Cleared Traditional

K201031 - NRFit Caps

K201031 is an FDA 510(k) clearance for NRFit Caps, manufactured by International Medical Industries, Inc.. The device is a Class 2 General Hospital device with product code QEH cleared through the Traditional 510(k) pathway after a 240-day FDA review.

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

FDA 510(k) Submission Details - K201031

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
111d slower than avg
Panel avg: 129d · This submission: 240d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

QEH Device Classification - Class 2, Special Controls

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
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Artiglass NRFitTM Tip L.O.R. Glass Syringes
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BD Syringe NRFit Lok and BD Syringe NRFit Slip
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NRFit Syringe
K181374 · Jiangsu Caina Medical Co.,Ltd · Dec 2018