FDA product code · Physical medicine

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

IPRClass I21 CFR 890.3150510(k) exempt4 decisions since 19775 recalls

FDA lists IPR 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. 4 FDA decisions since 1977. 5 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 IPR 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 · IPR

FDA has decided no IPR device since 2007.

Median 510(k) review, days · IPR

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

Recalls per year · IPR

No recall names IPR since 2007.

Adverse event reports per year · IPR

6in 2025

2007high 64 (2013) · low 3 (2021)2025

MAUDE reports naming product code IPR, 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	—	6
2008	—	6
2009	—	12
2010	—	13
2011	—	15
2012	—	34
2013	—	64
2014	—	53
2015	—	12
2016	—	9
2017	—	4
2018	—	4
2019	—	4
2020	—	5
2021	—	3
2022	—	4
2023	—	7
2024	—	3
2025	—	6
2026	—	—

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

Planning a device in IPR? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

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What has FDA decided in IPR lately?

What has been recalled in IPR lately?