510(k) Report

FDA applicant

Medicult A/S

San Diego, CA26 decisions2000–20081 recall

FDA records 26 decisions for Medicult A/S (San Diego, CA) from 2000 to 2008: 26 510(k) clearances. All are in product code MQL (Media, Reproductive). Its devices cite 17 predicates, 12 of them its own earlier devices. 1 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 Medicult A/S’s devices, and how often a recall has named them.

FDA decisions per year

3in 2008

2007: 12008: 3
2007high 3 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

1in 2022

2022: 1
2007high 1 (2022) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Medicult A/S by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MQLMedia, Reproductive26decisions

Whose devices does it build on?

Its devices cite 17 predicates; 12 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 22 times; 12 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.

  • K991279Medi-Cult Universal Ivf-MediumMedicult A/S · 20003cite it
  • K031228Synvitro HyadaseMedicult A/S · 20032cite it
  • K003156Blastassist SystemMedicult A/S · 20012cite it
  • K991334Medi-Cult Hyaluronidase;Medicult A/S · 20002cite it
  • K080172Blastassist Without Phenol Red, Model Ref 1215, Blastassist with Phenol Red, Model Ref 1216Medicult A/S · 20081cites it
  • K080473Embryoassist and Embryoassist with Phenol RedMedicult A/S · 20081cites it

What has FDA decided for it lately?

  • K080172Blastassist Without Phenol Red, Model Ref 1215, Blastassist with Phenol Red, Model Ref 1216Medicult A/S · 2008
  • K081639Icsi CumulaseMedicult A/S · 2008
  • K080473Embryoassist and Embryoassist with Phenol RedMedicult A/S · 2008
  • K061309EmbryoassistMedicult A/S · 2007
  • K061145SpermslowMedicult A/S · 2006
  • K060983Biopsy Medium, Model Ref 1062Medicult A/S · 20061 recall
  • K060699Synvitro Cumulase (Hyaluronidase Medium)Medicult A/S · 2006
  • K041284Medicult Ivm SystemMedicult A/S · 2004

All 26 as Medicult A/S →

What has been recalled?

1 recall linked to its devices; the latest:

  • K060983BIOPSY MEDIUM 10ML, Reference Number 10620010 A, used for blastomere biopsy of cleavage…Dec 15, 2022Class II