# K962131: Storz D4600 Air Exchange Line Pack

- Pathway: 510(k) (Traditional)
- Applicant: Storz Instrument Co.
- Decided: Aug 23, 1996 after 81 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 K832761 (1983). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K894278: Storz Daisyplus Series Microsurgical Systems, Storz Instrument Co. (1989) Summary page 1.
- K832761: Air Fluid Exchange Pump, Intek Int'L, Inc. (1983) Summary page 1.

## Most influential descendants
- K082132: Bausch & Lomb D4600A Air Exchange Line Pack (2008), 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
The Storz D4600 is intended to be used as an accessory to the Storz PREMIERE® (K894278, K921460, K946227) or Storz DAISY® (K854508) Microsurgical Systems for use in air and fluid exchange during posterior segment ophthalmic surgical procedures. The D4600 Air Exchange Line provides the initial pathway through which air generated by the microsurgical system is routed into the posterior chamber of the eye.

Source page: https://510kreport.com/device/K962131
Methodology: https://510kreport.com/methodology