FDA product code · Physical medicine

Cane

Name: FDA decisions, review times, recalls and adverse event reports for product code IPS
Creator: 510(k) Report

IPSClass I21 CFR 890.3075510(k) exempt9 decisions since 19774 recalls

FDA lists IPS 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. 9 FDA decisions since 1977. 4 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 IPS 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 · IPS

FDA has decided no IPS device since 2007.

Median 510(k) review, days · IPS

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

Recalls per year · IPS

No recall names IPS since 2007.

Adverse event reports per year · IPS

7in 2025

2007high 96 (2014) · low 4 (2007)2025

MAUDE reports naming product code IPS, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	4
2008	—	4
2009	—	7
2010	—	5
2011	—	17
2012	—	55
2013	—	59
2014	—	96
2015	—	22
2016	—	21
2017	—	17
2018	—	13
2019	—	8
2020	—	4
2021	—	11
2022	—	10
2023	—	18
2024	—	5
2025	—	7
2026	—	—

FIG. 1 — IPS by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in IPS? 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 890.3075.

KHY Cane, Safety Walk

Cane

What has FDA decided in IPS lately?

What has been recalled in IPS lately?

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