510(k) Report

FDA applicant

Immuno-U.S., Inc.

Rockville, MD1 decision1997–19970 recalls

FDA records 1 decision for Immuno-U.S., Inc. (Rockville, MD) in 1997: 1 510(k) clearance. All are in product code FMF (Syringe, Piston). 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 Immuno-U.S., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Immuno-U.S., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Immuno-U.S., Inc. 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?

  • FMFSyringe, Piston1decision

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.

  • K973510Duploject (0.5/1.0 ML, 2.0 ML, 5.0 ML)Immuno-U.S., Inc. · 19974cite it

What has FDA decided for it lately?

  • K973510Duploject (0.5/1.0 ML, 2.0 ML, 5.0 ML)Immuno-U.S., Inc. · 1997

The one decision as Immuno-U.S., Inc. →

Other applicant names beginning “Immuno-U.S.”

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

Immuno Concepts, Inc. 36Immuno Nuclear Corp. 30Immuno-Mycologics, Inc. 26Immuno-Products Industries 12Immuno Assay Corp. 10Immuno-Diagnostic Products, Inc. 8Immuno Concepts, N.A., Ltd. 4Immuno Diagnostic Center, Inc. 3Immuno-Diagnostic Laboratories 2Immuno Pathology Labs 1