510(k) Report

FDA applicant

Dutton-Lainson Co.

Hastings, NE3 decisions1993–19940 recalls

FDA records 3 decisions for Dutton-Lainson Co. (Hastings, NE) from 1993 to 1994: 3 510(k) clearances. Most are in product codes ILJ (Bath, Hydro-Massage) and FSA (Lift, Patient, Non-Ac-Powered). 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 Dutton-Lainson Co.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Dutton-Lainson Co. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Dutton-Lainson Co. 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?

  • ILJBath, Hydro-Massage1decision
  • FSALift, Patient, Non-Ac-Powered1decision
  • FRWScale, Patient1decision

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.

  • K930624Sanitas Whirpool Bathing SystemDutton-Lainson Co. · 19941cites it

What has FDA decided for it lately?

  • K930624Sanitas Whirpool Bathing SystemDutton-Lainson Co. · 1994
  • K930625Sanitas Patient LiftDutton-Lainson Co. · 1993
  • K930626Sanitas Patient ScaleDutton-Lainson Co. · 1993

All 3 as Dutton-Lainson Co. →