510(k) Report

FDA applicant

Surgical Instrument Systems (Sis), Ltd.

Irvine, CA1 decision2000–20000 recalls

FDA records 1 decision for Surgical Instrument Systems (Sis), Ltd. (Irvine, CA) in 2000: 1 510(k) clearance. All are in product code HNO (Keratome, Ac-Powered). Its devices cite 2 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, ophthalmic panel, where it files most

How often FDA has decided Surgical Instrument Systems (Sis), Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Surgical Instrument Systems (Sis), Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Surgical Instrument Systems (Sis), Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Surgical Instrument Systems (Sis), Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • HNOKeratome, Ac-Powered1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K993190Advanced Computer Controlled Microkeratome-Accm, Model Surgical Instrument Systems (Sis)Surgical Instrument Systems (Sis), Ltd. · 20002cite it

What has FDA decided for it lately?

  • K993190Advanced Computer Controlled Microkeratome-Accm, Model Surgical Instrument Systems (Sis)Surgical Instrument Systems (Sis), Ltd. · 2000

The one decision as Surgical Instrument Systems (Sis), Ltd. →