NRFit® Caps, Male and Female Neuraxial Tip Caps
FDA 510(k) K201031 · International Medical Industries, Inc.
Submission
- Device name
- NRFit® Caps, Male and Female Neuraxial Tip Caps
- Applicant
- International Medical Industries, Inc.
Pompano Beach, FL, US - Received
- April 20, 2020
- Decision date
- December 16, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QEH – Piston Syringe With Neuraxial Connector Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5860
- Specialty
- General Hospital
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…
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|---|---|---|---|
| K241385 | Omnifix Syringe NRFitQEH · Traditional | B.Braun Medical, Inc. | 07/13/2024SE |
| K213800 | Artiglass NRFitTM Tip L.O.R. Glass SyringesQEH · Special | Artiglass Srl | 05/19/2022SE |
| K192538 | BD Syringe NRFit Lok and BD Syringe NRFit SlipQEH · Traditional | Becton, Dickinson and Company | 09/04/2020SE |
| K181374 | NRFit SyringeQEH · Traditional | Jiangsu Caina Medical Co.,Ltd | 12/14/2018SE |
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| K231095 | Tamper Evident CapFMF · Traditional | 09/04/2024SE |
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| K190305 | Additive CapKPE · Traditional | 04/30/2019SE |
| K182545 | Tamper Evident Cap with Male Luer LockFPA · Traditional | 01/11/2019SE |
| K173577 | Guarded Luer ConnectorLHI · Traditional | 06/07/2018SE |
| K170672 | Tamper Evident Cap For use with ENFit SyringesPNR · Traditional | 10/06/2017SE |
Questions and answers
When was NRFit® Caps, Male and Female Neuraxial Tip Caps cleared by the FDA?
NRFit® Caps, Male and Female Neuraxial Tip Caps (K201031) received a 510(k) decision of Substantially Equivalent on December 16, 2020, 240 days after the submission was received.
What is the product code of K201031?
The FDA product code is QEH – Piston Syringe With Neuraxial Connector Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact , a Class II (moderate risk) device regulated under 21 CFR 880.5860.