510(k) Report

FDA product code · General hospital

Catheter, Percutaneous, Long Term, Intraspinal

LNYClass IIIPMA required2 decisions since 19881 recall

2 FDA decisions since 1988. 1 recall names this code; it is not Class I.

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 LNY 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 · LNY

1in 2013

2007: 32009: 12010: 12013: 1
2007high 3 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LNY

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

Recalls per year · LNY

No recall names LNY since 2007.

Adverse event reports per year · LNY

1in 2025

2007: 52008: 12010: 12011: 102012: 302013: 172014: 52015: 22016: 12017: 22025: 1
2007high 30 (2012) · low 0 (2009)2025

MAUDE reports naming product code LNY, 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
20073—05
20080—01
20091—00
20101—01
20110—010
20120—030
20131—017
20140—05
20150—02
20160—01
20170—02
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—01
20260—0—
FIG. 1 — LNY by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in LNY? 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