FDA product code · Obstetrics and gynecology

System, Assisted Reproduction Laser

Name: FDA decisions, review times, recalls and adverse event reports for product code MRX
Creator: 510(k) Report

MRXClass II21 CFR 884.6200510(k) required11 decisions since 20040 recalls

11 FDA decisions since 2004. 510(k) reviews decided 2021–2025 took a median of 326 days (half between 326 and 326). No recall names this code. The most-cited predicate is K060764, named by 3 later devices.

This system is inteded to be used to drill a small tangential hole in or to thin the zona pellucida of the embryo in selected in vitro fertilization patients with otherwise poor prognois for successful pregnancy outcome, such as advanced maternal age, prior failed in vitro fertilization procedures, cryopreserved embryos, or abnormal zona pellucida morphology.

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

FIG. A — Illustration, obstetrics and gynecology panel

Twenty years of MRX at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · MRX

1in 2021

2007high 2 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MRX

Too few MRX 510(k)s in any year since 2007 to give a median.

Recalls per year · MRX

No recall names MRX since 2007.

Adverse event reports per year · MRX

No MAUDE report names MRX since 2007.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	2	—	0
2008	0	—	0
2009	1	—	0
2010	0	—	0
2011	0	—	0
2012	1	—	0
2013	0	—	0
2014	0	—	0
2015	1	—	0
2016	0	—	0
2017	0	—	0
2018	0	—	0
2019	0	—	0
2020	1	—	0
2021	1	—	0
2022	0	—	0
2023	0	—	0
2024	0	—	0
2025	0	—	0
2026	1	—	—

FIG. 1 — MRX by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in MRX? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

System, Assisted Reproduction Laser

Which predicates do MRX devices cite most?

Which MRX devices have the deepest lineage?

What has FDA decided in MRX lately?