FDA product code · Anesthesiology

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

KHAClass I21 CFR 868.5590510(k) exempt1 decision since 19970 recalls

FDA lists KHA as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 868.9 applies, such as a new intended use or a different fundamental technology. 1 FDA decision since 1997. 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, anesthesiology panel

Twenty years of KHA 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 · KHA

FDA has decided no KHA device since 2007.

Median 510(k) review, days · KHA

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

Recalls per year · KHA

No recall names KHA since 2007.

Adverse event reports per year · KHA

3in 2022

2007high 3 (2022) · low 0 (2007)2025

MAUDE reports naming product code KHA, 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	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	2
2021	—	1
2022	—	3
2023	—	0
2024	—	0
2025	—	0
2026	—	—

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

Planning a device in KHA? 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 KHA lately?