510(k) · Cleared

Cleared

Blastassist Without Phenol Red, Model Ref 1215, Blastassist with Phenol Red, Model Ref 1216

K080172510(k) TraditionalCleared Dec 18, 2008329-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 Dec 18, 2008 as substantially equivalent to K003156 (Medicult A/S, 2001) after a 329-day review. Its family tree reaches back 1 generation to 2001. 2 later devices descend from it.

Decided: Dec 18, 2008
Review: 329 days
Class: Class II
Product code: MQL
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K003156 (2001). 2 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK003156 Blastassist SystemMedicult A/S · 2001
This deviceK080172 Blastassist Without Phenol Red, Model Ref 1215, Blastassist with…Medicult A/S · 2008
Descendant · cites it directly · 1 of its ownK133387 Origio (R) Sequential Blast TM; Origio (R) Sequential Blast TM with…Origio A/S · 2014
Descendant · 2 generations on · 0 of its ownK152932 BlastGenOrigio A/S · 2016

Most influential descendants

Showing 2 of 2 · See all

K133387Origio (R) Sequential Blast TM; Origio (R) Sequential Blast TM with Phenol RedOrigio A/S · 2014 · cites it directly1descendant
K152932BlastGenOrigio A/S · 2016 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K003156	Blastassist System	Medicult A/S	2001	—
0 (this device)	K080172	Blastassist Without Phenol Red, Model Ref 1215, Blastassist with Phenol Red…	Medicult A/S	2008	—
+1	K133387	Origio (R) Sequential Blast TM; Origio (R) Sequential Blast TM with Phenol Red	Origio A/S	2014	—
+2	K152932	BlastGen	Origio A/S	2016	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2014	1	0
2016	1	0

FIG. 1 — Lineage of K080172, 2001–2016Source: 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

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K003156	Blastassist System Summary page 1 …ssist® and BlastAsist® with Phenol Red Classification name: Reproductive media and supplements (21 CFR 884.6180, Product Code MQL) Predicate device: BlastAssist®System (K003156) from MediCult. Description BlastAssist® and BlastAssist® with Phenol Red are defined sterile media, used by assisted reproducti…	Medicult A/S	2001	—

Also cleared against K003156: 1 other device →

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K133387	Origio (R) Sequential Blast TM; Origio (R) Sequential Blast TM with Phenol Red	Origio A/S	2014	1

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, K133387 (Origio A/S, 2014) has gone furthest, with 1 descendant of its own.
1 other device also cites its predicate K003156.

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

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?

BlastAssist® is for culture from the 4-8 cell stage through to blastocyst stage. Can also be used for embryo transfer.

BlastAssist® with Phenol Red is for culture from the 4-8 cell stage through to blastocyst stage. Can also be used for embryo transfer.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K080172 · printed Nov 6, 2026

Cite this page

510(k) Report. “K080172: Blastassist Without Phenol Red, Model Ref 1215, Blastassist with Phenol Red, Model Ref 1216.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080172

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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