510(k) Report

FDA applicant

Unisis Corp.

Richardson, TX2 decisions2014–20150 recalls

FDA records 2 decisions for Unisis Corp. (Richardson, TX) from 2014 to 2015: 2 510(k) clearances. All are in product code BSP (Needle, Conduction, Anesthetic (W/Wo Introducer)). Its devices cite 7 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, anesthesiology panel, where it files most

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

FDA decisions per year

1in 2015

2014: 12015: 1
2014high 1 (2014) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Unisis Corp. by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • BSPNeedle, Conduction, Anesthetic (W/Wo Introducer)2decisions

Whose devices does it build on?

Its devices cite 7 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.

  • K141126Uniever Disposable Spinal Anesthesia NeedleUnisis Corp. · 20141cites it
  • K142553UNIEVER Disposable Epidural Anesthesia Needle, UNIEVER Disposable Nerve Blocked NeedleUnisis Corp. · 20151cites it

What has FDA decided for it lately?

  • K142553UNIEVER Disposable Epidural Anesthesia Needle, UNIEVER Disposable Nerve Blocked NeedleUnisis Corp. · 2015
  • K141126Uniever Disposable Spinal Anesthesia NeedleUnisis Corp. · 2014

All 2 as Unisis Corp. →