510(k) Report

FDA applicant

Origio A/S

Måløv, DK14 decisions2010–20205 recalls

FDA records 14 decisions for Origio A/S (Måløv, DK) from 2010 to 2020: 14 510(k) clearances. Most are in product codes MQL (Media, Reproductive) and MQK (Labware, Assisted Reproduction). Since 2016 its 510(k)s took a median of 123 days from receipt to decision, against 162 for FDA’s reviews in the same codes and years. Its devices cite 15 predicates, 4 of them its own earlier devices. 5 recalls are 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 Origio A/S’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2010: 12012: 12014: 42016: 22017: 32018: 22020: 1
2010high 4 (2014) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

3in 2024

2020: 12022: 12024: 3
2010high 3 (2024) · low 0 (2010)2026

Class I Class II/III not classified

FIG. 1 — Origio A/S by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MQLMedia, Reproductive10decisions
  • MQKLabware, Assisted Reproduction3decisions
  • MQFCatheter, Assisted Reproduction1decision

How long do its 510(k) reviews take?

Since 2016, its 6 510(k)s took a median of 123 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 162 days; 3 of its 6 were faster than that.

Whose devices does it build on?

Its devices cite 15 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 8 times; 4 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.

  • K200815VitriGuardOrigio A/S · 20202cite it
  • K133707Sage 1-Step with Human Serum Albumin, Sage 1-Step with Serum Protein SupplementsOrigio A/S · 20142cite it
  • K153267ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm WashOrigio A/S · 20161cites it
  • K133387Origio (R) Sequential Blast TM; Origio (R) Sequential Blast TM with Phenol RedOrigio A/S · 20141cites it
  • K120136EmbryogenOrigio A/S · 20121cites it
  • K162833VitriGuardOrigio A/S · 20171cites it

What has FDA decided for it lately?

  • K200815VitriGuardOrigio A/S · 2020
  • K180740VitriGuardOrigio A/S · 2018
  • K173624ORIGIO® Handling™ without phenol red (Cat. No. 8310), ORIGIO® Handling™ with phenol red (Cat. No. 8311)Origio A/S · 2018
  • K172197SAGE 1-Step GM-CSF with HSA, SAGE 1-Step GM-CSF with SPSOrigio A/S · 2017
  • K161547Transem and EchoGen Embryo Transfer CathetersOrigio A/S · 2017
  • K162833VitriGuardOrigio A/S · 20171 recall
  • K153267ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm WashOrigio A/S · 20163 recalls
  • K152932BlastGenOrigio A/S · 2016

All 14 as Origio A/S →

What has been recalled?

5 recalls linked to its devices; the latest:

  • K153267Origio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of…Feb 16, 2024Class II
  • K153267Origio Sperm Wash Medium Pack of Ten 10ml bottles - Intended for washing of spermatozoa…Feb 16, 2024Class II
  • K153267Origio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of…Feb 16, 2024Class II
  • K162833VITRIGUARD, CARRIER, CLEAR; Model. No. 43782001 The VitriGuard device is a…Apr 1, 2022Class II
  • K100367MediCult Vitrification Cooling Media, Model Number 12284001FSep 8, 2020Class II

Other applicant names beginning “Origio”

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

Origio, Inc. 1Origio A/S, A Coopersurgical Company 1