510(k) Report

FDA applicant

California Institute of Tissue Eng. & Instrumenti

Visalia, CA1 decision1998–19980 recalls

FDA records 1 decision for California Institute of Tissue Eng. & Instrumenti (Visalia, CA) in 1998: 1 510(k) clearance. All are in product code LFL (Instrument, Ultrasonic Surgical). 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

How often FDA has decided California Institute of Tissue Eng. & Instrumenti’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for California Institute of Tissue Eng. & Instrumenti since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — California Institute of Tissue Eng. & Instrumenti by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LFLInstrument, Ultrasonic Surgical1decision

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K980895Allegro Ultrasonic Soft Tissue AspiratorCalifornia Institute of Tissue Eng. & Instrumenti · 1998

The one decision as California Institute of Tissue Eng. & Instrumenti →