# K962801: Safe Mate I.V. Extension 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: 2 generations back to K860605 (1986). 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)
- K955821: I.V. Administration Sets, Medical Associates Network, Inc. (1996) Summary page 1.
- K945070: Versasae Plastic Cannula- 11 Gauge, Imed Corp. (1995) Summary page 2.
- K944320: Vented/Non-Vented Gemini Administration Set, Imed Corp. (1995) Summary page 2.
- K931173: Primary Admin Set W/Univ SP-Man Below/Abv Pump CH, Imed Corp. (1994) Summary page 2.

## Indications for use
These I.V. Extension 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. Extension Sets provide for the entry to an intravascular administration set 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/K962801
Methodology: https://510kreport.com/methodology