510(k) Report

FDA applicant

Manan Medical Devices

Skokie, IL1 decision1988–19880 recalls

FDA records 1 decision for Manan Medical Devices (Skokie, IL) in 1988: 1 510(k) clearance. All are in product code FMI (Needle, Hypodermic, Single Lumen). 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 Manan Medical Devices’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Manan Medical Devices since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Manan Medical Devices 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?

  • FMINeedle, Hypodermic, Single Lumen1decision

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K881671Manan Tabar-Rothschild Galactography KitManan Medical Devices · 19881cites it

What has FDA decided for it lately?

  • K881671Manan Tabar-Rothschild Galactography KitManan Medical Devices · 1988

The one decision as Manan Medical Devices →

Other applicant names beginning “Manan”

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

Manan Medical Products, Inc. 39Manan Manufacturing Co., Inc. 20