FDA product code · General hospital

Piston Syringe With Neuraxial Connector – Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact

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

QEHClass II21 CFR 880.5860510(k) required5 decisions since 20180 recalls

5 FDA decisions since 2018. 510(k) reviews decided 2021–2025 took a median of 112 days (half between 85 and 138). No recall names this code.

A neuraxial piston syringe is intended to inject or withdraw fluid from the neuraxial space with neuraxial specific connections. This product code may include epidural, peripheral, subarachnoid/spinal block, intrathecal and/or intracerebroventricular administration routes. The connector for neuraxial applications is intended to facilitate ANSI/AAMI/ISO 80369-6:2016 compliant neuraxial specific connections.

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 QEH 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 · QEH

1in 2024

2007high 2 (2020) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QEH

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

Recalls per year · QEH

No recall names QEH since 2007.

Adverse event reports per year · QEH

5in 2025

2007high 13 (2024) · low 0 (2007)2025

MAUDE reports naming product code QEH, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	1	—	0
2019	0	—	0
2020	2	—	0
2021	0	—	0
2022	1	—	2
2023	0	—	1
2024	1	—	13
2025	0	—	5
2026	0	—	—

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

Planning a device in QEH? 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 880.5860.

QOG Injection Data Capture Device MZM Fibrin Sealant Preparation Device QLF On-Body Injector FMF Syringe, Piston NSC Injector, Pen QLY Ophthalmic Syringe QBL Piston Syringe Lever NKN Syringe, Piston, Reprocessed PQX Epinephrine Syringe QNQ Low Dead Space Piston Syringe PUR Vacuum Syringe MEG Syringe, Antistick

Piston Syringe With Neuraxial Connector – Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact

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What has FDA decided in QEH lately?

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