510(k) Report

FDA product code · Cardiovascular

Trousers, Anti-Shock

LHXClass II21 CFR 870.5800510(k) required4 decisions since 19811 recall

4 FDA decisions since 1981. 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, cardiovascular panel

Twenty years of LHX 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 · LHX

FDA has decided no LHX device since 2007.

Median 510(k) review, days · LHX

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

Recalls per year · LHX

1in 2010

2010: 1
2007high 1 (2010) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LHX

1in 2025

2007: 12013: 72014: 42015: 82016: 22017: 52018: 102019: 262020: 22021: 52022: 142023: 112024: 32025: 1
2007high 26 (2019) · low 0 (2008)2025

MAUDE reports naming product code LHX, 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—01
20080—00
20090—00
20100—10
20110—00
20120—00
20130—07
20140—04
20150—08
20160—02
20170—05
20180—010
20190—026
20200—02
20210—05
20220—014
20230—011
20240—03
20250—01
20260—0—
FIG. 1 — LHX by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in LHX? 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 870.5800.