510(k) Report

FDA product code · Pathology

System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Mutations & Variants Panel Sequencing Detection

PFRClass II21 CFR 866.5900510(k) required1 decision since 20130 recalls

1 FDA decision since 2013. No recall names this code.

The CFTR gene mutation detection system is used to simultaneously detect and identify a specified panel of mutations and variants in the CFTR gene using sequencing methods. It is intended for carrier screening, as an aid in confirmatory diagnostic testing of individuals with suspected cystic fibrosis (CF), and as an initial test to aid in the diagnosis of individuals with suspected CF. It is not intended for…

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 PFR 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 · PFR

1in 2013

2013: 1
2007high 1 (2013) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PFR

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

Recalls per year · PFR

No recall names PFR since 2007.

Adverse event reports per year · PFR

No MAUDE report names PFR since 2007.

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
20131—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — PFR by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

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

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Which PFR devices have the deepest lineage?

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

  • K124006Illumina Miseqdx Cystic Fibrosis 139-Variant AssayIllumina, Inc. · 20133generations

What has FDA decided in PFR lately?

  • K124006Illumina Miseqdx Cystic Fibrosis 139-Variant AssayIllumina, Inc. · 2013

The one PFR decision →

Related product codes

Other codes under 21 CFR 866.5900.

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