510(k) Report

FDA applicant

Inviro Medical

Laguna Niguel, CA2 decisions2003–20040 recalls

FDA records 2 decisions for Inviro Medical (Laguna Niguel, CA) from 2003 to 2004: 2 510(k) clearances. All are in product code MEG (Syringe, Antistick). Its devices cite 3 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, general hospital panel, where it files most

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

FDA decisions per year

No FDA decision for Inviro Medical since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Inviro Medical 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?

  • MEGSyringe, Antistick2decisions

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 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.

  • K032780Inviro Snap Safety Syringe, 1CC, 3CC, 5CC, and 10CCInviro Medical · 20032cite it
  • K040036Inviro Snap Safety Insulin Syringe, 1 CC, Model 102905Inviro Medical · 20042cite it

What has FDA decided for it lately?

  • K040036Inviro Snap Safety Insulin Syringe, 1 CC, Model 102905Inviro Medical · 2004
  • K032780Inviro Snap Safety Syringe, 1CC, 3CC, 5CC, and 10CCInviro Medical · 2003

All 2 as Inviro Medical →

Other applicant names beginning “Inviro”

FDA records each applicant name separately; these may or may not be the same firm.

Inviro Medical Devices, Inc. 7