# K162219: CADD® Infusion Disposables Portfolio with NRFit™ connectors

- Pathway: 510(k) (Traditional)
- Applicant: Smiths Medical Asd, Inc.
- Decided: Jul 20, 2017 after 346 days
- Product code: PWH (Administrations Sets With Neuraxial Connectors)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 2 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K965017 (1997). 11 ancestors in all.
1 later device descends from it; 1 cites it directly.
3 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040636: Cadd Administration Set with Flow Stop, Medication Cassette Reservoir with Flow Stop and Extension Set, Smiths Medical MD, Inc. (2004) Summary page 6.
- K081156: Cadd Medication Cassette Reservoir, Smiths Medical MD, Inc. (2008) Summary page 6.
- K110053: Correctinject Safety System, Catheter Connector, Filter, Infusion Adaptor, Syringe Kit, Smiths Medical Asd, Inc. (2012) Summary page 6.
- K942046: Pharmacia Deltec Extension Set with Anti-Siphon Valve, Pharmacia Deltec, Inc. (1994) Summary page 7.
- K974013: Extension Set with Microbore Tubing, Extension Set with Microbore Tubing and 0.2 U Filter, Extension Set with Microbore, Sims Deltec, Inc. (1997) Summary page 7.

## Most influential descendants
- K211649: PCEA Syringe Set (2021), 0 descendants of its own

## Recalls of this device
- Aug 20, 2026 · Class II · Z-3212-2026: Reservoirs may exhibit medication leakage at the joint between luer connector and tubing. Issue could result in delay or interruption of therapy, under delivery of medication, exposure to infectious o
- Dec 9, 2022 · Class I · Z-0965-2023: There are two potential issues with CADD Infusion System Infusion Sets: (1) Lack of Delivery or Underdelivery related to Tubing Occlusion and (2) False "No Disposable Attached (NDA)" Alarms

## Indications for use
CADD Yellow Medication Cassette Reservoirs with NRFit™ connectors are designed for use only with NRFit™ components for delivery of regional anesthetics or narcotics, and are designed for use with CADD pumps (see CADD pump Operator’s Manual for compatibility) and CADD Yellow Extension Sets with NRFit™ connectors. The CADD Filling Adapter with male NRFit™ connector and female Luer is an accessory for use in filling of the CADD Medication Cassette Reservoirs with NRFit™ Connector. CADD Yellow Extension Sets with NRFit™ connectors are designed for use only with CADD Yellow Medication Cassette Reservoirs with NRFit™ connectors for the delivery of regional anesthetics or narcotics. CADD Yellow Administration Sets with NRFit™ connectors are designed for use only with NRFit™ components for delivery of regional anesthetics or narcotics and are designed for use with CADD pumps (see CADD pump Operator’s Manual for compatibility). The Male Yellow Cap with NRFit™ connector is intended for use as an accessory with the CADD Yellow Medication Cassette reservoirs. The Female Yellow Cap with NRFit™ connector is intended for use as an accessory with the CADD Yellow Extension sets with NRFit™ connectors and the CADD Yellow Administration sets with NRFit™ connector. The CADD Infusion Adapter with male NRFit™ connector and female Luer is intended to be used by clinicians to convert administration sets with Luer connectors into permanently dedicated lines for use only with NRFit connectors. The NRFit™ connector with non-luer taper is intended for the injection or infusion of regional anesthetics or narcotics and may help reduce the risk of mis-connection or mis-injection. The Intended population is pediatrics and adults.

Source page: https://510kreport.com/device/K162219
Methodology: https://510kreport.com/methodology