# K883014: Modified Intended Use of Monoject Bone Marrow Need

- Pathway: 510(k) (Traditional)
- Applicant: Sherwood Medical Co.
- Decided: Jul 28, 1988 after 9 days
- Product code: GAA (Needle, Aspiration And Injection, Disposable)
- Device class: 1
- Regulation: 21 CFR 878.4800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
8 later devices descend from it; 1 cites it directly.
0 of 9 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
- K970380: F.a.S.T. 1 Intraosseous Infusion System (1997), 7 descendants of its own
- K072487: FAST1 Intraosseous Infusion System (2008), 4 descendants of its own
- K080865: FAST1 Intraosseous Infusion System (2008), 3 descendants of its own
- K100124: Fastx Sternal Intraosseous Device (2010), 2 descendants of its own
- K130487: Fastresponder Sternal Intraosseous Device (2013), 1 descendant of its own

Source page: https://510kreport.com/device/K883014
Methodology: https://510kreport.com/methodology