Cleared Traditional

K201031 - NRFit® Caps, Male and Female Neuraxial Tip Caps (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K201031 · International Medical Industries, Inc. · General Hospital
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Dec 2020
Decision
240d
Days
Class 2
Risk

K201031 is an FDA 510(k) clearance for the NRFit® Caps, Male and Female Neuraxial Tip Caps. Classified as Piston Syringe With Neuraxial Connector – Epidural, Peripheral, And/or Indirect Cerebral Spinal Fluid Contact (product code QEH), Class II - Special Controls.

Submitted by International Medical Industries, Inc. (Pompano Beach, US). The FDA issued a Cleared decision on December 16, 2020 after a review of 240 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all International Medical Industries, Inc. devices

Submission Details

510(k) Number K201031 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 2020
Decision Date December 16, 2020
Days to Decision 240 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
112d slower than avg
Panel avg: 128d · This submission: 240d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QEH Piston Syringe With Neuraxial Connector – Epidural, Peripheral, And/or Indirect Cerebral Spinal Fluid Contact
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - QEH Piston Syringe With Neuraxial Connector – Epidural, Peripheral, And/or Indirect Cerebral Spinal Fluid Contact

Devices cleared under the same product code (QEH) and FDA review panel - the closest regulatory comparables to K201031.
Omnifix Syringe NRFit
K241385 · B.Braun Medical, Inc. · Jul 2024
Artiglass NRFitTM Tip L.O.R. Glass Syringes
K213800 · Artiglass Srl · May 2022
BD Syringe NRFit Lok and BD Syringe NRFit Slip
K192538 · Becton, Dickinson and Company · Sep 2020