510(k) Report

FDA product code · Clinical chemistry

Molybdenum Blue Method, Phospholipids

CEQClass I21 CFR 862.1575510(k) exempt1 decision since 19860 recalls

FDA lists CEQ 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 1986. 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 CEQ 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 · CEQ

FDA has decided no CEQ device since 2007.

Median 510(k) review, days · CEQ

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

Recalls per year · CEQ

No recall names CEQ since 2007.

Adverse event reports per year · CEQ

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

Planning a device in CEQ? 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 CEQ lately?

  • K863071Phospholipids-EJ. D. Assoc. · 1986

The one CEQ decision →

Related product codes

Other codes under 21 CFR 862.1575.

CEL Ammonium Molybdate And Ammonium Vanadate…JNT Chromatographic, PhospholipidsJNS Stannous Chloride - Hydrazine, Phospholipids