# K962802: Safe Mate I.V. Fluid Delivery Sets

- Pathway: 510(k) (Traditional)
- Applicant: Biological & Environmental Control Laboratories
- Decided: Aug 28, 1996 after 41 days
- Product code: FPA (Set, Administration, Intravascular)
- 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: 1 generation back to K931173 (1994). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945070: Versasae Plastic Cannula- 11 Gauge, Imed Corp. (1995) Summary page 1.
- K944320: Vented/Non-Vented Gemini Administration Set, Imed Corp. (1995) Summary page 1.
- K931173: Primary Admin Set W/Univ SP-Man Below/Abv Pump CH, Imed Corp. (1994) Summary page 1.

## Indications for use
These I.V. Fluid Delivery Sets are intended to provide additional protection against inadvertent "needlestick” injuries to health care providers during the intravascular administration of fluids and medications. The I.V. Fluid Delivery Sets provide for the entry into an intravascular administration system without the need of a sharp needle by allowing for the penetration of a split septum injection sites or split septum Y-sites using an 11 gauge blunt plastic cannula.

Source page: https://510kreport.com/device/K962802
Methodology: https://510kreport.com/methodology