510(k) Report

FDA product code · Physical medicine

Monitor, Spine Curvature

LZWClass U5 decisions since 19890 recalls

5 FDA decisions since 1989. No recall names this code. The most-cited predicate is K951244, named by 2 later devices.

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, physical medicine panel

Twenty years of LZW 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 · LZW

1in 2010

2009: 12010: 1
2007high 1 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LZW

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

Recalls per year · LZW

No recall names LZW since 2007.

Adverse event reports per year · LZW

1in 2025

2021: 12025: 1
2007high 1 (2021) · low 0 (2007)2025

MAUDE reports naming product code LZW, 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
20091—00
20101—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—01
20220—00
20230—00
20240—00
20250—01
20260—0—
FIG. 1 — LZW by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in LZW? 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