# K992699: Nipro Blood Collection Needle

- Pathway: 510(k) (Traditional)
- Applicant: Nipro Medical Corp.
- Decided: Feb 14, 2000 after 186 days
- Product code: FMI (Needle, Hypodermic, Single Lumen)
- Device class: 2
- Regulation: 21 CFR 880.5570
- 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 K861152 (1986). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K861152: Exel Vacuum Blood Collecting System, Exel Intl. (1986) Summary page 1.

## Most influential descendants
- K090426: Vaku-8 Blood Collection Needles (2009), 1 descendant of its own
- K153388: IMPROSAFE Blood Collection Set with Pre-attached Holder, IMPROVACUTER Blood Collection Set Pre-attached Holder, IMPROSAFE Blood Collection Set, IMPROVACUTER Blood Collection Set, IMPROSAFE Multi Sample Needle, IMPROSAFE Multi Sample Needle (Flashback), IMPROVACUTER Multi Sample Needle (2016), 0 descendants of its own

## Indications for use
The Nipro Blood Collection Needle are intended to be used to collect blood for various blood tests.

Source page: https://510kreport.com/device/K992699
Methodology: https://510kreport.com/methodology