FDA product code · Physical medicine

Bed, Patient Rotation, Manual

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

INYClass I21 CFR 890.5180510(k) exempt1 decision since 19850 recalls

FDA lists INY 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. 1 FDA decision since 1985. No recall names this code.

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 INY 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 · INY

FDA has decided no INY device since 2007.

Median 510(k) review, days · INY

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

Recalls per year · INY

No recall names INY since 2007.

Adverse event reports per year · INY

1in 2016

2007high 1 (2013) · low 0 (2007)2025

MAUDE reports naming product code INY, 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	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	1
2014	—	0
2015	—	0
2016	—	1
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

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

Planning a device in INY? 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

Bed, Patient Rotation, Manual

What has FDA decided in INY lately?