510(k) Report

FDA applicant

Mauna Kea Technologies

Paris, FR19 decisions2005–20220 recalls

FDA records 19 decisions for Mauna Kea Technologies (Paris, FR) from 2005 to 2022: 19 510(k) clearances. Most are in product codes OWN (Confocal Optical Imaging) and GCJ (Laparoscope, General & Plastic Surgery). Since 2016 its 510(k)s took a median of 84 days from receipt to decision, against 84 for FDA’s reviews in the same codes and years. Its devices cite 45 predicates, 29 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Mauna Kea Technologies, Inc.”.

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

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Mauna Kea Technologies’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2011: 12012: 22013: 12014: 22015: 22016: 12017: 22018: 12019: 12020: 22021: 12022: 1
2007high 2 (2012) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Mauna Kea Technologies by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Mauna Kea Technologies’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?

  • OWNConfocal Optical Imaging16decisions
  • GCJLaparoscope, General & Plastic Surgery2decisions
  • GWGEndoscope, Neurological1decision

How long do its 510(k) reviews take?

Since 2016, its 8 510(k)s took a median of 84 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 84 days; 3 of its 8 were faster than that.

Whose devices does it build on?

Its devices cite 45 predicates; 29 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 35 times; 29 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.

  • K111047Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies, Inc. · 20115cite it
  • K123676Cellvizio 100 Series and Cellvizio Systems with Confocal MiniprobesMauna Kea Technologies · 20134cite it
  • K172844Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies · 20173cite it
  • K150831Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies · 20152cite it
  • K120208Cellvizio 100 Series System and Cellvizio System with Confocal MiniprobesMauna Kea Technologies · 20122cite it
  • K183640Cellvizio 100 Series Confocal laser Imaging systems and their Confocal MiniprobesMauna Kea Technologies · 20192cite it

What has FDA decided for it lately?

  • K220477Cellvizio 100 series system with confocal MiniprobesMauna Kea Technologies · 2022
  • K212322Cellvizio I.V.E. system with Confocal MiniprobesMauna Kea Technologies · 2021
  • K193416Cellvizio I.V.E. with Confocal MiniprobesMauna Kea Technologies · 2020
  • K191144Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies · 2020
  • K183640Cellvizio 100 Series Confocal laser Imaging systems and their Confocal MiniprobesMauna Kea Technologies · 2019
  • K180270Cellvizio 100 Series Systems with Confocal MiniprobesMauna Kea Technologies · 2018
  • K172844Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies · 2017
  • K171345Cellvizio 100 Series Systems with Confocal MiniprobesMauna Kea Technologies · 2017

All 18 as Mauna Kea Technologies →The one decision as Mauna Kea Technologies, Inc. →

Other applicant names beginning “Mauna”

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

Mauna Loa Medical, Inc. 2