# K070715: Nasopore Ear

- Pathway: 510(k) (Traditional)
- Applicant: Polyganics B.V.,
- Decided: May 7, 2007 after 54 days
- Product code: NHB (Polymer, Ear, Nose And Throat, Synthetic, Absorbable)
- Device class: 2
- Regulation: 21 CFR 874.3620
- Recalls of this device: 13 (0 Class I)
- 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.
1 later device descends from it; 1 cites it directly.
0 of 9 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.

## Most influential descendants
- K210411: PosiSep EAR Fragmentable Ear Dressing (2022), 0 descendants of its own

## Recalls of this device
- Feb 25, 2025 · Class II · Z-1472-2025: There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal h
- Feb 25, 2025 · Class II · Z-1471-2025: There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal h
- Feb 25, 2025 · Class II · Z-1470-2025: There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal h
- Feb 25, 2025 · Class II · Z-1473-2025: There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal h
- Feb 25, 2025 · Class II · Z-1478-2025: There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal h
- Feb 25, 2025 · Class II · Z-1481-2025: There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal h
- Feb 25, 2025 · Class II · Z-1476-2025: There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal h
- Feb 25, 2025 · Class II · Z-1469-2025: There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal h
- Feb 25, 2025 · Class II · Z-1480-2025: There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal h
- Feb 25, 2025 · Class II · Z-1475-2025: There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal h
- Feb 25, 2025 · Class II · Z-1479-2025: There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal h
- Feb 25, 2025 · Class II · Z-1477-2025: There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal h
- Feb 25, 2025 · Class II · Z-1482-2025: There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal h

## 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 minimal bleeding, following ear surgery, by tamponade effect and blood absorption.

Source page: https://510kreport.com/device/K070715
Methodology: https://510kreport.com/methodology