510(k) Report

510(k) · Cleared

Cleared

Origio Sequential Fert, Origio Sequential Fert with Phenol Red, Origio Sequential Cleav, Origio Sequential Cleav, Origio

K133912510(k) TraditionalCleared May 14, 2014142-day reviewClass II21 CFR 884.6180

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Origio A/S · MQL Media, Reproductive

Cleared on May 14, 2014 as substantially equivalent to K002385 (Cook Ob/Gyn, 2000) after a 142-day review. Its family tree reaches back 1 generation to 2000.

Decided
May 14, 2014
Review
142 days
Class
Class II
Product code
MQL
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K002385 (2000). No later device cites it as a predicate yet.

Reference device: K080473 · Embryoassist and Embryoassist with Phenol Red · Medicult A/S · 2008Reference device: K120136 · Embryogen · Origio A/S · 2012Reference device: K030490 · ISM1+, IMS2+, and Utm+ · Medicult A/S · 2003Reference device: K133707 · Sage 1-Step with Human Serum Albumin, Sage 1-Step with Serum Protein Supplements · Origio A/S · 2014Reference device: K991279 · Medi-Cult Universal Ivf-Medium · Medicult A/S · 2000K002385 · Cook Ivf Follicle Flushing Buffer, Cook Ivf Oocyte Wash Buffer, Cook Ivf Fertilization Medium, Cook Ivf Cleavage Medium, · Cook Ob/Gyn · 20002000200520102015
K002385 · Cook Ivf Follicle Flushing Buffer, Cook Ivf Oocyte Wash Buffer, Cook Ivf Fertilization Medium, Cook Ivf Cleavage Medium, · Cook Ob/Gyn · 20000
  1. Root · 1 generation backK002385 Cook Ivf Follicle Flushing Buffer, Cook Ivf Oocyte Wash Buffer, Cook…Cook Ob/Gyn · 2000
  2. This deviceK133912 Origio Sequential Fert, Origio Sequential Fert with Phenol Red…Origio A/S · 2014
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K002385Cook Ivf Follicle Flushing Buffer, Cook Ivf Oocyte Wash Buffer, Cook Ivf…Cook Ob/Gyn2000—
0 (this device)K133912Origio Sequential Fert, Origio Sequential Fert with Phenol Red, Origio…Origio A/S2014—
FIG. 1 — Lineage of K133912, 2000–2014Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in MQL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new MQL device

  1. #1 K251305 Ultra-Fast Vitri; Ultra-Fast Warmscore 14.4 · 6 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K002385Cook Ivf Follicle Flushing Buffer, Cook Ivf Oocyte Wash Buffer, Cook Ivf Fertilization…
Summary page 1
…Code MOL) Predicate devices: Cook Medical: Cook IVF Fertilization Medium and Cook IVF Cleavage Medium (K002385). Description ORIGIC® Sequential FertTM is intended for in vitro fertilization of human oocytes. Two versions of ORIGIQ@ Sequen…
Cook Ob/Gyn2000—
†K080473Embryoassist and Embryoassist with Phenol RedMedicult A/S2008—
†K120136EmbryogenOrigio A/S2012—
†K030490ISM1+, IMS2+, and Utm+Medicult A/S2003—
†K133707Sage 1-Step with Human Serum Albumin, Sage 1-Step with Serum Protein SupplementsOrigio A/S2014—
†K991279Medi-Cult Universal Ivf-MediumMedicult A/S2000—

Also cleared against K002385: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.
  • 2 other devices also cite its predicate K002385.

How does its category compare?

All MQL devices

MQL Media, Reproductive: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.

FDA decisions per year · MQL

9in 2025

2007: 32008: 122009: 22010: 62011: 12012: 52014: 52015: 72016: 122017: 102018: 42019: 62020: 82021: 12022: 32023: 52024: 122025: 92026 (partial year): 3
2007high 12 (2008) · low 0 (2013)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MQL

225in 2025

2007: 212 days median2008: 151 days median2010: 235 days median2012: 253 days median2014: 142 days median2015: 87 days median2016: 170 days median2017: 113 days median2018: 94 days median2019: 170 days median2020: 257 days median2022: 316 days median2023: 199 days median2024: 195 days median2025: 225 days median2026 (partial year): 179 days median
2007high 316 (2022) · low 87 (2015)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MQL

1in 2023

2012: 12020: 12021: 22022: 12023: 1
2007high 2 (2021) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MQL

3in 2025

2012: 12013: 22014: 32016: 22023: 12024: 62025: 3
2007high 6 (2024) · low 0 (2007)2025

MAUDE reports naming product code MQL, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007321200
20081215100
20092—00
2010623500
20111—00
2012525311
20130—02
2014514203
201578700
20161217002
20171011300
201849400
2019617000
2020825710
20211—20
2022331610
2023519911
20241219506
2025922503
202631790—

What is it indicated for?

ORIGIO® Sequential FertTM is for the fertilization of oocytes in vitro.

ORIGIO® Sequential CleavTM is for the culture of embryos until the 2-8 cell stage.

ORIGIO® Sequential CleavTM can also be used for embryo transfer at day 2 or 3.

Indications for use as stated in the FDA summary.

Also cleared against K002385

2 other devices cite the same predicate.

  • K170498Gems Oocyte Retrieval Buffer ORB-20, ORB-50Genea Biomedx Pty, Ltd. · 2017
  • K153290Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium, Sydney IVF Cleavage Medium, Sydney IVF…William A. Cook Australia Pty., Ltd. · 2016

More from Origio A/S

14 FDA decisions under this applicant name. See the company

  • 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

Recent decisions in MQL

The MQL category page

  • K254261Vitrification Freeze Kit and Thawing Kit (CS-IVF-FK; CS-IVF-TK)Cell Store (Beijing) Biotechnology CO., LTD. · 2026
  • K260248Ultra-Fast WarmKitazato Corporation · 2026
  • K252672CaseBio™ Culture w/HSA (CMH5); CaseBio™ Handling w/HSA (WHH5)Casebioscience, Inc. · 2026
  • K250445Fast Warm - NXFujifilm Irvine Scientific · 2025
  • K251637Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle Flushing Solution…Donnevie Medical Technology (Shanghai) Co., Ltd. · 2025

https://510kreport.com/device/K133912 · printed Nov 6, 2026

Cite this page

510(k) Report. “K133912: Origio Sequential Fert, Origio Sequential Fert with Phenol Red, Origio Sequential Cleav, Origio Sequential Cleav, Origio.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133912

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026