# K983276: Hydrofera Bacteristatic Nasal Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Hydrofera, LLC
- Decided: Sep 14, 1999 after 362 days
- Product code: EMX (Balloon, Epistaxis)
- Device class: 1
- Regulation: 21 CFR 874.4100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K013462: Hydrofera Bacteriostatic Wound Dressing (2002), 3 descendants of its own
- K060832: Retro-Tech Dressing (2007), 2 descendants of its own
- K130670: Hydrofera Blue PU Bacteriostatic Dressing (2014), 1 descendant of its own
- K220326: PosiSep X BAM Hemostat Dressing/Intranasal Splint (2022), 0 descendants of its own
- K190268: Hydrofera Blue READY - Border (2019), 0 descendants of its own

## Indications for use
POST OPERATIVE PACKING AFTER SEPTAL RHINOPLASTIG, OR TURBINATE SURGERY.

Source page: https://510kreport.com/device/K983276
Methodology: https://510kreport.com/methodology