# K201031: NRFit® Caps, Male and Female Neuraxial Tip Caps

- Pathway: 510(k) (Traditional)
- Applicant: International Medical Industries, Inc.
- Decided: Dec 16, 2020 after 240 days
- Product code: QEH (Piston Syringe With Neuraxial Connector – Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact  )
- Device class: 2
- Regulation: 21 CFR 880.5860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K965017 (1997). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170900: DASH 6 NRFit Lock Syringe + Accessories, DASH 6 NRFit Slip Syringe + Accessories, DASH 6 NRFit Plastic LOR Syringe + Accessories, Intervene Group, Ltd. (2017) Summary page 5.

## Indications for use
The NRFit® cap is a sterile, single-use device intended to provide positive closure to prevent fluid loss and contamination in Neuraxial devices CADD Cassettes or Syringes utilizing NRFit® connections. The NRFit® cap is intended to be used for less than 24 hours on any single application.

Source page: https://510kreport.com/device/K201031
Methodology: https://510kreport.com/methodology