# K861153: Disposable Syringes and Hypodermic Needles

- Pathway: 510(k) (Traditional)
- Applicant: Exel Intl.
- Decided: Apr 23, 1986 after 28 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
35 later devices descend from it; 1 cites it directly.
0 of 36 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
- K072587: Cytori Aft System (2007), 34 descendants of its own
- K092482: Tissu Trans Filtron, Models 3-TT-Filtron 2000-500 (2009), 17 descendants of its own
- K081848: Lipose Fat Transfer System (2008), 12 descendants of its own
- K120902: GID 700 (2012), 11 descendants of its own
- K100114: Fat Concentration System (2010), 8 descendants of its own

Source page: https://510kreport.com/device/K861153
Methodology: https://510kreport.com/methodology