510(k) Report

FDA product code · Pathology

System, Microarray-Based, Genome-Wide, Postnatal Chromosomal Abnormality Detection

PFXClass II21 CFR 866.5920510(k) required2 decisions since 20140 recalls

2 FDA decisions since 2014. No recall names this code. The most-cited predicate is DEN130018, named by 1 later device.

A microarray-based, genome-wide, postnatal chromosomal abnormality detection system is used to qualitatively detect constitutional gains and losses in chromosomal copy numbers across the human genome using microarray methods. It is intended as an aid in the postnatal diagnosis of developmental delay and/or intellectual disability (DD/ID), congenital anomalies, and dysmorphic features in conjunction with other…

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, pathology panel

Twenty years of PFX 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 · PFX

1in 2017

2014: 12017: 1
2007high 1 (2014) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PFX

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

Recalls per year · PFX

No recall names PFX since 2007.

Adverse event reports per year · PFX

2in 2025

2025: 2
2007high 2 (2025) · low 0 (2007)2025

MAUDE reports naming product code PFX, 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
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20141—00
20150—00
20160—00
20171—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—02
20260—0—
FIG. 1 — PFX by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in PFX? 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

Which predicates do PFX devices cite most?

Devices in this code that later submissions most often claim equivalence to.

  • DEN130018Cytoscan (R) DXAffymetrix, Inc. · 20141cites it

Which PFX devices have the deepest lineage?

Devices in this code with the longest line of descent behind them.

  • K163367GenetiSure Dx Postnatal AssayAgilent Technologies, Inc. · 20171generation

What has FDA decided in PFX lately?

  • K163367GenetiSure Dx Postnatal AssayAgilent Technologies, Inc. · 20171 recall
  • DEN130018Cytoscan (R) DXAffymetrix, Inc. · 2014

All 2 PFX decisions →