510(k) · Cleared

Cleared

Medicult Ivm System

K041284510(k) TraditionalCleared Nov 22, 2004193-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 Nov 22, 2004 as substantially equivalent to K991279 (Medicult A/S, 2000) after a 193-day review. Its family tree reaches back 1 generation to 2000. 1 later device descends from it.

Decided: Nov 22, 2004
Review: 193 days
Class: Class II
Product code: MQL
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K991279 (2000). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK991279 Medi-Cult Universal Ivf-MediumMedicult A/S · 2000
This deviceK041284 Medicult Ivm SystemMedicult A/S · 2004
Descendant · cites it directly · 0 of its ownK053646 Invitro Maturation MediaSage In-Vitro Fertilization, Inc. · 2006

Most influential descendants

Showing 1 of 1 · See all

K053646Invitro Maturation MediaSage In-Vitro Fertilization, Inc. · 2006 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K991279	Medi-Cult Universal Ivf-Medium	Medicult A/S	2000	—
0 (this device)	K041284	Medicult Ivm System	Medicult A/S	2004	—
+1	K053646	Invitro Maturation Media	Sage In-Vitro Fertilization, Inc.	2006	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0

FIG. 1 — Lineage of K041284, 2000–2006Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 K251305 Ultra-Fast Vitri; Ultra-Fast Warmscore 14.4 · 6 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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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.

Type	Number	Device	Applicant	Decided	Recalls
*	K991279	Medi-Cult Universal Ivf-Medium Summary page 1 …serum albumin. MediCult IVM®System is indicated for pre-incubation and maturing of immature oocytes and is substantially equivalent to MediCult's Universal IVF Medium (K 991279) indicated for preparation of mature oocytes. The MediCult IVM®System has been tested in two studies by Prof. Svend Lindenberg a…	Medicult A/S	2000	—

Also cleared against K991279: 2 other devices →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K053646	Invitro Maturation Media	Sage In-Vitro Fertilization, Inc.	2006	0

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.
Of its descendants, K053646 (Sage In-Vitro Fertilization, Inc., 2006) has gone furthest, with 0 descendants 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.

FDA decisions per year · MQL

9in 2025

2007high 12 (2008) · low 0 (2013)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MQL

225in 2025

2007high 316 (2022) · low 87 (2015)2026

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

Recalls per year · MQL

1in 2023

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	3	212	0	0
2008	12	151	0	0
2009	2	—	0	0
2010	6	235	0	0
2011	1	—	0	0
2012	5	253	1	1
2013	0	—	0	2
2014	5	142	0	3
2015	7	87	0	0
2016	12	170	0	2
2017	10	113	0	0
2018	4	94	0	0
2019	6	170	0	0
2020	8	257	1	0
2021	1	—	2	0
2022	3	316	1	0
2023	5	199	1	1
2024	12	195	0	6
2025	9	225	0	3
2026	3	179	0	—

What is it indicated for?

Vial 1: The LAG Medium is for pre-incubation of immature oocytes.

Vial 2: IVM® Medium is a basal medium for maturing immature oocytes with supplements

"The LAG medium is for pre-incubation of immature oocytes and the IVM Medium is a basal medium for maturing immature oocytes of infertile women undergoing in vitro fertilization who for medical reasons can not undergo conventional ovarian stimulation using drugs."

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K041284 · printed Nov 5, 2026

Cite this page

510(k) Report. “K041284: Medicult Ivm System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041284

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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