510(k) Report

FDA applicant

Primed, Inc.

Manchester, NH1 decision1994–19940 recalls

FDA records 1 decision for Primed, Inc. (Manchester, NH) in 1994: 1 510(k) clearance. All are in product code KCT (Sterilization Wrap Containers, Trays…). 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 Primed, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Primed, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Primed, 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?

  • KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories1decision

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.

  • K944864Primed Rigid Container SystemPrimed, Inc. · 19942cite it

What has FDA decided for it lately?

  • K944864Primed Rigid Container SystemPrimed, Inc. · 1994

The one decision as Primed, Inc. →

Other applicant names beginning “Primed”

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

Primed Medical Products, Inc. 10Primed Halberstadt Medizintechnik GmbH 1Primed Instruments, Inc. 1Primed Products, Inc. 1