# K070801: Imm Hypodermic Needle Set

- Pathway: 510(k) (Traditional)
- Applicant: Innovative Medical Manufacturing Co.
- Decided: May 24, 2007 after 62 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 K771204 (1977). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955053: Nipro Scalp Vein Set (Disposabl PSV Set), Nissho Corp. (1996) Summary page 1.
- K771204: Surflo Winged Infusion Set, Terumo America, Inc. (1977) Summary page 1.

## Indications for use
The IMM TM Hypodermic Needle Set is to be used for sampling blood from or infusing fluid into body system underneath the skin.

Source page: https://510kreport.com/device/K070801
Methodology: https://510kreport.com/methodology