# K920358: Ultracell Nasal Packing

- Pathway: 510(k) (Traditional)
- Applicant: Ultracell Medical Technologies, Inc.
- Decided: Nov 30, 1992 after 308 days
- Product code: EMX (Balloon, Epistaxis)
- Device class: 1
- Regulation: 21 CFR 874.4100
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K964113: Ivalon Nasal Packing W/Drawstring (8.0CM & 4.5CM), Ivalon Nasal Packing W/Airway Tube & Drawstring, Ivalon Contour Nasal (1996), 0 descendants of its own

## Recalls of this device
- Jan 8, 2003 · Not classified · Z-0478-03: Sterility of the device is compromised
- Jan 8, 2003 · Not classified · Z-0486-03: Sterility of the device is compromised
- Jan 8, 2003 · Not classified · Z-0490-03: Sterility of the device is compromised

Source page: https://510kreport.com/device/K920358
Methodology: https://510kreport.com/methodology