510(k) Report

FDA applicant

Mesi D.O.O.; Mesi, Development of Medical Devices, Ltd.

Ljubljana, SI2 decisions2018–20200 recalls

FDA records 2 decisions for Mesi D.O.O.; Mesi, Development of Medical Devices, Ltd. (Ljubljana, SI) from 2018 to 2020: 2 510(k) clearances. All are in product code JOM (Plethysmograph, Photoelectric, Pneumatic Or…). Its devices cite 2 predicates, 1 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, cardiovascular panel, where it files most

How often FDA has decided Mesi D.O.O.; Mesi, Development of Medical Devices, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2018: 12020: 1
2018high 1 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Mesi D.O.O.; Mesi, Development of Medical Devices, Ltd. by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • JOMPlethysmograph, Photoelectric, Pneumatic Or Hydraulic2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 1 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.

  • K172655Automated ankle brachial pressure index measuring deviceMesi D.O.O.; Mesi, Development of Medical Devices, Ltd. · 20182cite it

What has FDA decided for it lately?

  • K201046Automated ankle brachial pressure index measuring device, MESI mTABLET systemMesi D.O.O.; Mesi, Development of Medical Devices, Ltd. · 2020
  • K172655Automated ankle brachial pressure index measuring deviceMesi D.O.O.; Mesi, Development of Medical Devices, Ltd. · 2018

All 2 as Mesi D.O.O.; Mesi, Development of Medical Devices, Ltd. →

Other applicant names beginning “Mesi”

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

Mesi, Development of Medical Devices, Ltd.; Mesi D.O.O. 2Mesi D.O.O. 1