# K852544: Monoject Sterile 3CC Syringes W/ & WO/ Needles

- Pathway: 510(k) (Traditional)
- Applicant: Sherwood Medical Co.
- Decided: Jul 23, 1985 after 39 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 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
- K070596: Topical Applicator (2007), 1 descendant of its own
- K093584: EZ-Mister (2011), 0 descendants of its own

## Recalls of this device
- Sep 11, 2006 · Not classified · Z-0051-2007: Incorrect needle: There is an incorrect needle configuration on the syringe. The correct needle has a 27 gage A-bevel, the needle on the syringe has no bevel, typically used for dental irrigation.

Source page: https://510kreport.com/device/K852544
Methodology: https://510kreport.com/methodology