510(k) Report

FDA product code · Clinical chemistry

Insulin Pump Secondary Display

PKUClass II21 CFR 862.1350510(k) exempt0 decisions0 recalls

FDA lists PKU as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 862.9 applies, such as a new intended use or a different fundamental technology. 0 FDA decisions. No recall names this code.

The purpose of the insulin pump secondary display is to notify another person of the patient's insulin pump usage information in real time. The secondary display is intended for providing secondary notification of insulin pump usage and does not replace primary real time insulin pump monitoring or standard home blood glucose monitoring.

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 PKU 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 · PKU

FDA has decided no PKU device since 2007.

Median 510(k) review, days · PKU

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

Recalls per year · PKU

No recall names PKU since 2007.

Adverse event reports per year · PKU

11,900in 2025

2022: 6,0362023: 10,0832024: 9,6472025: 11,900
2007high 11,900 (2025) · low 0 (2007)2025

MAUDE reports naming product code PKU, 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
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—06,036
20230—010,083
20240—09,647
20250—011,900
20260—0—
FIG. 1 — PKU by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in PKU? 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 862.1350.

PJT Continuous Glucose Monitor Secondary Display