510(k) Report

FDA applicant

Shl Medical, USA

Florham Park, NJ2 decisions2005–20060 recalls

FDA records 2 decisions for Shl Medical, USA (Florham Park, NJ) from 2005 to 2006: 2 510(k) clearances. All are in product code KZH (Introducer, Syringe Needle). Its devices cite 2 predicates, 1 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, general hospital panel, where it files most

How often FDA has decided Shl Medical, USA’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Shl Medical, USA since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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

See the 510(k) Report

Which product codes does it file in?

  • KZHIntroducer, Syringe Needle2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 1 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.

  • K050434SHL Disposable AutoinjectorShl Medical, USA · 20051cites it
  • K060141DAI-RShl Medical, USA · 20061cites it

What has FDA decided for it lately?

  • K060141DAI-RShl Medical, USA · 2006
  • K050434SHL Disposable AutoinjectorShl Medical, USA · 2005

All 2 as Shl Medical, USA →