# K173577: Guarded Luer Connector

- Pathway: 510(k) (Traditional)
- Applicant: International Medical Industries, Inc.
- Decided: Jun 7, 2018 after 199 days
- Product code: LHI (Set, I.V. Fluid Transfer)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K900585 (1990). 1 ancestor in all.
No later device cites it as a predicate yet.
1 of 2 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K900585: Tubing Sets for Baxa Exacta-Med Pharmacy Pump, Baxa Corp., Sub. of Cook Group, Inc. (1990) Summary page 4.

## Recalls of this device
- Sep 16, 2022 · Class II · Z-0925-2023: Blister package had an unsealed edge compromising sterility.

## Indications for use
The Guarded Luer Connector is a fluid transfer device used in the pharmacy to provide the fluid path for transferring large source container ingredients into a smaller container.

Source page: https://510kreport.com/device/K173577
Methodology: https://510kreport.com/methodology