FDA product code · Physical medicine

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

KNMClass I21 CFR 890.5765510(k) exempt2 decisions since 19780 recalls

FDA lists KNM 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. 2 FDA decisions since 1978. 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 KNM 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 · KNM

FDA has decided no KNM device since 2007.

Median 510(k) review, days · KNM

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

Recalls per year · KNM

No recall names KNM since 2007.

Adverse event reports per year · KNM

1in 2024

2007high 2 (2013) · low 0 (2007)2025

MAUDE reports naming product code KNM, 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	—	2
2014	—	0
2015	—	0
2016	—	1
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	1
2024	—	1
2025	—	0
2026	—	—

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

Planning a device in KNM? 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

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What has FDA decided in KNM lately?