510(k) Report

FDA product code · Cardiovascular

Device, Percutaneous Retrieval

MMXClass II21 CFR 870.5150510(k) required32 decisions since 20020 recalls

32 FDA decisions since 2002. 510(k) reviews decided 2021–2025 took a median of 153 days (half between 27 and 251). No recall names this code. The most-cited predicate is K112185, named by 4 later devices.

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, cardiovascular panel

Twenty years of MMX 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 · MMX

1in 2025

2007: 12009: 22010: 12011: 12012: 12014: 22015: 22016: 22017: 22018: 12019: 12020: 22021: 12022: 32023: 22024: 12025: 1
2007high 3 (2022) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MMX

151in 2022

2022: 151 days median
2007high 151 (2022)2026

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

Recalls per year · MMX

No recall names MMX since 2007.

Adverse event reports per year · MMX

49in 2025

2007: 22008: 62009: 62010: 112011: 152012: 132013: 102014: 112015: 52016: 162017: 292018: 152019: 172020: 142021: 222022: 372023: 402024: 322025: 49
2007high 49 (2025) · low 2 (2007)2025

MAUDE reports naming product code MMX, 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
20071—02
20080—06
20092—06
20101—011
20111—015
20121—013
20130—010
20142—011
20152—05
20162—016
20172—029
20181—015
20191—017
20202—014
20211—022
20223151037
20232—040
20241—032
20251—049
20260—0—
FIG. 1 — MMX by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in MMX? 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

Related product codes

Other codes under 21 CFR 870.5150.