# K202732: SOL-CARE IV Bag Safety Connector

- Pathway: 510(k) (Traditional)
- Applicant: Sol-Millennium Medical Group
- Decided: Nov 3, 2021 after 411 days
- Product code: LHI (Set, I.V. Fluid Transfer)
- Device class: 2
- Regulation: 21 CFR 880.5440
- 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 K790472 (1979). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083851: Inviroblunt Cannula with and Without EZ Wings, Models 120522 and 120022, Inviro Medical Devices, Inc. (2009) Summary page 4.

## Indications for use
The SOL-CARE IV Bag Safety Connector is designed for drug administration to I.V. bag without using sharp hypodermic needle attached to a drug pre-filled syringe. It incorporates a shielded needle to allow safe access through the injection port of I.V. bag.

Source page: https://510kreport.com/device/K202732
Methodology: https://510kreport.com/methodology