# K092657: Epifuse Catheter Connector, Model: 4909E

- Pathway: 510(k) (Special)
- Applicant: Smiths Medical Asd, Inc.
- Decided: Nov 4, 2009 after 68 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: 1 generation back to K965017 (1997). 1 ancestor in all.
6 later devices descend from it; 1 cites it directly.
1 of 8 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.

## Most influential descendants
- K110053: Correctinject Safety System, Catheter Connector, Filter, Infusion Adaptor, Syringe Kit (2012), 5 descendants of its own
- 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

## Indications for use
The SIMS Regional Anesthesia Tray is used to administer patient regional or local anesthesia.

Source page: https://510kreport.com/device/K092657
Methodology: https://510kreport.com/methodology