510(k) Report

FDA product code · Physical medicine

Transport, Patient, Powered

ILKClass II21 CFR 890.5150510(k) required36 decisions since 19771 recall

36 FDA decisions since 1977. 510(k) reviews decided 2021–2025 took a median of 161 days (half between 144 and 177). 1 recall names this code; it is not Class I. The most-cited predicate is K103122, named by 2 later devices.

A powered patient transport is a motorized device intended for use in mitigating mobility impairment caused by injury or other disease by moving a person from one location or level to another, such as up and down flights of stairs (e.g., attendant-operated portable stair-climbing chairs). This generic type of device does not include motorized three-wheeled vehicles or wheelchairs.

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 ILK 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 · ILK

1in 2024

2008: 12009: 12010: 22011: 12012: 32014: 12023: 12024: 1
2007high 3 (2012) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · ILK

150in 2012

2012: 150 days median
2007high 150 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · ILK

1in 2012

2012: 1
2007high 1 (2012) · low 0 (2007)2026

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

Adverse event reports per year · ILK

32in 2025

2007: 12008: 42010: 12011: 12012: 42013: 42014: 22015: 22023: 52024: 182025: 32
2007high 32 (2025) · low 0 (2009)2025

MAUDE reports naming product code ILK, 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
20081—04
20091—00
20102—01
20111—01
2012315014
20130—04
20141—02
20150—02
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20231—05
20241—018
20250—032
20260—0—
FIG. 1 — ILK by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in ILK? 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 890.5150.