLC · 2007 · 2 generations on2descendants
- K130670Hydrofera Blue PU Bacteriostatic DressingHydrofera, LLC · 2014 · 2 generations on1descendant
- K220326PosiSep X BAM Hemostat Dressing/Intranasal SplintHemostasis, LLC · 2022 · cites it directly0descendants
- K190268Hydrofera Blue READY - BorderHydrofera, LLC · 2019 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K983276 | Hydrofera Bacteristatic Nasal Dressing | Hydrofera, LLC | 1999 | — |
| +1 | K013462 | Hydrofera Bacteriostatic Wound Dressing | Hydrofera, LLC | 2002 | — |
| +2 | K060832 | Retro-Tech Dressing | Retro-Tech, LLC | 2007 | — |
| +2 | K130670 | Hydrofera Blue PU Bacteriostatic Dressing | Hydrofera, LLC | 2014 | — |
| +1 | K220326 | PosiSep X BAM Hemostat Dressing/Intranasal Splint | Hemostasis, LLC | 2022 | — |
| +3 | K190268 | Hydrofera Blue READY - Border | Hydrofera, LLC | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2007 | 1 | 0 |
| 2014 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 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 EMX? 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 EMX device
- #1 K220326 PosiSep X BAM Hemostat Dressing/Intranasal…score 4.4 · 1 generation · no Class I recall
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (5)
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, K013462 (Hydrofera, LLC, 2002) has gone furthest, with 3 descendants of its own.
How does its category compare?
All EMX devicesEMX Balloon, Epistaxis: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EMX
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · EMX
Too few EMX 510(k)s in any year since 2007 to give a median.
Recalls per year · EMX
No recall names EMX since 2007.
Adverse event reports per year · EMX
16in 2025
MAUDE reports naming product code EMX, 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 | 3 |
| 2008 | 0 | — | 0 | 3 |
| 2009 | 0 | — | 0 | 3 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 0 | — | 0 | 10 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 3 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 12 |
| 2020 | 0 | — | 0 | 5 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 12 |
| 2025 | 0 | — | 0 | 16 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
POST OPERATIVE PACKING AFTER SEPTAL RHINOPLASTIG, OR TURBINATE SURGERY.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K983276 · printed Nov 4, 2026
Cite this page
510(k) Report. “K983276: Hydrofera Bacteristatic Nasal Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983276
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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