# K962133: Expandacell Injecto-Pak

- Pathway: 510(k) (Traditional)
- Applicant: Shippert Medical Technologies Corp.
- Decided: Aug 1, 1996 after 59 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 K935724 (1994). 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)
- K935724: The Expandacell Sinus Pack, Denver Splint Co. (1994) Summary page 1.
- K954845: Expandacell Injecto-Pak Nasal Pack, Shippert Medical Technologies Corp. (1995) Summary page 1.
- K960228: Expandacell Injecto-Pak Nasal Pack, Shippert Medical Technologies Corp. (1996) Summary page 1.

## Indications for use
For administration of liquid medication and hydrating for the sinus.

Source page: https://510kreport.com/device/K962133
Methodology: https://510kreport.com/methodology