# K141816: Hemopore

- Pathway: 510(k) (Traditional)
- Applicant: Polyganics B.V.,
- Decided: Oct 23, 2014 after 108 days
- Product code: LYA (Splint, Intranasal Septal)
- Device class: 1
- Regulation: 21 CFR 874.4780
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K896068 (1990). 42 ancestors in all.
No later device cites it as a predicate yet.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052099: Nasopore Nasal Dressing, Model Ndox-Yyy/ZZ, Polyganics B.V., (2005) Summary page 4.
- K122494: Posisep and Posisep X Hemostat Dressing/Intranasal Splint, Hemostasis, LLC (2013) Summary page 4.

## Indications for use
HEMOPORE® is intended for use in patients undergoing nasal/sinus surgery as a temporary wound dressing. HEMOPORE® functions as a topical hemostatic aid to control mild bleeding by tamponade effect, blood absorption, platelet activation and aggregation. It acts as an adjunct to aid in the natural healing process as a space occupying stent to separate and support tissues. It prevents adhesions and minimizes edema.

Source page: https://510kreport.com/device/K141816
Methodology: https://510kreport.com/methodology