510(k) Report

FDA applicant

Hertart

Västra Frölunda, SE3 decisions2013–20200 recalls

FDA records 3 decisions for Hertart (Västra Frölunda, SE) from 2013 to 2020: 3 510(k) clearances. All are in product code MQK (Labware, Assisted Reproduction). Its devices cite 7 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Hertart Aps”.

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 Hertart’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2013: 12015: 12020: 1
2013high 1 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Hertart by year, 2013–2026Sources: 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 Reproduction3decisions

Whose devices does it build on?

Its devices cite 7 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K123641Culture Dish 40 MM, Culture Dish 60 MM, Micro Droplet Culture Dish, 5 Well Culture Dish, Centre Well Dish…Hertart · 20131cites it

What has FDA decided for it lately?

  • K201213Pasteur Pipette 3mL, Pasteur Pipette 1mLHertart Aps · 2020
  • K150756Micro well group culture dish, 9-well; Micro well group culture dish, 16-wellHertart · 2015
  • K123641Culture Dish 40 MM, Culture Dish 60 MM, Micro Droplet Culture Dish, 5 Well Culture Dish, Centre Well Dish…Hertart · 2013

All 2 as Hertart →The one decision as Hertart Aps →