510(k) Report

FDA applicant

Langford IC Systems, Inc.

Tucson, AZ3 decisions2005–20110 recalls

FDA records 3 decisions for Langford IC Systems, Inc. (Tucson, AZ) from 2005 to 2011: 3 510(k) clearances. Most are in product codes FEB (Accessories, Cleaning, For Endoscope) and NVE (Washer, Cleaner, Automated, Endoscope). Its devices cite 5 predicates, 2 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, gastroenterology and urology panel, where it files most

How often FDA has decided Langford IC Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2011: 1
2007high 1 (2011) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Langford IC Systems, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Langford IC Systems, Inc.’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?

  • FEBAccessories, Cleaning, For Endoscope2decisions
  • NVEWasher, Cleaner, Automated, Endoscope1decision

Whose devices does it build on?

Its devices cite 5 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 2 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.

  • K043314Manzi Cleaner SystemLangford IC Systems, Inc. · 20052cite it
  • K060458Manzi Mach 1 Instrument Cleaner-Processor System, Manzi Detergent MD10, Manzi Sterilant MS10, Manzi Chemical…Langford IC Systems, Inc. · 20061cites it

What has FDA decided for it lately?

  • K101158Lic Instrument Processing SystemLangford IC Systems, Inc. · 2011
  • K060458Manzi Mach 1 Instrument Cleaner-Processor System, Manzi Detergent MD10, Manzi Sterilant MS10, Manzi Chemical…Langford IC Systems, Inc. · 2006
  • K043314Manzi Cleaner SystemLangford IC Systems, Inc. · 2005

All 3 as Langford IC Systems, Inc. →