FDA product code · Obstetrics and gynecology

Set, Anesthesia, Obstetric

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

KNEClass II21 CFR 884.5100510(k) required2 decisions since 19860 recalls

2 FDA decisions since 1986. 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, obstetrics and gynecology panel

Twenty years of KNE 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 · KNE

FDA has decided no KNE device since 2007.

Median 510(k) review, days · KNE

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

Recalls per year · KNE

No recall names KNE since 2007.

Adverse event reports per year · KNE

4in 2014

2007high 4 (2014) · low 0 (2007)2025

MAUDE reports naming product code KNE, 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	—	4
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

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

Planning a device in KNE? 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 884.5100.

HEE Set, Anesthesia, Paracervical PVU Obstetrical Anesthesia Kit HEG Set, Anesthesia, Pudendal PVW Pudendal Anesthesia Kit PVV Paracervical Anesthesia Kit

Set, Anesthesia, Obstetric

What has FDA decided in KNE lately?

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