# K961820: Storz DP4600 Anterior Intraocular Pressure Control Pack

- Pathway: 510(k) (Traditional)
- Applicant: Storz Instrument Co.
- Decided: Jul 25, 1996 after 76 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 K894278 (1989). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 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.
- K953078: Storz DP4101 Basic I/a Pack, Storz Instrument Co. (1995) Summary page 1.

## Indications for use
This component is to be used as an accessory to the Storz PREMIERE® (K894278, K921460, and K946227) and Storz DAISY™ (K854508) Microsurgical Systems in the maintenance of intraocular pressure (IOP) during anterior segment ophthalmic surgical procedures.

Source page: https://510kreport.com/device/K961820
Methodology: https://510kreport.com/methodology