510(k) Report

FDA applicant

Pedicraft, Inc.

Jacksonville, FL5 decisions1982–19930 recalls

FDA records 5 decisions for Pedicraft, Inc. (Jacksonville, FL) from 1982 to 1993: 5 510(k) clearances. Most are in product codes FMS (Bed, Pediatric Open Hospital) and FRP (Holder, Infant Position). 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 Pedicraft, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Pedicraft, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Pedicraft, 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?

  • FMSBed, Pediatric Open Hospital3decisions
  • FRPHolder, Infant Position2decisions

Who builds on its devices?

Later devices cite its devices 3 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.

  • K905629Pedicraft Infant Reflux WedgePedicraft, Inc. · 19913cite it

What has FDA decided for it lately?

  • K925817Head & Foot End Drop Pedi-CribPedicraft, Inc. · 1993
  • K925949Pedicragt BassinetPedicraft, Inc. · 1993
  • K905630Infant Reflux SlingPedicraft, Inc. · 1991
  • K905629Pedicraft Infant Reflux WedgePedicraft, Inc. · 1991
  • K821773Pedicraft Bed, Model B2944Pedicraft, Inc. · 1982

All 5 as Pedicraft, Inc. →