# K990292: I/a (Irrigation/Aspiration) Pack, Posterior Vitrecomy Pack, Anterior Virectomy Pack, Phacoemulsification Pack, Admiinisn

- Pathway: 510(k) (Traditional)
- Applicant: Ophthalmic Consultants, Inc.
- Decided: Nov 19, 1999 after 294 days
- Product code: HQE (Instrument, Vitreous Aspiration And Cutting, Ac-Powered)
- Device class: 2
- Regulation: 21 CFR 886.4150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K882240 (1988). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980100: Storz DP4210 Venturi Economy Anterior Pack and DP5000 Asc  Daypack, Storz Instrument Co. (1998) Summary page 2.
- K962131: Storz D4600 Air Exchange Line Pack, Storz Instrument Co. (1996) Summary page 2.
- K961874: Storz DP5100 Anterior Collection Cassette Pack, Storz Instrument Co. (1996) Summary page 2.
- K961831: Storz DP5200 Irrigation Addministration Set Pack, Storz Instrument Co. (1996) Summary page 2.
- K955901: Storz DP4310DELUXE Phaco Pack Without Reflux, Storz Instrument Co. (1996) Summary page 2.
- K953575: Storz MVS-3201 Vitrectomy Probe Pack, Storz Instrument Co. (1995) Summary page 2.
- K913504: Storz Micro Cutter 25 Gauge Pack, Storz (1992) Summary page 2.

## Indications for use
To provide single-use components to be used in conjunction with a facility’s existing compatable equipment, in one convenient kit/pack, for ophthalmic surgical procedures, used in accordance with the equipment manufacturer’s instructions, performed by a certified clinician in a clinical setting, as follows: 01. Phaco Emulsifier Pack: Provides the irrigation and aspiration tubing/ administration sets and equipment covers/drapes used in anterior, e.g., cataract, surgical procedures; 02. Anterior Vitrectomy Pack: Provides the vitrector, surgical blade, scleral plugs for incision patency, and 10 cc syringe and fluid irrigation and aspiration tubing/administration sets, and equipment covers/drapes, used in anterior surgical procedures; 03. Anterior Collection Cassette: Provides the fluid collection cassette and tubing for the collection and disposal of fluids during ophthalmic anterior surgical procedures; 04. Posterior Vitrectomy Pack: Provides the vitrector, surgical blade, scleral plugs for incision patency, and 10 cc syringe and fluid irrigation and aspiration tubing/administration sets, and equipment covers/drapes, used in posterior segment, e.g., retinal, surgical procedures; 05. Posterior Collection Cassette: Provides the fluid collection cassette and tubing for the collection and disposal of fluids during ophthalmic posterior surgical procedures. 06. Filtered Irrigation Administration Set: Provides commonly used tubing sets for the filtering and administration of fluids for flushing/irrigating a surgical site during either posterior or anterior ophthalmic procedures.

Source page: https://510kreport.com/device/K990292
Methodology: https://510kreport.com/methodology