# K062540: Nasopore Ear, Models  ND04, ND05

- Pathway: 510(k) (Traditional)
- Applicant: Polyganics B.V.,
- Decided: Oct 18, 2006 after 49 days
- Product code: KCN (Ear Wick)
- Device class: 1
- Regulation: 21 CFR 874.5220
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K972082 (1997). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973578: Invotec Ear Tampon (Wick) W/String, Invotec International, Inc. (1997) Summary page 1.
- K052099: Nasopore Nasal Dressing, Model Ndox-Yyy/ZZ, Polyganics B.V., (2005) Summary page 1.

## Indications for use
Nasopore® Ear is a fragmentable ear packing and is indicated for use in patients, undergoing ear surgery, as a space occupying stent to separate and prevent adhesions between mucosal surfaces; to help control mini- mal bleeding, following ear surgery, by tamponade effect and blood ab- sorption.

Source page: https://510kreport.com/device/K062540
Methodology: https://510kreport.com/methodology