510(k) Report

FDA product code · General hospital

Catheter, Percutaneous, Intraspinal, Short Term

MAJClass II21 CFR 868.5120510(k) required6 decisions since 19890 recalls

6 FDA decisions since 1989. No recall names this code. The most-cited predicate is K893766, named by 1 later device.

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 hospital panel

Twenty years of MAJ 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 · MAJ

FDA has decided no MAJ device since 2007.

Median 510(k) review, days · MAJ

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

Recalls per year · MAJ

No recall names MAJ since 2007.

Adverse event reports per year · MAJ

18in 2025

2011: 12014: 12015: 32017: 22018: 72019: 32020: 52021: 32022: 42023: 82024: 42025: 18
2007high 18 (2025) · low 0 (2007)2025

MAUDE reports naming product code MAJ, 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—01
20120—00
20130—00
20140—01
20150—03
20160—00
20170—02
20180—07
20190—03
20200—05
20210—03
20220—04
20230—08
20240—04
20250—018
20260—0—
FIG. 1 — MAJ by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in MAJ? 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 868.5120.