# K110053: Correctinject Safety System, Catheter Connector, Filter, Infusion Adaptor, Syringe Kit

- Pathway: 510(k) (Traditional)
- Applicant: Smiths Medical Asd, Inc.
- Decided: Sep 14, 2012 after 616 days
- Product code: CAZ (Anesthesia Conduction Kit)
- Device class: 2
- Regulation: 21 CFR 868.5140
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K965017 (1997). 5 ancestors in all.
5 later devices descend from it; 3 cite it directly.
1 of 11 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K965017: Regional Anesthesia Trays, Smiths Industries Medical Systems, Inc. (1997) Summary page 1.
- K092657: Epifuse Catheter Connector, Model: 4909E, Smiths Medical Asd, Inc. (2009) Summary page 1.
- K083451: Portex Epidural Filter, Model 100/386/010, Various Standard and Custom Trays, Smiths Medical Asd, Inc. (2009) Summary page 1.
- K980987: Becton Dickinson Syringe, Bd Becton Dickinson Vacutainer Systems Preanalytic (1998) Summary page 1.
- K801343: B-D Filter Needle, Bd Becton Dickinson Vacutainer Systems Preanalytic (1980) Summary page 1.

## Most influential descendants
- K170900: DASH 6 NRFit Lock Syringe + Accessories, DASH 6 NRFit Slip Syringe + Accessories, DASH 6 NRFit Plastic LOR Syringe + Accessories (2017), 1 descendant of its own
- K162219: CADD® Infusion Disposables Portfolio with NRFit™ connectors (2017), 1 descendant of its own
- K211649: PCEA Syringe Set (2021), 0 descendants of its own
- K201031: NRFit® Caps, Male and Female Neuraxial Tip Caps (2020), 0 descendants of its own
- K172410: Portex NRFit Epidural Needles, Portex NRFit Spinal Needles, Portex NRFit Loss of Resistance (L.O.R.) Syringes., Portex EpiFuse Catheter Connector, Portex Regional Anaesthesia Portfolio Filters (2018), 0 descendants of its own

## Indications for use
The CorrectInject™ Safety System is intended for the injection of local or regional anesthetics, narcotics or other medications indicated for neuraxial injection. The system consists of components that have a unique non-Luer taper that allows connection of compatible CorrectInject™ components that, when used together as a system, help reduce the risk of mis-connection that may result in the injection of medications not intended for neuraxial use. The CorrectInject™ Catheter Connector is intended for use with an epidural anesthesia catheter and CorrectInject™ compatible components for the injection of local or regional anesthetics, narcotics or other medications indicated for injection into the epidural space. The CorrectInject™ Syringe is intended for use with CorrectInject™ compatible components for the injection of medications. The CorrectInject™ anesthesia conduction filter is a microporous filter used while administering to a patient injections of local anesthetics to minimize particulate (foreign material) contamination of the injected fluid when used with CorrectInject™ compatible components. The CorrectInject™ filter needle is intended to draw up medication when using the CorrectInject™ Syringe. The CorrectInject™ white transport cap is intended to fit the CorrectInject™ syringe. The CorrectInject™ yellow cap is intended to fit the female side of the CorrectInject™ catheter connector or CorrectInject™ filter.

Source page: https://510kreport.com/device/K110053
Methodology: https://510kreport.com/methodology