510(k) Report

FDA applicant

Innospine, Inc.

Los Altos Hills, CA1 decision2005–20051 recall

FDA records 1 decision for Innospine, Inc. (Los Altos Hills, CA) in 2005: 1 510(k) clearance. All are in product code BSP (Needle, Conduction, Anesthetic (W/Wo Introducer)). Its devices cite 6 predicates, 0 of them its own earlier devices. 1 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, anesthesiology panel, where it files most

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

FDA decisions per year

No FDA decision for Innospine, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Innospine, 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?

  • BSPNeedle, Conduction, Anesthetic (W/Wo Introducer)1decision

Whose devices does it build on?

Its devices cite 6 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 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.

  • K043500Functional Anaesthetic Discography (Fad) System, Including Fad Catheter Kit and Fad Introducer NeedleInnospine, Inc. · 20053cite it

What has FDA decided for it lately?

  • K043500Functional Anaesthetic Discography (Fad) System, Including Fad Catheter Kit and Fad Introducer NeedleInnospine, Inc. · 20051 recall

The one decision as Innospine, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K043500Functional Anaesthetic Discography (F.A.D.) Catheter System, Catalog #: D01A, Kyphon…Apr 25, 2006