510(k) Report

FDA product code · General and plastic surgery

Prosthesis, Esophagus

JCQClass II21 CFR 878.3610510(k) required1 decision since 19890 recalls

1 FDA decision since 1989. 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, general and plastic surgery panel

Twenty years of JCQ 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 · JCQ

FDA has decided no JCQ device since 2007.

Median 510(k) review, days · JCQ

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

Recalls per year · JCQ

No recall names JCQ since 2007.

Adverse event reports per year · JCQ

1in 2025

2025: 1
2007high 1 (2025) · low 0 (2007)2025

MAUDE reports naming product code JCQ, 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—00
20230—00
20240—00
20250—01
20260—0—
FIG. 1 — JCQ by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in JCQ? 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 878.3610.