510(k) Report

510(k) · Cleared

Cleared

Embryoassist and Embryoassist with Phenol Red

K080473510(k) TraditionalCleared Sep 3, 2008195-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

Medicult A/S · MQL Media, Reproductive

Cleared on Sep 3, 2008 as substantially equivalent to K991279 (Medicult A/S, 2000) and 2 other predicates after a 195-day review. Its family tree reaches back 2 generations to 2000. 2 later devices descend from it.

Decided
Sep 3, 2008
Review
195 days
Class
Class II
Product code
MQL
Recalls
None
Predicates
3

Its longest line of descent runs back 2 generations to K000625 (2000). 6 ancestors in all. 2 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2007: 1 other ancestor2000: 2 other ancestors2001: 1 other ancestor2012: 1 descendant cleared2014: 1 descendant clearedK000625 · Scandinavian Ivf Sciences AB, G1.2 · Vitrolife AB/Scandinavian Ivf Sciences AB · 2000K030490 · ISM1+, IMS2+, and Utm+ · Medicult A/S · 2003200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 2 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant K030490 · ISM1+, IMS2+, and Utm+ · Medicult A/S · 2003K000625 · Scandinavian Ivf Sciences AB, G1.2 · Vitrolife AB/Scandinavian Ivf Sciences AB · 20000
  1. Root · 2 generations backK000625 Scandinavian Ivf Sciences AB, G1.2Vitrolife AB/Scandinavian Ivf Sciences AB · 2000
  2. 1 generation backK030490 ISM1+, IMS2+, and Utm+Medicult A/S · 2003
  3. This deviceK080473 Embryoassist and Embryoassist with Phenol RedMedicult A/S · 2008
  4. Descendant · cites it directly · 1 of its ownK120136 EmbryogenOrigio A/S · 2012
  5. Descendant · 2 generations on · 0 of its ownK140317 EmbryogenOrigio A/S · 2014

Most influential descendants

Showing 2 of 2 · See all
  • K120136EmbryogenOrigio A/S · 2012 · cites it directly1descendant
  • K140317EmbryogenOrigio A/S · 2014 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K000625Scandinavian Ivf Sciences AB, G1.2Vitrolife AB/Scandinavian Ivf Sciences AB2000—
−1K030490ISM1+, IMS2+, and Utm+Medicult A/S2003—
0 (this device)K080473Embryoassist and Embryoassist with Phenol RedMedicult A/S2008—
+1K120136EmbryogenOrigio A/S2012—
+2K140317EmbryogenOrigio A/S2014—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200020
200110
200710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201410
FIG. 1 — Lineage of K080473, 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? (3)

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
*K991279Medi-Cult Universal Ivf-Medium
Summary page 1
…TMand EmbryoAssist TMwith Phenol Red Classification name: Reproductive media and supplements (21 CFR 884.6180, Product Code MQL) Predicate device: Universal IVF Medium (K991279), EmbryoAssist TM (K061309) and ISMlTM (K030490) from MediCult. Description EmbryoAssist T M and EmbryoAssist TM with Phenol Red…
Medicult A/S2000—
*K061309Embryoassist
Summary page 1
…henol Red Classification name: Reproductive media and supplements (21 CFR 884.6180, Product Code MQL) Predicate device: Universal IVF Medium (K991279), EmbryoAssist TM (K061309) and ISMlTM (K030490) from MediCult. Description EmbryoAssist T M and EmbryoAssist TM with Phenol Red are each a defined sterile…
Medicult A/S2007—
*K030490ISM1+, IMS2+, and Utm+
Summary page 1
…ion name: Reproductive media and supplements (21 CFR 884.6180, Product Code MQL) Predicate device: Universal IVF Medium (K991279), EmbryoAssist TM (K061309) and ISMlTM (K030490) from MediCult. Description EmbryoAssist T M and EmbryoAssist TM with Phenol Red are each a defined sterile media used by profes…
Medicult A/S2003—

Also cleared against K991279: 2 other devices →

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K120136EmbryogenOrigio A/S20121

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?

  • The line of descent spans 8 years and passes through 2 companies; a new generation was cleared every 5.0 years on median.
  • None of the 6 ancestors has a recall.
  • Of its descendants, K120136 (Origio A/S, 2012) has gone furthest, with 1 descendant of its own.
  • 2 other devices also cite its predicate K991279.

How does its category compare?

All MQL devices

MQL Media, Reproductive: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?

EmbryoAssist TM with Phenol Red is for fertilization and culture until the 2-8 cell stage.

EmbryoAssist TM with Phenol Red can also be used for embryo transfer at day 2 or 3.

EmbryoAssist TM is for fertilization and culture until the 2-8 cell stage.

EmbryoAssist TM can also be used for embryo transfer at day 2 or 3.

Indications for use as stated in the FDA summary.

Also cleared against K991279

2 other devices cite the same predicate.

  • K061309EmbryoassistMedicult A/S · 2007
  • K041284Medicult Ivm SystemMedicult A/S · 2004

More from Medicult A/S

26 FDA decisions under this applicant name. See the company

  • K080172Blastassist Without Phenol Red, Model Ref 1215, Blastassist with Phenol Red, Model Ref 1216Medicult A/S · 2008
  • K081639Icsi CumulaseMedicult A/S · 2008
  • K061309EmbryoassistMedicult A/S · 2007
  • K061145SpermslowMedicult A/S · 2006
  • K060983Biopsy Medium, Model Ref 1062Medicult A/S · 20061 recall

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/K080473 · printed Nov 6, 2026

Cite this page

510(k) Report. “K080473: Embryoassist and Embryoassist with Phenol Red.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080473

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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