510(k) Report

FDA product code · Physical medicine

Tips And Pads, Cane, Crutch And Walker

INPClass I21 CFR 890.3790510(k) exempt8 decisions since 19803 recalls

FDA lists INP as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 890.9 applies, such as a new intended use or a different fundamental technology. 8 FDA decisions since 1980. 3 recalls name this code, 0 of them 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, physical medicine panel

Twenty years of INP 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 · INP

FDA has decided no INP device since 2007.

Median 510(k) review, days · INP

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

Recalls per year · INP

No recall names INP since 2007.

Adverse event reports per year · INP

1in 2025

2007: 32008: 12009: 12010: 12011: 1282012: 52013: 1132014: 272015: 102016: 62018: 12019: 12020: 12022: 12023: 32024: 12025: 1
2007high 128 (2011) · low 0 (2017)2025

MAUDE reports naming product code INP, 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—03
20080—01
20090—01
20100—01
20110—0128
20120—05
20130—0113
20140—027
20150—010
20160—06
20170—00
20180—01
20190—01
20200—01
20210—00
20220—01
20230—03
20240—01
20250—01
20260—0—
FIG. 1 — INP by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in INP? 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