510(k) Report

FDA product code · Clinical chemistry

Sensor, Glucose, Invasive, Non-Adjunctive

PQFClass IIIPMA required0 decisions since 20160 recalls

0 FDA decisions since 2016. No recall names this code.

A non-adjunctive invasive glucose sensor is intended to determine glucose levels, and the direction and rate of change of glucose levels in people with diabetes. The device is indicated to replace information obtained from standard blood glucose monitoring devices to make diabetes-related treatment decisions. The device also provides historical glucose information, facilitating long-term therapy adjustments.

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, clinical chemistry panel

Twenty years of PQF 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 · PQF

2in 2024

2016: 12017: 32018: 22019: 12024: 2
2007high 3 (2017) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PQF

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

Recalls per year · PQF

No recall names PQF since 2007.

Adverse event reports per year · PQF

38,140in 2025

2016: 32017: 65,1822018: 116,2452019: 44,5102020: 10,5792021: 4,9432022: 1,3782023: 6,3732024: 22,3892025: 38,140
2007high 116,245 (2018) · low 0 (2007)2025

MAUDE reports naming product code PQF, 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
20140—00
20150—00
20161—03
20173—065,182
20182—0116,245
20191—044,510
20200—010,579
20210—04,943
20220—01,378
20230—06,373
20242—022,389
20250—038,140
20260—0—
FIG. 1 — PQF by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in PQF? 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