# K955901: Storz DP4310DELUXE Phaco Pack Without Reflux

- Pathway: 510(k) (Traditional)
- Applicant: Storz Instrument Co.
- Decided: Mar 28, 1996 after 90 days
- Product code: HQC (Unit, Phacofragmentation)
- Device class: 2
- Regulation: 21 CFR 886.4670
- 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 K882240 (1988). 1 ancestor in all.
4 later devices descend from it; 4 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K882240: Storz Univ Irrigat/Aspira & Phacoemulsifcation Pac, Storz Instrument Co. (1988) Summary page 1.

## Most influential descendants
- K980100: Storz DP4210 Venturi Economy Anterior Pack and DP5000 Asc  Daypack (1998), 1 descendant of its own
- K961831: Storz DP5200 Irrigation Addministration Set Pack (1996), 1 descendant of its own
- K033653: Venturi Phaco Pack (2003), 0 descendants of its own
- K990292: I/a (Irrigation/Aspiration) Pack, Posterior Vitrecomy Pack, Anterior Virectomy Pack, Phacoemulsification Pack, Admiinisn (1999), 0 descendants of its own

## Indications for use
Irrigation/Aspiration and Phacoemulsification

Source page: https://510kreport.com/device/K955901
Methodology: https://510kreport.com/methodology