# K012579: Reprocessed Phaco Tips

- Pathway: 510(k) (Traditional)
- Applicant: Sterilmed, Inc.
- Decided: Nov 8, 2001 after 91 days
- Product code: NKX (Needle, Phacoemulsification, Reprocessed)
- Device class: 2
- Regulation: 21 CFR 886.4670
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K851210 (1985). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981103: Turbosonics Limited Reuse Ultrasonic Tip, Alcon Laboratories (1998) Summary page 5.
- K914229: Phaco Tip, Tri-Star Ophthalmic (1991) Summary page 5.
- K943102: High Performance Tips, Surgin Surgical Instrumentation, Inc. (1994) Summary page 5.

## Recalls of this device
- Aug 8, 2008 · Not classified · Z-0565-2009: SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed within a pouch. The removal is being conducted because the possibility exists that some of th

## Indications for use
The intended use of this device is to assist in the automated phacoemulsification of a natural crystalline lens.

Source page: https://510kreport.com/device/K012579
Methodology: https://510kreport.com/methodology