FDA product code QEH: Piston Syringe With Neuraxial Connector Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact
QEH is the FDA product code for piston syringe with neuraxial connector epidural, peripheral, and/or indirect cerebral spinal fluid contact. It is a Class II device, regulated under 21 CFR 880.5860 and reviewed by the General Hospital panel. FDA has cleared 5 510(k) submissions under QEH, 2 in the last five years, from 5 different applicants. The average 510(k) review took 204 days (median 204); 59 days on average over the last three years.
Definition
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.
Classification
| Field | Value |
|---|---|
| Device name | Piston Syringe With Neuraxial Connector Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact |
| Device class | Class II |
| Regulation | 21 CFR 880.5860 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
510(k) clearances per year for QEH
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 204 |
| 2020 | 2 | 297 |
| 2022 | 1 | 164 |
| 2024 | 1 | 59 |
Compare with all 510(k) review times · Search every QEH clearance
Top QEH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| B.Braun Medical, Inc. | 1 | 2024-07-13 |
| Artiglass Srl | 1 | 2022-05-19 |
| International Medical Industries, Inc. | 1 | 2020-12-16 |
| Becton, Dickinson and Company | 1 | 2020-09-04 |
| Jiangsu Caina Medical Co.,Ltd | 1 | 2018-12-14 |
Most recent QEH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K241385 | B.Braun Medical, Inc. | Omnifix Syringe NRFit | 2024-07-13 | 59 |
| K213800 | Artiglass Srl | Artiglass NRFitTM Tip L.O.R. Glass Syringes | 2022-05-19 | 164 |
| K201031 | International Medical Industries, Inc. | NRFit® Caps, Male and Female Neuraxial Tip Caps | 2020-12-16 | 240 |
| K192538 | Becton, Dickinson and Company | BD Syringe NRFit Lok and BD Syringe NRFit Slip | 2020-09-04 | 354 |
| K181374 | Jiangsu Caina Medical Co.,Ltd | NRFit Syringe | 2018-12-14 | 204 |
Recalls for QEH devices
openFDA lists no recalls for product code QEH.
Frequently asked questions
What is FDA product code QEH?
QEH is the FDA product code for piston syringe with neuraxial connector epidural, peripheral, and/or indirect cerebral spinal fluid contact. It is a Class II device, regulated under 21 CFR 880.5860 and reviewed by the General Hospital panel.
What device class is QEH?
Class II, regulation 21 CFR 880.5860. Typical premarket route: 510(k).
How long does a 510(k) take for product code QEH?
Across 5 cleared submissions the average was 204 days from receipt to decision (median 204).
Which companies have the most QEH clearances?
B.Braun Medical, Inc. (1); Artiglass Srl (1); International Medical Industries, Inc. (1); Becton, Dickinson and Company (1); Jiangsu Caina Medical Co.,Ltd (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QEH
- Run a recall and safety report across every QEH manufacturer
- Watch product code QEH for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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