# K964113: Ivalon Nasal Packing W/Drawstring (8.0CM & 4.5CM), Ivalon Nasal Packing W/Airway Tube & Drawstring, Ivalon Contour Nasal

- Pathway: 510(k) (Traditional)
- Applicant: M-Pact Worldwide Management Corp.
- Decided: Nov 7, 1996 after 23 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
Longest line of descent: 1 generation back to K900171 (1990). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K920358: Ultracell Nasal Packing, Ultracell Medical Technologies, Inc. (1992) Summary page 1.
- K900171: Expandacel Nasal Tampons, Surgitrend, Ltd. (1990). Our OCR of the scanned summary read K990171, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Expandacell Nasal Tampon”.
- K912524: Expandacel Nasal Tampons, Modification, Surgitrend, Ltd. (1991) Summary page 1.
- (no number) Merocel Nasal Packing: named in the summary without a submission number
- (no number) Merocel Nasal Pack: named in the summary without a submission number
- (no number) Kennedy Sinus Pack: named in the summary without a submission number

## Indications for use
Nasal and sinus packings are used to absorb excess body fluids after septal, turbinate, or rhinoplastic surgery or endoscopic sinus surgery, and for the control of epistaxis (i.e., nose bleeds). They are packaged individually as a sterile, dried and compressed sponge that is inserted into the nasal or sinus cavity. When expanded via absorption of blood after insertion, the nasal packing is intended to fill the necessary space to prevent lateral motion of the turbinate and provide gentle pressure on the mucosa. The sinus packing is intended to selectively pack only the ostiomeatal complex leaving the nasal cavity clear for breathing.

Source page: https://510kreport.com/device/K964113
Methodology: https://510kreport.com/methodology