510(k) Report

FDA product code · General hospital

Chair And Table, Medical

KMNClass I21 CFR 880.6140510(k) exempt3 decisions since 19760 recalls

FDA lists KMN as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 880.9 applies, such as a new intended use or a different fundamental technology. 3 FDA decisions since 1976. 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, general hospital panel

Twenty years of KMN 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 · KMN

FDA has decided no KMN device since 2007.

Median 510(k) review, days · KMN

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

Recalls per year · KMN

No recall names KMN since 2007.

Adverse event reports per year · KMN

1in 2025

2007: 32009: 62010: 52011: 72012: 112013: 62014: 82015: 222016: 112017: 22018: 72019: 22020: 32022: 22023: 102024: 12025: 1
2007high 22 (2015) · low 0 (2008)2025

MAUDE reports naming product code KMN, 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—00
20090—06
20100—05
20110—07
20120—011
20130—06
20140—08
20150—022
20160—011
20170—02
20180—07
20190—02
20200—03
20210—00
20220—02
20230—010
20240—01
20250—01
20260—0—
FIG. 1 — KMN by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in KMN? 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 880.6140.