# K922522: Monoject Safety Syringe, 1 CC, 3CC and 12 CC Sizes

- Pathway: 510(k) (Traditional)
- Applicant: Sherwood Medical Co.
- Decided: Nov 25, 1992 after 181 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
29 later devices descend from it; 5 cite it directly.
0 of 30 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
- K061492: Monoject Magellan Insulin and Tuberculin Safety Syringe (2006), 20 descendants of its own
- K132681: Sol-Guard Insulin and Tuberculin Safety Syringe (2014), 16 descendants of its own
- K192551: 1ml Luer Slip or Luer Lock Syringe, Syringe with permanently attached needle, Safety Syringe with permanently attached needle (2020), 14 descendants of its own
- K210443: PLPT LDV (Low Dead Volume) Sterile Syringe (2021), 6 descendants of its own
- K080600: Ultimed Ulticare Safety Syringe (2008), 3 descendants of its own

## Recalls of this device
- May 21, 2012 · Not classified · Z-1696-2012: Safety shield may separate from the syringe, exposing the needle, which could potentially result in a needle stick
- May 21, 2012 · Not classified · Z-1694-2012: Safety shield may separate from the syringe, exposing the needle, which could potentially result in a needle stick
- May 21, 2012 · Not classified · Z-1695-2012: Safety shield may separate from the syringe, exposing the needle, which could potentially result in a needle stick
- May 21, 2012 · Not classified · Z-1697-2012: Safety shield may separate from the syringe, exposing the needle, which could potentially result in a needle stick

Source page: https://510kreport.com/device/K922522
Methodology: https://510kreport.com/methodology