# K940961: Monoject Luer Adapter

- Pathway: 510(k) (Traditional)
- Applicant: Sherwood Medical Co.
- Decided: Sep 14, 1994 after 196 days
- Product code: FMI (Needle, Hypodermic, Single Lumen)
- Device class: 2
- Regulation: 21 CFR 880.5570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
57 later devices descend from it; 1 cites it directly.
3 of 58 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K972527: Phaseal, System for Sealed Handling of Chemotherapeutic Agents (1997), 56 descendants of its own
- K980381: Phaseal, Closed System Forhandling of Parenteral Drugs, Additional Administration Devices. C80 Infusion Adapter, A10 Pro (1998), 49 descendants of its own
- K023747: Phaseal (2002), 38 descendants of its own
- K110023: Infusion Adapter C100 (2011), 37 descendants of its own
- K092782: Injector Luer, Model N34, Injector Luer Lock, Model N35, Injector Luer Lock, N35C, Connector Luer Lock, Model C35, (2009), 36 descendants of its own

Source page: https://510kreport.com/device/K940961
Methodology: https://510kreport.com/methodology