510(k) Report

FDA applicant

Sis Ltd., Surgical Instrument Systems

Littleton, CO3 decisions2005–20090 recalls

FDA records 3 decisions for Sis Ltd., Surgical Instrument Systems (Littleton, CO) from 2005 to 2009: 3 510(k) clearances. Most are in product codes MSS (Folders And Injectors, Intraocular Lens (Iol)) and MXK (Device, Analysis, Anterior Segment). Its devices cite 4 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 Sis Ltd., Surgical Instrument Systems’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2009: 1
2007high 1 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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

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Which product codes does it file in?

  • MSSFolders And Injectors, Intraocular Lens (Iol)1decision
  • MXKDevice, Analysis, Anterior Segment1decision
  • HNOKeratome, Ac-Powered1decision

Whose devices does it build on?

Its devices cite 4 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.

  • K051940CM 3910 Rotating Double Scheimpflug CameraSis Ltd., Surgical Instrument Systems · 20052cite it

What has FDA decided for it lately?

  • K082871Xact Lens Inserter System, Models 6MM, 7MMSis Ltd., Surgical Instrument Systems · 2009
  • K051940CM 3910 Rotating Double Scheimpflug CameraSis Ltd., Surgical Instrument Systems · 2005
  • K043150Amadeus II EpikeratomeSis Ltd., Surgical Instrument Systems · 2005

All 3 as Sis Ltd., Surgical Instrument Systems →