QEH · Class II · 21 CFR 880.5860

FDA Product Code QEH: Piston Syringe With Neuraxial Connector – Epidural, Peripheral, And/or Indirect Cerebral Spinal Fluid Contact

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.

Leading manufacturers include Jiangsu Caina Medical Co.,Ltd, Becton, Dickinson and Company and International Medical Industries, Inc..

5
Total
5
Cleared
204d
Avg days
2018
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times improving: avg 59d recently vs 241d historically

FDA 510(k) Cleared Piston Syringe With Neuraxial Connector – Epidural, Peripheral, And/or Indirect Cerebral Spinal Fluid Contact Devices (Product Code QEH)

5 devices
1–5 of 5
Cleared Jul 13, 2024
Omnifix Syringe NRFit
K241385
B.Braun Medical, Inc.
General Hospital · 59d
Cleared May 19, 2022
Artiglass NRFitTM Tip L.O.R. Glass Syringes
K213800
Artiglass Srl
Anesthesiology · 164d
Cleared Dec 16, 2020
NRFit® Caps, Male and Female Neuraxial Tip Caps
K201031
International Medical Industries, Inc.
General Hospital · 240d
Cleared Sep 04, 2020
BD Syringe NRFit Lok and BD Syringe NRFit Slip
K192538
Becton, Dickinson and Company
General Hospital · 354d
Cleared Dec 14, 2018
NRFit Syringe
K181374
Jiangsu Caina Medical Co.,Ltd
General Hospital · 204d

About Product Code QEH - Regulatory Context

510(k) Submission Activity

5 total 510(k) submissions under product code QEH since 2018, with 5 receiving FDA clearance (average review time: 204 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - QEH Product Code

Recent submissions under QEH have taken an average of 59 days to reach a decision - down from 241 days historically, suggesting improved FDA processing for this classification.

QEH devices are reviewed by the General Hospital panel. Browse all General Hospital devices →