510(k) Report

FDA applicant

Dornoch Medical Systems

Riverside, MO6 decisions2008–20190 recalls

FDA records 6 decisions for Dornoch Medical Systems (Riverside, MO) from 2008 to 2019: 6 510(k) clearances. All are in product code JCX (Apparatus, Suction, Ward Use, Portable…). Its devices cite 5 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Dornoch Medical Systems, Inc.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Dornoch Medical Systems’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2008: 12013: 12014: 12016: 12017: 12019: 1
2008high 1 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Dornoch Medical Systems by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Dornoch Medical Systems’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • JCXApparatus, Suction, Ward Use, Portable, Ac-Powered6decisions

Whose devices does it build on?

Its devices cite 5 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 2 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.

  • K081047Transposal Ultra SystemsDornoch Medical Systems, Inc. · 20081cites it
  • K162421IntelliCartTM SystemDornoch Medical Systems · 20161cites it
  • K133786Dornoch Duo Suction Cart with: DL2800 Lid, CL500 Lid, Dornoch Quad Suction Cart with: DL2800 Lid, CL500 LidDornoch Medical Systems, Inc. · 20141cites it

What has FDA decided for it lately?

  • K190789IntelliCartTM SystemDornoch Medical Systems · 2019
  • K172481IntelliCart SystemDornoch Medical Systems · 2017
  • K162421IntelliCartTM SystemDornoch Medical Systems · 2016
  • K133786Dornoch Duo Suction Cart with: DL2800 Lid, CL500 Lid, Dornoch Quad Suction Cart with: DL2800 Lid, CL500 LidDornoch Medical Systems, Inc. · 2014
  • K123188Dornoch Duo Suction Cart with DL2800 Lid Model UL-DU2800, Dornoch Duo Suction Cart with CL500 Lid Model…Dornoch Medical Systems, Inc. · 2013
  • K081047Transposal Ultra SystemsDornoch Medical Systems, Inc. · 2008

All 3 as Dornoch Medical Systems →All 3 as Dornoch Medical Systems, Inc. →