510(k) Report

FDA applicant

Vitrolife A/S

Viby J, DK4 decisions2015–20220 recalls

FDA records 4 decisions for Vitrolife A/S (Viby J, DK) from 2015 to 2022: 4 510(k) clearances. Most are in product codes MQK (Labware, Assisted Reproduction) and PBH (Embryo Image Assessment System, Assisted…). Its devices cite 5 predicates, 2 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, obstetrics and gynecology panel, where it files most

How often FDA has decided Vitrolife A/S’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2015: 12018: 12019: 12022: 1
2015high 1 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Vitrolife A/S by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MQKLabware, Assisted Reproduction2decisions
  • PBHEmbryo Image Assessment System, Assisted Reproduction1decision
  • MQGAccessory, Assisted Reproduction1decision

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 4 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.

  • K173264EmbryoScope+Vitrolife A/S · 20183cite it
  • K150961EmbryoSlide Culture DishVitrolife A/S · 20151cites it

What has FDA decided for it lately?

  • K213869EmbryoSlide+ ic8 dishVitrolife A/S · 2022
  • K182798KIDScore D3Vitrolife A/S · 2019
  • K173264EmbryoScope+Vitrolife A/S · 2018
  • K150961EmbryoSlide Culture DishVitrolife A/S · 2015

All 4 as Vitrolife A/S →

Other applicant names beginning “Vitrolife”

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

Vitrolife Sweden AB 38Vitrolife AB/Scandinavian Ivf Sciences AB 7Vitrolife AB 5