# K861152: Exel Vacuum Blood Collecting System

- Pathway: 510(k) (Traditional)
- Applicant: Exel Intl.
- Decided: May 6, 1986 after 41 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
No predicates in its family tree.
6 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K992699: Nipro Blood Collection Needle (2000), 2 descendants of its own
- K992729: Nipro Luer Adaptor (2000), 2 descendants of its own
- K090426: Vaku-8 Blood Collection Needles (2009), 1 descendant of its own
- K021941: Samplok Luer Kit (2002), 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

Source page: https://510kreport.com/device/K861152
Methodology: https://510kreport.com/methodology