510(k) Report

FDA product code · Clinical chemistry

Urinary Carbohydrate Analysis Kit

MPGClass I21 CFR 862.1505510(k) exempt1 decision since 19950 recalls

FDA lists MPG 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. 1 FDA decision since 1995. No recall names this code.

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 MPG 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 · MPG

FDA has decided no MPG device since 2007.

Median 510(k) review, days · MPG

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

Recalls per year · MPG

No recall names MPG since 2007.

Adverse event reports per year · MPG

No MAUDE report names MPG 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
20130—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 — MPG by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in MPG? 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

What has FDA decided in MPG lately?

  • K945519Face (Fluorophore-Assisted-Carbohydrate-Electrophoresis) Urinary Carbohydrate Analysis SystemPharmaquest Corp. · 1995

The one MPG decision →

Related product codes

Other codes under 21 CFR 862.1505.

JQN Colorimetric, Mucopolysaccharides